Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-01-07 @ 8:37 AM
Study NCT ID:
NCT01067105
Status:
COMPLETED
Last Update Posted:
2012-06-13
First Post:
2010-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A 6 Month Study of Once Daily Ciclesonide Hydrofluoroalkane (HFA) Nasal Aerosol in The Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012221', 'term': 'Rhinitis, Allergic, Perennial'}, {'id': 'D065631', 'term': 'Rhinitis, Allergic'}], 'ancestors': [{'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '1-866-503-6351', 'title': 'Respiratory Medical Director', 'organization': 'Sunovion'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Open label study investigating a dose higher than the US FDA approved dose (74 mcg once daily) for allergic rhinitis subjects. Publication references to 148 mcg is equivalent to 160 mcg.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Ciclesonide', 'description': 'ciclesonide HFA 160 μg once daily', 'otherNumAtRisk': 824, 'otherNumAffected': 329, 'seriousNumAtRisk': 824, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 824, 'numEvents': 24, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 824, 'numEvents': 35, 'numAffected': 31}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 824, 'numEvents': 42, 'numAffected': 38}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 824, 'numEvents': 72, 'numAffected': 61}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 824, 'numEvents': 23, 'numAffected': 22}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 824, 'numEvents': 20, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 824, 'numEvents': 23, 'numAffected': 21}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 824, 'numEvents': 56, 'numAffected': 39}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 824, 'numEvents': 64, 'numAffected': 46}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Nasal septum disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 824, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 824, 'numEvents': 21, 'numAffected': 20}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'seriousEvents': [{'term': 'Artrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 824, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 824, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 824, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 824, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 824, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 824, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 824, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 824, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 824, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Renal injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 824, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 824, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 824, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Troponin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 824, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Breast cancer stage II', 'stats': [{'groupId': 'EG000', 'numAtRisk': 824, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 824, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Ectopic pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 824, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Mental status change', 'stats': [{'groupId': 'EG000', 'numAtRisk': 824, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Endometrial hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 824, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 824, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 824, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 824, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Imprisonment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 824, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects Experiencing Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '824', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciclesonide', 'description': 'ciclesonide HFA 160 μg once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '51.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 1-26', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population'}, {'type': 'PRIMARY', 'title': 'Percentage of Subjects Experiencing Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '824', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciclesonide', 'description': 'ciclesonide HFA 160 μg once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 1-26', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population'}, {'type': 'PRIMARY', 'title': 'Percentage of Subjects Who Discontinue Due to AEs.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '824', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciclesonide', 'description': 'ciclesonide HFA 160 μg once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 1-26', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Experiencing Local Nasal AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '824', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciclesonide', 'description': 'ciclesonide HFA 160 μg once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '29.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 1-26', 'description': 'Local Nasal adverse events are defined as adverse events occurring in the middle ear, nose, throat, and upper respiratory tract down to the larynx, anatomic regions.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 6-month Treatment Period.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '823', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciclesonide', 'description': 'ciclesonide HFA 160 μg once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.50', 'spread': '1.46', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 1-26', 'description': 'TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:\n\n0 = absent\n\n1. = mild\n2. = moderate\n3. = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the 6-month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population. Subjects with missing date were not included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 6-month Treatment Period.