Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2026-02-18 @ 8:18 PM
Study NCT ID:
NCT00552032
Status:
COMPLETED
Last Update Posted:
2024-05-20
First Post:
2007-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Mometasone Furoate Nasal Spray in Children With Adenoid Hypertrophy. SNORE Study (P05155)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Mexico']}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp'}, 'certainAgreement': {'otherDetails': 'The Principal Investigator agrees not to publish or publicly present any interim results of the Study without prior written consent of the SPONSOR. The Principal Investigator further agrees to provide thirty (30) days written notice to the SPONSOR prior to submission for publication or presentation to permit the SPONSOR to review copies of abstracts or manuscripts for publication which report any results of the Study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The results of this study as presented are drawn from the clinical study report and should be reviewed with caution as there were inaccuracies in the database resulting from medication errors in some participants.'}}, 'adverseEventsModule': {'timeFrame': 'Up to Week 24', 'eventGroups': [{'id': 'EG000', 'title': 'Mometasone Furoate Nasal Spray', 'description': '1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).', 'otherNumAtRisk': 66, 'otherNumAffected': 18, 'seriousNumAtRisk': 66, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Placebo Nasal Spray', 'description': '1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).', 'otherNumAtRisk': 66, 'otherNumAffected': 17, 'seriousNumAtRisk': 66, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 10, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pharyngotonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 14, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}], 'seriousEvents': [{'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Orchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Oropharyngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Adenoid/Choana (A/C) Index Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone Furoate Nasal Spray (MFNS)', 'description': '1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).'}, {'id': 'OG001', 'title': 'Placebo Nasal Spray', 'description': '1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).'}], 'classes': [{'title': 'Change at Visit 3 (n=65 MFNS, n=63 Placebo)', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Change at Visit 4 (n=61 MFNS, n=58 Placebo)', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (visit 2), Weeks 4 (visit 3), Week 8 (visit 4)', 'description': 'Changes in adenoid size were assessed by nasopharyngoscopic examination and were determined using the Adenoid/Choana (A/C) Index. Grades were assigned to intervals of A/C ratio percentages: grade I (0-25%), II (26-50%), III (51-75%) and IV (76-100%). Changes in adenoid size were expressed as the mean difference between grades at baseline and study visit. Positive values indicated a decrease in adenoid size, a 0 value indicated that size remained the same, and negative values indicated an increase in adenoid size.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 132 participants were included in the intent-to-treat (ITT) population. The ITT population included all randomized participants who received at least one dose after commencement of treatment. Data are summarized in terms of the number of participants providing data at the relevant time point.'}, {'type': 'SECONDARY', 'title': 'Total Severity Symptom Scores: Morning and Evening (AM & PM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone Furoate Nasal Spray (MFNS)', 'description': '1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).'}, {'id': 'OG001', 'title': 'Placebo Nasal Spray', 'description': '1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).'}], 'classes': [{'title': 'Visit 2 AM (n=66 MFNS, n=66 Placebo)', 'categories': [{'measurements': [{'value': '9.4', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '9.9', 'spread': '3.3', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3 AM (n=64 MFNS, n=65 Placebo)', 'categories': [{'measurements': [{'value': '5.4', 'spread': '3.8', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '3.7', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4 AM (n=62 MFNS, n=60 Placebo)', 'categories': [{'measurements': [{'value': '4.2', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '3.5', 'groupId': 'OG001'}]}]}, {'title': 'Visit 2 PM (n=66 MFNS, n=66 Placebo)', 'categories': [{'measurements': [{'value': '9.9', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '10.2', 'spread': '2.8', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3 PM (n=64 MFNS, n=65 Placebo)', 'categories': [{'measurements': [{'value': '6.3', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '7.0', 'spread': '3.6', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4 PM (n=62 MFNS, n=60 Placebo)', 'categories': [{'measurements': [{'value': '4.8', 'spread': '3.8', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '3.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)', 'description': 'Symptoms were assessed by whole-number linear scale to grade their severity. Scores were recorded AM \\& PM (a difference of 12 hours) \\& were based on severity within 12 hours of prior recording. The following symptoms were evaluated: Snoring; Nasal obstruction \\& discharge; Breathing difficulty; Oral respiration; Ear pain. Severity was graded according to the following scale: 0=absent; 1=mild; 2=moderate; 3=severe. Severity was scored individually and summed to obtain the Total Symptom Severity Score. The maximum total score possible was 36 daily; 18 for both AM (6 symptoms times max severity of 3)and PM.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 132 participants were included in the ITT population. The ITT population included all randomized participants who received at least one dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point.'}, {'type': 'SECONDARY', 'title': 'Total Frequency Symptom Scores: AM & PM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone Furoate Nasal Spray (MFNS)', 'description': '1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).'}, {'id': 'OG001', 'title': 'Placebo Nasal Spray', 'description': '1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).'}], 'classes': [{'title': 'Visit 2 AM (n=66 MFNS, n=66 Placebo)', 'categories': [{'measurements': [{'value': '7.3', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '7.3', 'spread': '2.4', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3 AM (n=64 MFNS, n=65 Placebo)', 'categories': [{'measurements': [{'value': '4.4', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '2.6', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4 AM (n=62 MFNS, n=60 Placebo)', 'categories': [{'measurements': [{'value': '3.7', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '2.5', 'groupId': 'OG001'}]}]}, {'title': 'Visit 2 PM (n=66 MFNS, n=66 Placebo)', 'categories': [{'measurements': [{'value': '7.6', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '8.0', 'spread': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3 PM (n=64 MFNS, n=65 Placebo)', 'categories': [{'measurements': [{'value': '5.3', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '2.6', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4 PM (n=62 MFNS, n=60 Placebo)', 'categories': [{'measurements': [{'value': '4.1', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '2.