Ignite Creation Date:
2025-12-24 @ 4:06 PM
Ignite Modification Date:
2026-02-25 @ 6:30 PM
Study NCT ID:
NCT00999466
Status:
COMPLETED
Last Update Posted:
2016-02-26
First Post:
2009-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Tolerability and Effects of AZD8848 in Allergic Asthma Subjects Challenged With Inhaled Allergen
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000609563', 'term': 'AZD8848'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aztrial_results_posting@astrazeneca.com', 'title': 'Gerard Lynch', 'organization': 'AstraZeneca'}, 'certainAgreement': {'otherDetails': "There is an agreement between PI and Sponsor (AZ) or its agents that restricts the PI's right to discuss/publish trial results after the trial is completed. The PI agrees to collaborate in good faith with AZ with regards to content and formation of any publication or disclosure to be made by PI and to pay due consideration to opinions offered by AZ", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'AZD8848, 30 μg', 'description': 'AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.', 'otherNumAffected': 6, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'AZD8848, 60 μg', 'description': 'AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.', 'otherNumAffected': 22, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.', 'otherNumAffected': 24, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'TINNITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Eye Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'LACRIMATION INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'EYE SWELLING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'GLOSSODYNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'SWOLLEN TONGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'CHEST DISCOMFORT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'ALLERGY TO ARTHROPOD BITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'NASAL VESTIBULITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'RHINITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'FACE INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'DYSGEUSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'LETHARGY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'SPUTUM DISCOLOURED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'NASAL INFLAMMATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'NASAL MUCOSAL DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'NASAL SEPTUM ULCERATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'UPPER AIRWAY OBSTRUCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'NASAL DISCOMFORT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'WHEEZING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'THROAT IRRITATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'RHINORRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 28, 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Bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'FEV1, Late Asthmatic Response (LAR) - Pre-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD8848, 30 μg', 'description': 'AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.'}, {'id': 'OG001', 'title': 'AZD8848, 60 μg', 'description': 'AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.814', 'spread': '0.450', 'groupId': 'OG001'}, {'value': '1.01', 'spread': '0.784', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-treatment (Baseline measurement)', 'description': 'Forced Expiratory Volume in 1 second (FEV1), Late Asthmatic Response (LAR), is derived as the ratio of FEV1 Area Under Curve 4-10 hour post allergen challenge (AUC 4-10h) (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.'}, {'type': 'PRIMARY', 'title': 'FEV1, Late Asthmatic Response (LAR) - 1 Week After Last Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD8848, 30 μg', 'description': 'AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.'}, {'id': 'OG001', 'title': 'AZD8848, 60 μg', 'description': 'AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.616', 'spread': '0.296', 'groupId': 'OG001'}, {'value': '0.970', 'spread': '0.641', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 week after last dose', 'description': 'FEV1, Late Asthmatic Response (LAR), is derived as the ratio of FEV1 AUC 4-10h (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.'}, {'type': 'PRIMARY', 'title': 'FEV1, Late Asthmatic Response (LAR) - 4 Weeks After Last Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD8848, 30 μg', 'description': 'AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.'}, {'id': 'OG001', 'title': 'AZD8848, 60 μg', 'description': 'AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.759', 'spread': '0.397', 'groupId': 'OG001'}, {'value': '0.722', 'spread': '0.584', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks after last dose', 'description': 'FEV1, Late Asthmatic Response (LAR), is derived as the ratio of FEV1 AUC 4-10h (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.'