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '823', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciclesonide', 'description': 'ciclesonide HFA 160 μg once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.54', 'spread': '1.37', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 1-26', 'description': 'TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:\n\n0 = absent\n\n1. = mild\n2. = moderate\n3. = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population. Subjects with missing date were not included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Daily Subject-reported AM Reflective TNSS at Each Month Over the 6-month Treatment Period.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '823', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciclesonide', 'description': 'ciclesonide HFA 160 μg once daily'}], 'classes': [{'title': 'Month 1 (n=823)', 'categories': [{'measurements': [{'value': '-0.18', 'spread': '1.26', 'groupId': 'OG000'}]}]}, {'title': 'Month 2 (n=806)', 'categories': [{'measurements': [{'value': '-0.48', 'spread': '1.49', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 (n=768)', 'categories': [{'measurements': [{'value': '-0.64', 'spread': '1.57', 'groupId': 'OG000'}]}]}, {'title': 'Month 4 (n=743)', 'categories': [{'measurements': [{'value': '-0.69', 'spread': '1.70', 'groupId': 'OG000'}]}]}, {'title': 'Month 5 (n=716)', 'categories': [{'measurements': [{'value': '-0.64', 'spread': '1.77', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=697)', 'categories': [{'measurements': [{'value': '-0.54', 'spread': '1.87', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Months 1, 2, 3, 4, 5, and 6', 'description': 'TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:\n\n0 = absent\n\n1. = mild\n2. = moderate\n3. = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population. Subjects with missing date were not included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Daily Subject-reported AM Instantaneous TNSS at Each Month Over the 6-month Treatment Period.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '823', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciclesonide', 'description': 'ciclesonide HFA 160 μg once daily'}], 'classes': [{'title': 'Month 1 (n=823)', 'categories': [{'measurements': [{'value': '-0.26', 'spread': '1.16', 'groupId': 'OG000'}]}]}, {'title': 'Month 2 (n=806)', 'categories': [{'measurements': [{'value': '-0.55', 'spread': '1.41', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 (n=768)', 'categories': [{'measurements': [{'value': '-0.66', 'spread': '1.47', 'groupId': 'OG000'}]}]}, {'title': 'Month 4 (n=743)', 'categories': [{'measurements': [{'value': '-0.70', 'spread': '1.57', 'groupId': 'OG000'}]}]}, {'title': 'Month 5 (n=716)', 'categories': [{'measurements': [{'value': '-0.67', 'spread': '1.68', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=697)', 'categories': [{'measurements': [{'value': '-0.57', 'spread': '1.73', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Months 1, 2, 3, 4, 5, 6', 'description': 'TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:\n\n0 = absent\n\n1. = mild\n2. = moderate\n3. = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population. Subjects with missing date were not included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Ratio (Reported as Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances', 'denoms': [{'units': 'Participants', 'counts': [{'value': '824', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciclesonide', 'description': 'ciclesonide HFA 160 μg once daily'}], 'classes': [{'title': 'Week 0-6 (n=778)', 'categories': [{'measurements': [{'value': '112.29', 'spread': '23.64', 'groupId': 'OG000'}]}]}, {'title': 'Week 6-12 (n=732)', 'categories': [{'measurements': [{'value': '112.23', 'spread': '23.72', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0-12', 'description': 'Ratio of correct advance is defined as the (number of doses actuated/number of doses reported) \\* 100% and therefore reported as a percentage.', 'unitOfMeasure': 'percentage of correct advances', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population. Subjects with missing dosing indicator data were excluded from these analyses.'}, {'type': 'SECONDARY', 'title': 'Number of Devices With Actuation Consistency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '824', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciclesonide', 'description': 'ciclesonide HFA 160 μg once daily'}], 'classes': [{'title': 'Week 0-6', 'categories': [{'measurements': [{'value': '556', 'groupId': 'OG000'}]}]}, {'title': 'Week 6-12', 'categories': [{'measurements': [{'value': '531', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-6 and 6-12', 'description': 'Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration', 'unitOfMeasure': 'devices', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Devices With Actuation Consistency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '824', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciclesonide', 'description': 'ciclesonide HFA 160 μg once daily'}], 'classes': [{'title': 'Week 0-6', 'categories': [{'measurements': [{'value': '71.5', 'groupId': 'OG000'}]}]}, {'title': 'Week 6-12', 'categories': [{'measurements': [{'value': '72.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-6 and 6-12', 'description': 'Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration', 'unitOfMeasure': 'percentage of devices', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population'}, {'type': 'SECONDARY', 'title': 'Number of Devices With Major Discrepancies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '824', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciclesonide', 'description': 'ciclesonide HFA 160 μg once daily'}], 'classes': [{'title': 'Week 0-6', 'categories': [{'measurements': [{'value': '144', 'groupId': 'OG000'}]}]}, {'title': 'Week 6-12', 'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-6 and 6-12', 'description': 'A major discrepancy is defined as a discrepancy of \\>20 actuations between the dose indicator and subject self report of study medication administration', 'unitOfMeasure': 'devices', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population'}, {'type': 'SECONDARY', 'title': 'Percentage of Devices With Major Discrepancies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '824', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciclesonide', 'description': 'ciclesonide HFA 160 μg once daily'}], 'classes': [{'title': 'Week 0-6', 'categories': [{'measurements': [{'value': '18.5', 'groupId': 'OG000'}]}]}, {'title': 'Week 6-12', 'categories': [{'measurements': [{'value': '16.