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)', 'description': 'Symptoms were assessed by whole-number linear scale to grade their frequency. Scores were recorded AM \\& PM (a difference of 12 hours) \\& were based on frequency within 12 hours of prior recording. The following signs/symptoms were evaluated: Snoring; Nasal obstruction; and nasal discharge; Breathing difficulty; Oral respiration; Ear pain. Frequency was graded according to the following scale: 0=absent; 1=intermittent; 2=persistent. The frequency of symptoms was scored individually and summed to obtain the Total Frequency Symptom Score. The maximum total score possible was 24 daily; 12 for both AM (6 symptoms times max frequency of 2) and PM.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 132 participants were included in the ITT population. The ITT population included all randomized participants who received at least one dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Bilateral Tympanogram Results of: Normal, Abnormal, or Not Done', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone Furoate Nasal Spray (MFNS)', 'description': '1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).'}, {'id': 'OG001', 'title': 'Placebo Nasal Spray', 'description': '1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).'}], 'classes': [{'title': 'Visit 2- Normal (n=66 MFNS, n=66 Placebo)', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'Visit 2- Abnormal (n=66 MFNS, n=66 Placebo)', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Visit 2- Not Done (n=66 MFNS, n=66 Placebo)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3- Normal (n=65 MFNS, n=65 Placebo)', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3- Abnormal (n=65 MFNS, n=65 Placebo)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3- Not Done (n=65 MFNS, n=65 Placebo)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4- Normal (n=62 MFNS, n=60 Placebo)', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4- Abnormal (n=62 MFNS, n=60 Placebo)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4- Not Done (n=62 MFNS, n=60 Placebo)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)', 'description': "Tympanometry was performed in children ages 2-11 by certified audiologists. Results were categorized based on audiologist's assessment as either being normal (normal pressure in the middle ear with normal mobility of the eardrum and the conduction bones) , abnormal (abnormal pressure in the middle ear and/or abnormal mobility of the eardrum and the conduction bones), or tympanometry was not done (evaluation not completed). Results were assessed at baseline, Week 4 (Visit 3), and endpoint Week 8 (end of treatment).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 132 participants were included in the ITT\n\npopulation. The ITT population included all randomized participants who received at least one dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Otoscopic Results of: Normal or Abnormal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone Furoate Nasal Spray (MFNS)', 'description': '1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).'}, {'id': 'OG001', 'title': 'Placebo Nasal Spray', 'description': '1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).'}], 'classes': [{'title': 'Right Otoscopy: Visit 2- Normal (n=66, n=66)', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Right Otoscopy: Visit 2- Abnormal (n=66, n=66)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Right Otoscopy Visit 3- Normal (n=65, n=65)', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}, {'title': 'Right Otoscopy Visit 3- Abnormal (n=65, n=65)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Right Otoscopy Visit 4- Normal (n=62, n=60)', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}, {'title': 'Right Otoscopy Visit 4- Abnormal (n=62, n=60)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Left Otoscopy: Visit 2- Normal (n=66, n=66)', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}, {'title': 'Left Otoscopy: Visit 2- Abnormal (n=66, n=66)', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Left Otoscopy Visit 3- Normal (n=65, n=65)', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'Left Otoscopy Visit 3- Abnormal (n=65, n=65)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Left Otoscopy Visit 4- Normal (n=62, n=60)', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}, {'title': 'Left Otoscopy Visit 4- Abnormal (n=62, n=60)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)', 'description': "Otoscopic examination was performed of the right and left ear canals at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4). Results were categorized based on audiologist's assessment as either being normal (ear canal structures appear normal) or abnormal (ear canal structures appear abnormal).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 132 participants were included in the ITT population. The ITT population included all randomized participants who received at least one dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Rhinoscopic- Septum Results of: Aligned, Non-Obstructive, or Obstructive Deviation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone Furoate Nasal Spray (MFNS)', 'description': '1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).'}, {'id': 'OG001', 'title': 'Placebo Nasal Spray', 'description': '1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).'}], 'classes': [{'title': 'Visit 2 Aligned (n= 66, n=66)', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}, {'title': 'Visit 2 Non-obstructive Deviation (n= 66, n=66)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Vist 2 Obstructive Deviation (n=66, n=66)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3 Aligned (n=65, n=65)', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3 Non-obstructive Deviation (n=65, n=65)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3 Obstructive Deviation (n=65, n=65)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4 Aligned (n=62, n=60)', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4 Non-obstructive Deviation (n=62, n=60)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4 -Obstructive Deviation (n=62, n=60)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)', 'description': "Rhinoscopic examination of the septum was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4). Results were categorized based on investigator's assessment as either being aligned (septum is aligned), non-obstructive (septum is not aligned but the deviation is non-obstructive), or obstructive (septum is deviated and obstructive) deviation.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 132 participants were included in the ITT population. The ITT population included all randomized participants who received at least one dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Rhinoscopic-Inferior Turbinates Results of: Normal, Hypertrophic, and Hypotrophic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone Furoate Nasal Spray (MFNS)', 'description': '1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).'}, {'id': 'OG001', 'title': 'Placebo Nasal Spray', 'description': '1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).'}], 'classes': [{'title': 'Visit 2- Normal Appearance (n=66, n=66)', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': 'Visit 2 Hypertrophic (n=66, n=66)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Vist 2 Hypotrophic (n=66, n=66)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3 Normal Appearance (n=65, n=65)', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3 Hypertrophic (n=65, n=65)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3 Hypotrophic (n=65, n=65)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4 Normal Appearance (n=62, n=60)', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4 Hypertrophic (n=62, n=60)', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4 Hypotrophic (n=62, n=60)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)', 'description': "Rhinoscopic examination of the inferior turbinates was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4). Results were categorized based on investigator's assessment as either being normal appearance (normal size) , hypertrophic (swollen/normal size increased), or hypotrophic (normal size diminished).