}, {'type': 'SECONDARY', 'title': 'FEV1, Early Asthmatic Response (EAR) - Pre-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD8848, 30 μg', 'description': 'AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.'}, {'id': 'OG001', 'title': 'AZD8848, 60 μg', 'description': 'AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.524', 'spread': '0.241', 'groupId': 'OG001'}, {'value': '0.611', 'spread': '0.362', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-treatment (Baseline measurement)', 'description': 'FEV1, Early Asthmatic Response (EAR), is derived as the ratio of FEV1 Area Under Curve 0-2 hour post allergen challenge (AUC 0-2h) (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. 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Main part.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.037', 'groupId': 'OG001', 'lowerLimit': '0.001', 'upperLimit': '0.17'}, {'value': '0.082', 'groupId': 'OG002', 'lowerLimit': '0.018', 'upperLimit': '0.24'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '4 weeks after last dose, post allergen challenge', 'unitOfMeasure': '10^6 cells/g', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AZD8848, 30 μg', 'description': 'AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.'}, {'id': 'FG001', 'title': 'AZD8848, 60 μg', 'description': 'AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.'}], 'periods': [{'title': 'Pilot Part', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'comment': 'AZD8848 nasal spray 60 μg group was not participated in the Pilot part', 'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Main Part', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'AZD8848 nasal spray 30 μg group was not participated in the Main part', 'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'AZD8848, 30 μg', 'description': 'AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.'}, {'id': 'BG001', 'title': 'AZD8848, 60 μg', 'description': 'AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.3', 'groupId': 'BG000', 'lowerLimit': '23', 'upperLimit': '47'}, {'value': '33.0', 'groupId': 'BG001', 'lowerLimit': '19', 'upperLimit': '51'}, {'value': '32.3', 'groupId': 'BG002', 'lowerLimit': '21', 'upperLimit': '50'}, {'value': '33.9', 'groupId': 'BG003', 'lowerLimit': '19', 'upperLimit': '51'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'AZD8848 30 μg nasal spray was only done in Pilot part. 3 of the 28 placebo subjects were from the PILOT part and 25 placebo subjects were from the MAIN part.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-28', 'studyFirstSubmitDate': '2009-10-20', 'resultsFirstSubmitDate': '2015-08-31', 'studyFirstSubmitQcDate': '2009-10-20', 'lastUpdatePostDateStruct': {'date': '2016-02-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-12-17', 'studyFirstPostDateStruct': {'date': '2009-10-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FEV1, Late Asthmatic Response (LAR) - Pre-treatment', 'timeFrame': 'Pre-treatment (Baseline measurement)', 'description': 'Forced Expiratory Volume in 1 second (FEV1), Late Asthmatic Response (LAR), is derived as the ratio of FEV1 Area Under Curve 4-10 hour post allergen challenge (AUC 4-10h) (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.'}, {'measure': 'FEV1, Late Asthmatic Response (LAR) - 1 Week After Last Dose', 'timeFrame': '1 week after last dose', 'description': 'FEV1, Late Asthmatic Response (LAR), is derived as the ratio of FEV1 AUC 4-10h (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.'}, {'measure': 'FEV1, Late Asthmatic Response (LAR) - 4 Weeks After Last Dose', 'timeFrame': '4 weeks after last dose', 'description': 'FEV1, Late Asthmatic Response (LAR), is derived as the ratio of FEV1 AUC 4-10h (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.'}], 'secondaryOutcomes': [{'measure': 'FEV1, Early Asthmatic Response (EAR) - Pre-treatment', 'timeFrame': 'Pre-treatment (Baseline measurement)', 'description': 'FEV1, Early Asthmatic Response (EAR), is derived as the ratio of FEV1 Area Under Curve 0-2 hour post allergen challenge (AUC 0-2h) (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.'}, {'measure': 'FEV1, Early Asthmatic Response (EAR) - 1 Week After Last Dose', 'timeFrame': '1 week after last dose', 'description': 'FEV1, Early Asthmatic Response (EAR), is derived as the ratio of FEV1 AUC 0-2h (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.'}, {'measure': 'FEV1, Early Asthmatic Response (EAR) - 4 Weeks After Last Dose', 'timeFrame': '4 weeks after last dose', 'description': 'FEV1, Early Asthmatic Response (EAR), is derived as the ratio of FEV1 AUC 0-2h (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.'