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-6 and 6-12', 'description': 'A major discrepancy is defined as a discrepancy of \\>20 actuations between the dose indicator and subject self report of study medication administration', 'unitOfMeasure': 'percentage of devices', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Responding to the Subject Satisfaction Dose Indicator Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '824', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciclesonide', 'description': 'ciclesonide HFA 160 μg once daily'}], 'classes': [{'title': 'Week 6', 'categories': [{'measurements': [{'value': '794', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '744', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 6 and 12', 'description': 'Participants responding to a survey that consisted of 7 questions assessing subject satisfaction with the dose indicator.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ciclesonide', 'description': 'ciclesonide HFA 160 μg once daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '824'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '683'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '141'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '48'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '36'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '31'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '824', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Ciclesonide', 'description': 'ciclesonide HFA 160 μg once daily'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '64', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '743', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.5', 'spread': '13.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '529', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '295', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '160', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '664', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity', 'classes': [{'title': 'White/Caucasian', 'categories': [{'measurements': [{'value': '690', 'groupId': 'BG000'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '104', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'Multiple', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline AM Reflective Total Nasal Symptom Score (rTNSS)', 'classes': [{'categories': [{'measurements': [{'value': '5.66', 'spread': '3.07', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:\n\n0 = absent\n\n1. = mild\n2. = moderate\n3. = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline AM Instantaneous Total Nasal Symptom Score (iTNSS)', 'classes': [{'categories': [{'measurements': [{'value': '5.12', 'spread': '3.05', 'groupId': 'BG000'}]}]}], 'paramType': 'MEDIAN', 'description': 'TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:\n\n0 = absent\n\n1. = mild\n2. = moderate\n3. = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Baseline was the average of the AM and PM responses obtained during the run-in period up to 6 days prior to randomization.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 824}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'dispFirstSubmitDate': '2011-11-08', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-08', 'studyFirstSubmitDate': '2010-02-09', 'dispFirstSubmitQcDate': '2011-11-08', 'resultsFirstSubmitDate': '2012-02-15', 'studyFirstSubmitQcDate': '2010-02-09', 'dispFirstPostDateStruct': {'date': '2011-11-16', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2012-06-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-05-07', 'studyFirstPostDateStruct': {'date': '2010-02-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects Experiencing Adverse Events (AEs)', 'timeFrame': 'Weeks 1-26'}, {'measure': 'Percentage of Subjects Experiencing Serious Adverse Events (SAEs)', 'timeFrame': 'Weeks 1-26'}, {'measure': 'Percentage of Subjects Who Discontinue Due to AEs.', 'timeFrame': 'Weeks 1-26'}], 'secondaryOutcomes': [{'measure': 'Percentage of Subjects Experiencing Local Nasal AEs', 'timeFrame': 'Weeks 1-26', 'description': 'Local Nasal adverse events are defined as adverse events occurring in the middle ear, nose, throat, and upper respiratory tract down to the larynx, anatomic regions.'}, {'measure': 'Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 6-month Treatment Period.', 'timeFrame': 'Baseline and Weeks 1-26', 'description': 'TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:\n\n0 = absent\n\n1. = mild\n2. = moderate\n3. = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the 6-month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.'}, {'measure': 'Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 6-month Treatment Period.', 'timeFrame': 'Baseline and Weeks 1-26', 'description': 'TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:\n\n0 = absent\n\n1. = mild\n2. = moderate\n3. = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.'}, {'measure': 'Change From Baseline in Daily Subject-reported AM Reflective TNSS at Each Month Over the 6-month Treatment Period.', 'timeFrame': 'Baseline and Months 1, 2, 3, 4, 5, and 6', 'description': 'TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:\n\n0 = absent\n\n1. = mild\n2. = moderate\n3. = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.'}, {'measure': 'Change From Baseline in Daily Subject-reported AM Instantaneous TNSS at Each Month Over the 6-month Treatment Period.', 'timeFrame': 'Baseline and Months 1, 2, 3, 4, 5, 6', 'description': 'TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where:\n\n0 = absent\n\n1. = mild\n2. = moderate\n3. = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the month treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.'