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 132 participants were included in the ITT population. The ITT population included all randomized participants who received at least one dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Rhinoscopic- Middle Meatus Results of: Patent, Partial Obstruction or Total Obstruction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone Furoate Nasal Spray (MFNS)', 'description': '1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).'}, {'id': 'OG001', 'title': 'Placebo Nasal Spray', 'description': '1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).'}], 'classes': [{'title': 'Visit 2- Patent (n=66, n=66)', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}, {'title': 'Visit 2- Partial Obstruction (n=66, n=66)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Visit 2- Total Obstruction (n=66, n=66)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3- Patent (n=65, n=65)', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3- Partial Obstruction (n=65, n=65)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3- Total Obstruction (n=65, n=65)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4- Patent (n=62, n=60)', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4- Partial Obstruction (n= 62, n=60)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4- Total Obstruction (n=62, n=60)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)', 'description': "Rhinoscopic examination of the middle meatus was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4). Results were categorized based on investigator's assessment into 3 categories: patent (easily observed), partial obstruction (partially blocked from view), or total obstruction (completely blocked from view).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 132 participants were included in the ITT population. The ITT population included all randomized participants who received at least one dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point.'}, {'type': 'SECONDARY', 'title': 'Rhinomanometry Results- Left and Right Nasal Fossa: Inspiratory Resistance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone Furoate Nasal Spray (MFNS)', 'description': '1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).'}, {'id': 'OG001', 'title': 'Placebo Nasal Spray', 'description': '1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).'}], 'classes': [{'title': 'Visit 2- Left Nasal Fossa (n=19, n=20)', 'categories': [{'measurements': [{'value': '2.111', 'spread': '4.372', 'groupId': 'OG000'}, {'value': '3.280', 'spread': '7.852', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3- Left Nasal Fossa (n=18, n=18)', 'categories': [{'measurements': [{'value': '6.341', 'spread': '22.759', 'groupId': 'OG000'}, {'value': '1.934', 'spread': '2.234', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4- Left Nasal Fossa (n=19, n=19)', 'categories': [{'measurements': [{'value': '31.074', 'spread': '131.718', 'groupId': 'OG000'}, {'value': '54.724', 'spread': '229.437', 'groupId': 'OG001'}]}]}, {'title': 'Visit 2- Right Nasal Fossa (n=19, n=20)', 'categories': [{'measurements': [{'value': '2.985', 'spread': '8.527', 'groupId': 'OG000'}, {'value': '6.535', 'spread': '24.836', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3- Right Nasal Fossa (n=18, n=18)', 'categories': [{'measurements': [{'value': '1.823', 'spread': '4.454', 'groupId': 'OG000'}, {'value': '3.026', 'spread': '8.258', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4- Right Nasal Fossa (n=19, n=19)', 'categories': [{'measurements': [{'value': '2.560', 'spread': '6.918', 'groupId': 'OG000'}, {'value': '43.621', 'spread': '174.535', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)', 'description': 'Rhinomanometry examination of the left \\& right Nasal Fossa was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4) in participants ages 7-11 years.\n\nRhinomanometry is a test of nasal function that measures air pressure and the rate of airflow in the nasal airway during respiration by means of equipment. These findings were used to calculate inspiratory nasal airway resistance reported in Pascal/centimeter\\^3/second (Pa/cm\\^3/sec).', 'unitOfMeasure': 'Pa/cm^3/sec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was only performed in a cohort of the ITT in participants aged 7-11 years old (MFSN=19, Placebo=20).'}, {'type': 'SECONDARY', 'title': 'Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Resistance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone Furoate Nasal Spray (MFNS)', 'description': '1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).'}, {'id': 'OG001', 'title': 'Placebo Nasal Spray', 'description': '1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).'}], 'classes': [{'title': 'Visit 2- Left Nasal Fossa (n=19, n=20)', 'categories': [{'measurements': [{'value': '1.771', 'spread': '2.764', 'groupId': 'OG000'}, {'value': '3.994', 'spread': '9.416', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3- Left Nasal Fossa (n=18, n=18)', 'categories': [{'measurements': [{'value': '2.937', 'spread': '8.196', 'groupId': 'OG000'}, {'value': '1.478', 'spread': '1.647', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4- Left Nasal Fossa (n=19, n=19)', 'categories': [{'measurements': [{'value': '13.488', 'spread': '32.344', 'groupId': 'OG000'}, {'value': '4.148', 'spread': '13.999', 'groupId': 'OG001'}]}]}, {'title': 'Visit 2- Right Nasal Fossa (n=19, n=20)', 'categories': [{'measurements': [{'value': '2.625', 'spread': '6.868', 'groupId': 'OG000'}, {'value': '1.083', 'spread': '1.109', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3- Right Nasal Fossa (n=18, n=18)', 'categories': [{'measurements': [{'value': '2.189', 'spread': '4.678', 'groupId': 'OG000'}, {'value': '3.646', 'spread': '8.313', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4- Right Nasal Fossa (n=19, n=19)', 'categories': [{'measurements': [{'value': '0.961', 'spread': '0.758', 'groupId': 'OG000'}, {'value': '2.792', 'spread': '6.318', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)', 'description': 'Rhinomanometry examination of the left \\& right Nasal Fossa was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4) in participants ages 7-11 years.\n\nRhinomanometry is a test of nasal function that measures air pressure and the rate of airflow in the nasal airway during respiration by means of equipment. These findings were used to calculate expiratory nasal airway resistance reported in Pascal/centimeter\\^3/second (Pa/cm\\^3/sec).', 'unitOfMeasure': 'Pa/cm^3/sec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was only performed in a cohort of the ITT in participants ages 7-11 years old (MFSN=19, Placebo=20).'}, {'type': 'SECONDARY', 'title': 'Rhinomanometry Results- Left and Right Nasal Fossa: Inspiration Flow at 75 Pa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone Furoate Nasal Spray (MFNS)', 'description': '1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).'}, {'id': 'OG001', 'title': 'Placebo Nasal Spray', 'description': '1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).'}], 'classes': [{'title': 'Visit 2- Left Nasal Fossa (n=19, n=20)', 'categories': [{'measurements': [{'value': '200.530', 'spread': '140.492', 'groupId': 'OG000'}, {'value': '178.933', 'spread': '129.272', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3- Left Nasal Fossa (n=18, n=18)', 'categories': [{'measurements': [{'value': '222.152', 'spread': '141.740', 'groupId': 'OG000'}, {'value': '151.268', 'spread': '130.115', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4- Left Nasal Fossa (n=19, n=19)', 'categories': [{'measurements': [{'value': '194.208', 'spread': '100.746', 'groupId': 'OG000'}, {'value': '172.346', 'spread': '102.607', 'groupId': 'OG001'}]}]}, {'title': 'Visit 2- Right Nasal Fossa (n=19, n=20)', 'categories': [{'measurements': [{'value': '183.562', 'spread': '121.780', 'groupId': 'OG000'}, {'value': '161.958', 'spread': '138.673', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3- Right Nasal Fossa (n=18, n=18)', 'categories': [{'measurements': [{'value': '228.661', 'spread': '149.318', 'groupId': 'OG000'}, {'value': '197.266', 'spread': '123.763', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4- Right Nasal Fossa (n=19, n=19)', 'categories': [{'measurements': [{'value': '215.400', 'spread': '157.794', 'groupId': 'OG000'}, {'value': '183.368', 'spread': '117.677', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)', 'description': 'Rhinomanometry examination of the left \\& right Nasal Fossa was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4) in participants ages 7-11 years.\n\nRhinomanometry is a test of nasal function that measures air pressure and the rate of airflow in the nasal airway during respiration by means of equipment. Inspiration flow was calculated at 75 Pa.', 'unitOfMeasure': 'cm^3/sec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was only performed in a cohort of the ITT in participants ages 7-11 years old (MFSN=19, Placebo=20).'}, {'type': 'SECONDARY', 'title': 'Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Flow at 75 Pa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone Furoate Nasal Spray (MFNS)', 'description': '1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).'}, {'id': 'OG001', 'title': 'Placebo Nasal Spray', 'description': '1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).'}], 'classes': [{'title': 'Visit 2- Left Nasal Fossa (n=19, n=20)', 'categories': [{'measurements': [{'value': '190.024', 'spread': '146.067', 'groupId': 'OG000'}, {'value': '166.930', 'spread': '116.802', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3- Left Nasal Fossa (n=18, n=18)', 'categories': [{'measurements': [{'value': '225.911', 'spread': '154.830', 'groupId': 'OG000'}, {'value': '173.139', 'spread': '151.783', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4- Left Nasal Fossa (n=19, n=19)', 'categories': [{'measurements': [{'value': '181.026', 'spread': '119.728', 'groupId': 'OG000'}, {'value': '192.374', 'spread': '134.337', 'groupId': 'OG001'}]}]}, {'title': 'Visit 2- Right Nasal Fossa (n=19, n=20)', 'categories': [{'measurements': [{'value': '160.531', 'spread': '117.988', 'groupId': 'OG000'}, {'value': '166.302', 'spread': '132.754', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3- Right Nasal Fossa (n=18, n=18)', 'categories': [{'measurements': [{'value': '209.676', 'spread': '157.215', 'groupId': 'OG000'}, {'value': '209.787', 'spread': '151.298', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4- Right Nasal Fossa (n=19, n=19)', 'categories': [{'measurements': [{'value': '195.108', 'spread': '163.411', 'groupId': 'OG000'}, {'value': '176.587', 'spread': '111.421', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)', 'description': 'Rhinomanometry examination of the left \\& right Nasal Fossa was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4) in participants ages 7-11 years.\n\nRhinomanometry is a test of nasal function that measures air pressure and the rate of airflow in the nasal airway during respiration by means of equipment. Expiratory flow was calculated at 75 Pa.', 'unitOfMeasure': 'cm^3/sec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was only performed in a cohort of the ITT in participants ages 7-11 years old (MFSN=19, Placebo=20).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Pure-Tone Audiometric Results of: Normal, Abnormal, or Not Done', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone Furoate Nasal Spray (MFNS)', 'description': '1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).'}, {'id': 'OG001', 'title': 'Placebo Nasal Spray', 'description': '1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).'}], 'classes': [{'title': 'Visit 2- Normal (n=19 MFNS, n=21 Placebo)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Visit 2- Abnormal (n=19 MFNS, n=21 Placebo)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Visit 2- Not Done (n=19 MFNS, n= 21 Placebo)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3- Normal (n=20 MFNS, n=21 Placebo)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3- Abnormal (n=20 MFNS, n=21 Placebo)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3- Not Done (n=20 MFNS, n=21 Placebo)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4- Normal (n=19 MFNS, n=20 Placebo)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4- Abnormal (n=19 MFNS, n=20 Placebo)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4- Not Done (n=19 MFNS, n=20 Placebo)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)', 'description': "Pure-tone audiometry was performed in children ages 7-11 by certified audiologists. Results were categorized based on audiologist's assessment as either being normal (within normal limits), abnormal (outside normal limits), or audiometry was not done (not performed). Results were assessed at baseline, Week 4 (Visit 3), and endpoint Week 8 (end of treatment).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was only performed in a cohort of the ITT in participants ages 7-11 years old (MFSN=19, Placebo=20).'}, {'type': 'SECONDARY', 'title': 'Acoustic Rhinometry Results- Minimal Cross-Sectional Area: Left and Right Nasal Fossa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone Furoate Nasal Spray (MFNS)', 'description': '1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).'}, {'id': 'OG001', 'title': 'Placebo Nasal Spray', 'description': '1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).'}], 'classes': [{'title': 'Visit 2- Left Nasal Fossa (n=19, n=20)', 'categories': [{'measurements': [{'value': '0.599', 'spread': '0.567', 'groupId': 'OG000'}, {'value': '0.491', 'spread': '0.265', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3- Left Nasal Fossa (n=18, n=18)', 'categories': [{'measurements': [{'value': '0.608', 'spread': '0.485', 'groupId': 'OG000'}, {'value': '0.594', 'spread': '0.403', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4- Left Nasal Fossa (n=19, n=19)', 'categories': [{'measurements': [{'value': '0.662', 'spread': '0.444', 'groupId': 'OG000'}, {'value': '0.661', 'spread': '0.444', 'groupId': 'OG001'}]}]}, {'title': 'Visit 2- Right Nasal Fossa (n=19, n=20)', 'categories': [{'measurements': [{'value': '0.532', 'spread': '0.467', 'groupId': 'OG000'}, {'value': '0.577', 'spread': '0.381', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3- Right Nasal Fossa (n=18, n=18)', 'categories': [{'measurements': [{'value': '0.581', 'spread': '0.405', 'groupId': 'OG000'}, {'value': '0.596', 'spread': '0.383', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4- Right Nasal Fossa (n=19, n=19)', 'categories': [{'measurements': [{'value': '0.734', 'spread': '0.599', 'groupId': 'OG000'}, {'value': '0.814', 'spread': '0.675', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)', 'description': 'Acoustic rhinometry examination of the left \\& right Nasal Fossa was performed by principal investigators at baseline \\& each visit throughout treatment in participants ages 7-11 years. Acoustic rhinometry is a technique intended for assessment of the geometry of the nasal cavity and nasopharynx and for evaluating nasal obstruction. The technique is based on an analysis of sound waves reflected from the nasal cavities.