}, {'measure': 'Ratio (Reported as Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances', 'timeFrame': 'Weeks 0-12', 'description': 'Ratio of correct advance is defined as the (number of doses actuated/number of doses reported) \\* 100% and therefore reported as a percentage.'}, {'measure': 'Number of Devices With Actuation Consistency', 'timeFrame': 'Weeks 0-6 and 6-12', 'description': 'Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration'}, {'measure': 'Percentage of Devices With Actuation Consistency', 'timeFrame': 'Weeks 0-6 and 6-12', 'description': 'Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration'}, {'measure': 'Number of Devices With Major Discrepancies', 'timeFrame': 'Weeks 0-6 and 6-12', 'description': 'A major discrepancy is defined as a discrepancy of \\>20 actuations between the dose indicator and subject self report of study medication administration'}, {'measure': 'Percentage of Devices With Major Discrepancies', 'timeFrame': 'Weeks 0-6 and 6-12', 'description': 'A major discrepancy is defined as a discrepancy of \\>20 actuations between the dose indicator and subject self report of study medication administration'}, {'measure': 'Number of Subjects Responding to the Subject Satisfaction Dose Indicator Survey', 'timeFrame': 'Weeks 6 and 12', 'description': 'Participants responding to a survey that consisted of 7 questions assessing subject satisfaction with the dose indicator.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Perennial allergic rhinitis', 'allergic rhinitis', 'ciclesonide'], 'conditions': ['Perennial Allergic Rhinitis']}, 'descriptionModule': {'briefSummary': '6-month safety extension study in subjects who have completed Study 060-633 (NCT00953147). Evaluating the long-term safety of ciclesonide HFA nasal aerosol 160 μg administered once-daily in patients with Perennial Allergic Rhinitis.', 'detailedDescription': "This is a 6-month multi-center, open-label, long-term safety extension study in subjects who have completed Study 060-633 (NCT00953147). This study is designed to evaluate the long-term safety of ciclesonide HFA nasal aerosol 160 μg administered once-daily to male and female subjects 12 years or older diagnosed with perennial allergic rhinitis (PAR). This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject has successfully completed all visits of Study 060-633.\n* Subject has given written informed consent and assent, including privacy authorization as well as adherence to concomitant medication withholding periods, prior to participation.\n* Subject is male or female 12 years and older.\n* Subject must be in general good health (defined as the absence of any clinically relevant abnormalities as determined by the Investigator) based on screening physical examination, clinical laboratory tests, and medical history.\n* Subject, if female 65 years of age or younger, must have a negative urine pregnancy test (performed at Visit 1). Females of childbearing potential must be instructed to and agree to avoid pregnancy during the study and must use an acceptable method of birth control:\n\n 1. An oral contraceptive, an intrauterine device (IUD), implantable contraceptive, transdermal or injectable contraceptive for at least 1 month prior to entering the study with continued use throughout the study and for thirty days following study participation.\n 2. Barrier method of contraception, eg, condom and/or diaphragm with spermicide while participating in the study.\n 3. Abstinence.\n\nExclusion Criteria:\n\n* Female subject who is pregnant or lactating.\n* History of physical findings of nasal pathology, including nasal polyps.\n* Subject has any condition that, in the judgment of the investigator, would preclude the subject from completing the study.'}, 'identificationModule': {'nctId': 'NCT01067105', 'briefTitle': 'A 6 Month Study of Once Daily Ciclesonide Hydrofluoroalkane (HFA) Nasal Aerosol in The Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sumitomo Pharma America, Inc.'}, 'officialTitle': 'A 6-Month Open-Label, Long-Term Safety Extension Study of Once Daily Ciclesonide HFA Nasal Aerosol (160 μg) in The Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and Older', 'orgStudyIdInfo': {'id': '060-635'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ciclesonide', 'description': 'ciclesonide HFA 160 μg once daily', 'interventionNames': ['Drug: ciclesonide HFA 160 μg']}], 'interventions': [{'name': 'ciclesonide HFA 160 μg', 'type': 'DRUG', 'description': 'ciclesonide HFA 160 μg once daily', 'armGroupLabels': ['ciclesonide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92647', 'city': 'Huntington Beach', 'state': 'California', 'country': 'United States', 'facility': 'Allergy and Asthma Specialists Group', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'zip': '90025', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'California Allergy and Asthma Medical Group', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92691', 'city': 'Mission Viejo', 'state': 'California', 'country': 'United States', 'facility': 'Southern California Research', 'geoPoint': {'lat': 33.60002, 'lon': -117.672}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'CHOC PSF, AMC, Division of Allergy Asthma and Immunology', 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'state': 'South Carolina', 'country': 'United States', 'facility': 'National Allergy, Asthma, and Urticaria Centers', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'ISIS Clinical Research', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Sirius Clinical Research', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78006', 'city': 'Boerne', 'state': 'Texas', 'country': 'United States', 'facility': 'TTS Research', 'geoPoint': {'lat': 29.79466, 'lon': -98.73197}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Pharmaceutical Research and Consulting', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '76132', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'North Texas Institute for Clinical Trials', 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