\n\nMeasurements were taken for each side of the nose (nasopharyngeal minimum cross-sectional area) \\& were reported in cm\\^3.', 'unitOfMeasure': 'cm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was only performed in a cohort of the ITT in participants ages 7-11 years old (MFSN=19, Placebo=20).'}, {'type': 'SECONDARY', 'title': 'Acoustic Rhinometry Results- Nasopharyngeal Volume (NPV): Left and Right Nasal Fossa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone Furoate Nasal Spray (MFNS)', 'description': '1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).'}, {'id': 'OG001', 'title': 'Placebo Nasal Spray', 'description': '1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).'}], 'classes': [{'title': 'Visit 2- Left Nasal Fossa (n=19, n=20)', 'categories': [{'measurements': [{'value': '4.245', 'spread': '1.954', 'groupId': 'OG000'}, {'value': '4.117', 'spread': '3.554', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3- Left Nasal Fossa (n=18, n=18)', 'categories': [{'measurements': [{'value': '3.725', 'spread': '1.944', 'groupId': 'OG000'}, {'value': '3.489', 'spread': '1.589', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4- Left Nasal Fossa (n=19, n=19)', 'categories': [{'measurements': [{'value': '3.631', 'spread': '0.905', 'groupId': 'OG000'}, {'value': '3.084', 'spread': '1.724', 'groupId': 'OG001'}]}]}, {'title': 'Visit 2- Right Nasal Fossa (n=19, n=20)', 'categories': [{'measurements': [{'value': '3.566', 'spread': '1.629', 'groupId': 'OG000'}, {'value': '4.489', 'spread': '2.941', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3- Right Nasal Fossa (n=19, n=18)', 'categories': [{'measurements': [{'value': '4.183', 'spread': '1.341', 'groupId': 'OG000'}, {'value': '4.884', 'spread': '3.591', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4- Right Nasal Fossa (n=19, n=19)', 'categories': [{'measurements': [{'value': '3.774', 'spread': '1.240', 'groupId': 'OG000'}, {'value': '3.275', 'spread': '1.083', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)', 'description': 'Acoustic rhinometry examination of the left \\& right Nasal Fossa was performed by principal investigators at baseline \\& each visit throughout treatment in participants ages 7-11 years. Acoustic rhinometry is a technique intended for assessment of the geometry of the nasal cavity and nasopharynx and for evaluating nasal obstruction. The technique is based on an analysis of sound waves reflected from the nasal cavities.', 'unitOfMeasure': 'cm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was only performed in a cohort of the ITT in participants ages 7-11 years old (MFSN=19, Placebo=20).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Pediatric Sleep Questionnaire (PSQ)- Impact on Health-Related Quality of Life (HRQL) Results of: Mild, Moderate, or Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone Furoate Nasal Spray (MFNS)', 'description': '1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).'}, {'id': 'OG001', 'title': 'Placebo Nasal Spray', 'description': '1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).'}], 'classes': [{'title': 'Visit 2- Mild (n=66 MFNS, n=65 Placebo)', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Visit 2- Moderate (n=66 MFNS, n=65 Placebo)', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Visit 2- Severe (n=66 MFNS, n=65 Placebo)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3- Mild (n=65 MFNS, n=65 Placebo)', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3- Moderate (n=65 MFNS, n=Placebo)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3- Severe (n=65 MFNS, n=65 Placebo)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4- Mild (n=62 MFNS, n=59 Placebo)', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4- Moderate (n=62 MFNS, n=59 Placebo)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4- Severe (n=62 MFNS, n= 59 Placebo)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)', 'description': 'PSQ consists of 90 variables divided into 3 different factors:snoring, somnolence, and behavior. All positive Snoring and Somnolence answers scored with Yes=1 and No=0, and scores averaged to obtain a total score between 0.00 and 1.00. Behavior factor scored between 1-3, and scores averaged for total score of 1 to 3. Increased scores indicate increasing abnormality of sleep. Based on determined cut-offs, participants were categorized as having mild, moderate, or severe discomfort due to interference of sleep.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 132 participants were included in the ITT population. The ITT\n\npopulation included all randomized participants who received at least one dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point.'}, {'type': 'SECONDARY', 'title': 'Quality of Life Questionnaire (PedsQL) Total Score (Ages 2-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone Furoate Nasal Spray (MFNS)', 'description': '1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).'}, {'id': 'OG001', 'title': 'Placebo Nasal Spray', 'description': '1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).'}], 'classes': [{'title': 'Visit 2 (n= 23 MFNS, n=29 Placebo)', 'categories': [{'measurements': [{'value': '78.442', 'spread': '13.114', 'groupId': 'OG000'}, {'value': '78.017', 'spread': '14.769', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3 (n=22 MFNS, n= 28 Placebo)', 'categories': [{'measurements': [{'value': '80.438', 'spread': '15.827', 'groupId': 'OG000'}, {'value': '78.486', 'spread': '15.707', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4 (n=18 MFNS, n=25 Placebo)', 'categories': [{'measurements': [{'value': '80.137', 'spread': '15.161', 'groupId': 'OG000'}, {'value': '82.701', 'spread': '11.911', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)', 'description': "The impact on quality of life (QOL) was measured by a general pediatric health questionnaire. Versions were self-administered \\& answered by participants' parents. This modular instrument consists of 21 items using a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, \\& school functioning) are scored. Total score is sum of all the items over the number of items answered on all the scales. Higher scores indicate a better health related QOL.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all randomized participants who received \\>= 1 dose after commencement of treatment. At baseline (visit 2), 52 randomized participants were between 2 and 4 years old, 23 participants in MFNS \\& 29 participants in Placebo group. Questionnaire was answered in accordance with the actual age of each participant at each visit.'}, {'type': 'SECONDARY', 'title': 'Quality of Life Questionnaire (PedsQL) Total Score (Ages 5-7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone Furoate Nasal Spray (MFNS)', 'description': '1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).'}, {'id': 'OG001', 'title': 'Placebo Nasal Spray', 'description': '1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).'}], 'classes': [{'title': 'Visit 2 (n= 28 MFNS, n=24 Placebo)', 'categories': [{'measurements': [{'value': '78.14', 'spread': '15.74', 'groupId': 'OG000'}, {'value': '79.03', 'spread': '11.35', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3 (n=28 MFNS, n= 23 Placebo)', 'categories': [{'measurements': [{'value': '81.56', 'spread': '13.64', 'groupId': 'OG000'}, {'value': '84.07', 'spread': '12.26', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4 (n=28 MFNS, n=22 Placebo)', 'categories': [{'measurements': [{'value': '83.54', 'spread': '13.63', 'groupId': 'OG000'}, {'value': '82.71', 'spread': '13.52', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)', 'description': "The impact on quality of life (QOL) was measured by a general pediatric health questionnaire. Versions were self-administered \\& answered by participants' parents. Questionnaire consists of 23 items using a 3-point scale: from 0 (not at all), 2 (sometimes), 4 (a lot). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, \\& school functioning) are scored. Total score is sum of all the items over the number of items answered on all the scales. Higher scores indicate a better health related QOL.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all randomized participants who received \\>= 1 dose after commencement of treatment. At baseline (visit 2), 52 randomized participants were between 5 and 7 years old, 28 participants in MFNS \\& 24 subjects in Placebo group. Questionnaire was answered in accordance with the actual age of each participant at each visit.'}, {'type': 'SECONDARY', 'title': 'Quality of Life Questionnaire (PedsQL) Total Score (Ages 8-12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone Furoate Nasal Spray (MFNS)', 'description': '1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).'}, {'id': 'OG001', 'title': 'Placebo Nasal Spray', 'description': '1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).'}], 'classes': [{'title': 'Visit 2 (n= 15 MFNS, n=13 Placebo)', 'categories': [{'measurements': [{'value': '76.014', 'spread': '10.266', 'groupId': 'OG000'}, {'value': '76.839', 'spread': '10.828', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3 (n=15 MFNS, n= 14 Placebo)', 'categories': [{'measurements': [{'value': '82.971', 'spread': '15.054', 'groupId': 'OG000'}, {'value': '84.006', 'spread': '14.033', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4 (n=15 MFNS, n=13 Placebo)', 'categories': [{'measurements': [{'value': '85.725', 'spread': '12.033', 'groupId': 'OG000'}, {'value': '83.946', 'spread': '10.023', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)', 'description': "The impact on quality of life (QOL) was measured by a general pediatric health questionnaire. Versions were self-administered \\& answered by participants' parents. This modular instrument consists of 23 items using a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, \\& school functioning) are scored. Total score is sum of all the items over the number of items answered on all the scales. Higher scores indicate a better health related QOL.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all randomized participants who received \\>= 1 dose after commencement of treatment. At baseline (visit 2), 28 randomized participants were between 8-12 years old, 15 participants in MFNS \\& 13 participants in Placebo group. Questionnaire was answered in accordance with the actual age of each participant at each visit.'}, {'type': 'SECONDARY', 'title': 'Obstructive Sleep Apnea-18 (OSA-18) Questionnaire Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mometasone Furoate Nasal Spray (MFNS)', 'description': '1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).'}, {'id': 'OG001', 'title': 'Placebo Nasal Spray', 'description': '1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).'}], 'classes': [{'title': 'Visit 2 (n=66 MFNS, n=65 Placebo)', 'categories': [{'measurements': [{'value': '62.742', 'spread': '19.951', 'groupId': 'OG000'}, {'value': '60.169', 'spread': '19.123', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3 (n=65 MFNS, n= 65 Placebo)', 'categories': [{'measurements': [{'value': '47.138', 'spread': '18.806', 'groupId': 'OG000'}, {'value': '48.769', 'spread': '18.748', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4 (n=62 MFNS, n= 59 Placebo)', 'categories': [{'measurements': [{'value': '42.742', 'spread': '17.880', 'groupId': 'OG000'}, {'value': '43.068', 'spread': '18.870', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)', 'description': '18 items of the survey were graded on a 7-point ordinal scale. Caregivers were asked to describe how often in the last 4 weeks had the child exhibited specific symptoms according to the following scale: 1: none of the time; 2: hardly any of the time; 3: a little of the time; 4: some of the time; 5: a good bit of the time; 6: most of the time; 7: all of the time. All scores were summed (total score: 18-126).\n\nGrading was as follows:\n\n* Scores \\< 60 suggest a slight impact on health related quality of life (HRQL)\n* Scores 60-80 suggest a moderate impact\n* Scores over 80 suggest a great impact', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 132 subjects were included in the ITT population. The ITT population included all randomized participants who received \\>=1 dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point.\n\n1 participant in Placebo group did not answer this questionnaire at baseline.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mometasone Furoate Nasal Spray', 'description': '1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).'}, {'id': 'FG001', 'title': 'Placebo Nasal Spray', 'description': '1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '66'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '19'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'preAssignmentDetails': '135 participants were screened, a total of 132 participants were randomized to receive either Mometasone furoate nasal spray (MFNS) (n=66) or placebo nasal spray (n=66).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Mometasone Furoate Nasal Spray', 'description': '1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).'}, {'id': 'BG001', 'title': 'Placebo Nasal Spray', 'description': '1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '5.56', 'spread': '2.27', 'groupId': 'BG000'}, {'value': '5.36', 'spread': '2.50', 'groupId': 'BG001'}, {'value': '5.46', 'spread': '2.38', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'dispFirstSubmitDate': '2011-01-13', 'completionDateStruct': {'date': '2010-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-08', 'studyFirstSubmitDate': '2007-10-31', 'dispFirstSubmitQcDate': '2011-01-13', 'resultsFirstSubmitDate': '2011-12-22', 'studyFirstSubmitQcDate': '2007-10-31', 'dispFirstPostDateStruct': {'date': '2011-02-03', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2024-05-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-12-22', 'studyFirstPostDateStruct': {'date': '2007-11-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Adenoid/Choana (A/C) Index Grade', 'timeFrame': 'Baseline (visit 2), Weeks 4 (visit 3), Week 8 (visit 4)', 'description': 'Changes in adenoid size were assessed by nasopharyngoscopic examination and were determined using the Adenoid/Choana (A/C) Index. Grades were assigned to intervals of A/C ratio percentages: grade I (0-25%), II (26-50%), III (51-75%) and IV (76-100%). Changes in adenoid size were expressed as the mean difference between grades at baseline and study visit. Positive values indicated a decrease in adenoid size, a 0 value indicated that size remained the same, and negative values indicated an increase in adenoid size.'}], 'secondaryOutcomes': [{'measure': 'Total Severity Symptom Scores: Morning and Evening (AM & PM)', 'timeFrame': 'Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)', 'description': 'Symptoms were assessed by whole-number linear scale to grade their severity. Scores were recorded AM \\& PM (a difference of 12 hours) \\& were based on severity within 12 hours of prior recording. The following symptoms were evaluated: Snoring; Nasal obstruction \\& discharge; Breathing difficulty; Oral respiration; Ear pain. Severity was graded according to the following scale: 0=absent; 1=mild; 2=moderate; 3=severe. Severity was scored individually and summed to obtain the Total Symptom Severity Score. The maximum total score possible was 36 daily; 18 for both AM (6 symptoms times max severity of 3)and PM.'}, {'measure': 'Total Frequency Symptom Scores: AM & PM', 'timeFrame': 'Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)', 'description': 'Symptoms were assessed by whole-number linear scale to grade their frequency. Scores were recorded AM \\& PM (a difference of 12 hours) \\& were based on frequency within 12 hours of prior recording. The following signs/symptoms were evaluated: Snoring; Nasal obstruction; and nasal discharge; Breathing difficulty; Oral respiration; Ear pain. Frequency was graded according to the following scale: 0=absent; 1=intermittent; 2=persistent. The frequency of symptoms was scored individually and summed to obtain the Total Frequency Symptom Score. The maximum total score possible was 24 daily; 12 for both AM (6 symptoms times max frequency of 2) and PM.'}, {'measure': 'Number of Participants With Bilateral Tympanogram Results of: Normal, Abnormal, or Not Done', 'timeFrame': 'Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)', 'description': "Tympanometry was performed in children ages 2-11 by certified audiologists. Results were categorized based on audiologist's assessment as either being normal (normal pressure in the middle ear with normal mobility of the eardrum and the conduction bones) , abnormal (abnormal pressure in the middle ear and/or abnormal mobility of the eardrum and the conduction bones), or tympanometry was not done (evaluation not completed). Results were assessed at baseline, Week 4 (Visit 3), and endpoint Week 8 (end of treatment)."}, {'measure': 'Number of Participants With Otoscopic Results of: Normal or Abnormal', 'timeFrame': 'Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)', 'description': "Otoscopic examination was performed of the right and left ear canals at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4). Results were categorized based on audiologist's assessment as either being normal (ear canal structures appear normal) or abnormal (ear canal structures appear abnormal)."}, {'measure': 'Number of Participants With Rhinoscopic- Septum Results of: Aligned, Non-Obstructive, or Obstructive Deviation', 'timeFrame': 'Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)', 'description': "Rhinoscopic examination of the septum was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4). Results were categorized based on investigator's assessment as either being aligned (septum is aligned), non-obstructive (septum is not aligned but the deviation is non-obstructive), or obstructive (septum is deviated and obstructive) deviation."}, {'measure': 'Number of Participants With Rhinoscopic-Inferior Turbinates Results of: Normal, Hypertrophic, and Hypotrophic', 'timeFrame': 'Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)', 'description': "Rhinoscopic examination of the inferior turbinates was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4). Results were categorized based on investigator's assessment as either being normal appearance (normal size) , hypertrophic (swollen/normal size increased), or hypotrophic (normal size diminished)."}, {'measure': 'Number of Participants With Rhinoscopic- Middle Meatus Results of: Patent, Partial Obstruction or Total Obstruction', 'timeFrame': 'Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)', 'description': "Rhinoscopic examination of the middle meatus was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4). Results were categorized based on investigator's assessment into 3 categories: patent (easily observed), partial obstruction (partially blocked from view), or total obstruction (completely blocked from view)."}, {'measure': 'Rhinomanometry Results- Left and Right Nasal Fossa: Inspiratory Resistance', 'timeFrame': 'Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)', 'description': 'Rhinomanometry examination of the left \\& right Nasal Fossa was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4) in participants ages 7-11 years.\n\nRhinomanometry is a test of nasal function that measures air pressure and the rate of airflow in the nasal airway during respiration by means of equipment. These findings were used to calculate inspiratory nasal airway resistance reported in Pascal/centimeter\\^3/second (Pa/cm\\^3/sec).'}, {'measure': 'Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Resistance', 'timeFrame': 'Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)', 'description': 'Rhinomanometry examination of the left \\& right Nasal Fossa was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4) in participants ages 7-11 years.\n\nRhinomanometry is a test of nasal function that measures air pressure and the rate of airflow in the nasal airway during respiration by means of equipment. These findings were used to calculate expiratory nasal airway resistance reported in Pascal/centimeter\\^3/second (Pa/cm\\^3/sec).'}, {'measure': 'Rhinomanometry Results- Left and Right Nasal Fossa: Inspiration Flow at 75 Pa', 'timeFrame': 'Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)', 'description': 'Rhinomanometry examination of the left \\& right Nasal Fossa was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4) in participants ages 7-11 years.\n\nRhinomanometry is a test of nasal function that measures air pressure and the rate of airflow in the nasal airway during respiration by means of equipment. Inspiration flow was calculated at 75 Pa.'}, {'measure': 'Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Flow at 75 Pa', 'timeFrame': 'Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)', 'description': 'Rhinomanometry examination of the left \\& right Nasal Fossa was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4) in participants ages 7-11 years.\n\nRhinomanometry is a test of nasal function that measures air pressure and the rate of airflow in the nasal airway during respiration by means of equipment. Expiratory flow was calculated at 75 Pa.'}, {'measure': 'Number of Participants With Pure-Tone Audiometric Results of: Normal, Abnormal, or Not Done', 'timeFrame': 'Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)', 'description': "Pure-tone audiometry was performed in children ages 7-11 by certified audiologists. Results were categorized based on audiologist's assessment as either being normal (within normal limits), abnormal (outside normal limits), or audiometry was not done (not performed). Results were assessed at baseline, Week 4 (Visit 3), and endpoint Week 8 (end of treatment)."}, {'measure': 'Acoustic Rhinometry Results- Minimal Cross-Sectional Area: Left and Right Nasal Fossa', 'timeFrame': 'Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)', 'description': 'Acoustic rhinometry examination of the left \\& right Nasal Fossa was performed by principal investigators at baseline \\& each visit throughout treatment in participants ages 7-11 years. Acoustic rhinometry is a technique intended for assessment of the geometry of the nasal cavity and nasopharynx and for evaluating nasal obstruction. The technique is based on an analysis of sound waves reflected from the nasal cavities.\n\nMeasurements were taken for each side of the nose (nasopharyngeal minimum cross-sectional area) \\& were reported in cm\\^3.'}, {'measure': 'Acoustic Rhinometry Results- Nasopharyngeal Volume (NPV): Left and Right Nasal Fossa', 'timeFrame': 'Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)', 'description': 'Acoustic rhinometry examination of the left \\& right Nasal Fossa was performed by principal investigators at baseline \\& each visit throughout treatment in participants ages 7-11 years. Acoustic rhinometry is a technique intended for assessment of the geometry of the nasal cavity and nasopharynx and for evaluating nasal obstruction. The technique is based on an analysis of sound waves reflected from the nasal cavities.'}, {'measure': 'Number of Participants With Pediatric Sleep Questionnaire (PSQ)- Impact on Health-Related Quality of Life (HRQL) Results of: Mild, Moderate, or Severe', 'timeFrame': 'Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)', 'description': 'PSQ consists of 90 variables divided into 3 different factors:snoring, somnolence, and behavior. All positive Snoring and Somnolence answers scored with Yes=1 and No=0, and scores averaged to obtain a total score between 0.00 and 1.00. Behavior factor scored between 1-3, and scores averaged for total score of 1 to 3. Increased scores indicate increasing abnormality of sleep. Based on determined cut-offs, participants were categorized as having mild, moderate, or severe discomfort due to interference of sleep.'}, {'measure': 'Quality of Life Questionnaire (PedsQL) Total Score (Ages 2-4)', 'timeFrame': 'Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)', 'description': "The impact on quality of life (QOL) was measured by a general pediatric health questionnaire. Versions were self-administered \\& answered by participants' parents. This modular instrument consists of 21 items using a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, \\& school functioning) are scored. Total score is sum of all the items over the number of items answered on all the scales. Higher scores indicate a better health related QOL."}, {'measure': 'Quality of Life Questionnaire (PedsQL) Total Score (Ages 5-7)', 'timeFrame': 'Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)', 'description': "The impact on quality of life (QOL) was measured by a general pediatric health questionnaire. Versions were self-administered \\& answered by participants' parents. Questionnaire consists of 23 items using a 3-point scale: from 0 (not at all), 2 (sometimes), 4 (a lot). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, \\& school functioning) are scored. Total score is sum of all the items over the number of items answered on all the scales. Higher scores indicate a better health related QOL."}, {'measure': 'Quality of Life Questionnaire (PedsQL) Total Score (Ages 8-12)', 'timeFrame': 'Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)', 'description': "The impact on quality of life (QOL) was measured by a general pediatric health questionnaire. Versions were self-administered \\& answered by participants' parents. This modular instrument consists of 23 items using a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, \\& school functioning) are scored. Total score is sum of all the items over the number of items answered on all the scales. Higher scores indicate a better health related QOL."}, {'measure': 'Obstructive Sleep Apnea-18 (OSA-18) Questionnaire Total Score', 'timeFrame': 'Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)', 'description': '18 items of the survey were graded on a 7-point ordinal scale. Caregivers were asked to describe how often in the last 4 weeks had the child exhibited specific symptoms according to the following scale: 1: none of the time; 2: hardly any of the time; 3: a little of the time; 4: some of the time; 5: a good bit of the time; 6: most of the time; 7: all of the time. All scores were summed (total score: 18-126).\n\nGrading was as follows:\n\n* Scores \\< 60 suggest a slight impact on health related quality of life (HRQL)\n* Scores 60-80 suggest a moderate impact\n* Scores over 80 suggest a great impact'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Adenoids Hypertrophy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether 8 weeks treatment with mometasone furoate nasal spray (MFNS), twice daily, is safe and effective in treating adenoid hypertrophy in children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants and their parents must demonstrate willingness to participate and comply with study procedures. Parents must sign a written informed consent\n* Participants and their parents must understand and be able to adhere to dosing and visit schedules, and agree to record symptom severity scores, medication times, and concomitant medications accurately and consistently in a daily diary\n* Children with a history of adenoid hypertrophy for at least 3 months with no response to previous medical treatment\n* Baseline adenoid tissue size must have been graded by nasopharyngoscopy examination as Grade III or IV on the Adenoid/Choana (A/C) Index (between 50% and 100% obstruction)\n* Baseline Total Severity Symptoms Score must be ≥ 8 points (AM or PM)\n* For inclusion in endpoints relating to otitis media with effusion (OME), participant must have persistent middle ear effusion for the past 3 months or more documented by otoscopic examination, middle ear pressure less than -150 mm H2O, Jerger type B flat tympanogram, and mild-moderate conductive hearing loss in audiometry supporting the diagnosis of OME\n\nExclusion Criteria:\n\n* Participants with previous surgery of hypertrophic adenoids with or without tympanostomy tube placement\n* Participants treated with inhaled or systemic corticosteroids within the past 1 month\n* Participants with Morbid Obesity (Body Mass Index \\>95 percentile of charts from the Centers for Disease Control)\n* Participants who have not accomplished the designated washout periods for any of the prohibited medications\n* Participants who have used any investigational products within the last 30 days\n* Participants who have used any antibodies for allergies in the past 90 days\n* Participants who have any abnormal physical examination results that may affect study evaluations or participant safety in the investigator's judgment\n* Participants who are allergic or have an idiosyncratic reaction to corticosteroids\n* Participants with signs and symptoms of acute or chronic bacterial rhinosinusitis\n* Participants has had an upper or lower respiratory tract or sinus infection that required antibiotic therapy with the last dose later than 14 days prior to screening, or who has had a viral upper or lower respiratory infection within 7 days prior to screening\n* Participants with a documented immunodeficiency condition\n* Participants with nasal structural abnormalities, including large nasal polyps and marked septum deviation that significantly interferes with nasal airflow\n* Participants with any clinically significant metabolic, cardiovascular, neurologic, hematologic, gastrointestinal, cerebrovascular, or respiratory disease (other than asthma), or any other disorder which, in the judgment of the Investigator, may interfere with the study evaluations or affect participant safety"}, 'identificationModule': {'nctId': 'NCT00552032', 'acronym': 'SNORE', 'briefTitle': 'Efficacy and Safety of Mometasone Furoate Nasal Spray in Children With Adenoid Hypertrophy. SNORE Study (P05155)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'A Double-blind Placebo-controlled, Randomized, Parallel-group, Multicenter Clinical Trial to Evaluate Efficacy and Safety of Mometasone Furoate Nasal Spray in Children With Adenoid Hypertrophy SNORE Study', 'orgStudyIdInfo': {'id': 'P05155'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mometasone Furoate nasal spray', 'interventionNames': ['Drug: Mometasone Furoate nasal spray']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Mometasone Furoate nasal spray', 'type': 'DRUG', 'otherNames': ['SCH 032088'], 'description': 'Mometasone Furoate nasal spray 1 puff (50 mcg) per nostril twice daily x 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).', 'armGroupLabels': ['Mometasone Furoate nasal spray']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo nasal spray 1 puff per nostril twice daily x 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).', 'armGroupLabels': ['Placebo']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}