}, {'measure': 'PC20 Methacholine Challenge - Pre-treatment, Pre Allergen Challenge', 'timeFrame': 'Pre-treatment, pre allergen challenge', 'description': 'PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1'}, {'measure': 'PC20 Methacholine Challenge - Pre-treatment, Post Allergen Challenge', 'timeFrame': 'Pre-treatment, post allergen challenge', 'description': 'PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1'}, {'measure': 'PC20 Methacholine Challenge - 1 Week After Last Dose, Pre Allergen Challenge', 'timeFrame': '1 week after last dose, pre allergen challenge', 'description': 'PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1'}, {'measure': 'PC20 Methacholine Challenge - 1 Week After Last Dose, Post Allergen Challenge', 'timeFrame': '1 week after last dose, post allergen challenge', 'description': 'PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1'}, {'measure': 'PC20 Methacholine Challenge - 4 Weeks After Last Dose, Pre Allergen Challenge', 'timeFrame': '4 weeks after last dose, pre allergen challenge', 'description': 'PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1'}, {'measure': 'PC20 Methacholine Challenge - 4 Weeks After Last Dose, Post Allergen Challenge', 'timeFrame': '4 weeks after last dose, post allergen challenge', 'description': 'PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1'}, {'measure': 'Sputum Cellularity and Cytokines, Tumour Necrosis Factor Alpha (TNFα) - Pre-treatment, Pre Allergen Challenge', 'timeFrame': 'Pre-treatment, pre allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, TNFα - Pre-treatment, Post Allergen Challenge', 'timeFrame': 'Pre-treatment, post allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, TNFα - 1 Week After Last Dose, Pre Allergen Challenge', 'timeFrame': '1 week after last dose, pre allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, TNFα - 1 Week After Last Dose, Post Allergen Challenge', 'timeFrame': '1 week after last dose, post allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, TNFα - 4 Weeks After Last Dose, Pre Allergen Challenge', 'timeFrame': '4 weeks after last dose, pre allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, TNFα - 4 Weeks After Last Dose, Post Allergen Challenge', 'timeFrame': '4 weeks after last dose, post allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, Interleukin-1β (IL-1β) - Pre-treatment, Pre Allergen Challenge', 'timeFrame': 'Pre-treatment, pre allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, IL-1β - Pre-treatment, Post Allergen Challenge', 'timeFrame': 'Pre-treatment, post allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, IL-1β - 1 Week After Last Dose, Pre Allergen Challenge', 'timeFrame': '1 week after last dose, pre allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, IL-1β - 1 Week After Last Dose, Post Allergen Challenge', 'timeFrame': '1 week after last dose, post allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, IL-1β - 4 Weeks After Last Dose, Pre Allergen Challenge', 'timeFrame': '4 weeks after last dose, pre allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, IL-1β - 4 Weeks After Last Dose, Post Allergen Challenge', 'timeFrame': '4 weeks after last dose, post allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, Interleukin-5 (IL-5) - Pre-treatment, Pre Allergen Challenge', 'timeFrame': 'Pre-treatment, pre allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, IL-5 - Pre-treatment, Post Allergen Challenge', 'timeFrame': 'Pre-treatment, post allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, IL-5 - 1 Week After Last Dose, Pre Allergen Challenge', 'timeFrame': '1 week after last dose, pre allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, IL-5 - 1 Week After Last Dose, Post Allergen Challenge', 'timeFrame': '1 week after last dose, post allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, IL-5 - 4 Weeks After Last Dose, Pre Allergen Challenge', 'timeFrame': '4 weeks after last dose, pre allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, IL-5 - 4 Weeks After Last Dose, Post Allergen Challenge', 'timeFrame': '4 weeks after last dose, post allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, Interleukin-6 (IL-6) - Pre-treatment, Pre Allergen Challenge', 'timeFrame': 'Pre-treatment, pre allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, IL-6 - Pre-treatment, Post Allergen Challenge', 'timeFrame': 'Pre-treatment, post allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, IL-6 - 1 Week After Last Dose, Pre Allergen Challenge', 'timeFrame': '1 week after last dose, pre allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, IL-6 - 1 Week After Last Dose, Post Allergen Challenge', 'timeFrame': '1 week after last dose, post allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, IL-6 - 4 Weeks After Last Dose, Pre Allergen Challenge', 'timeFrame': '4 weeks after last dose, pre allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, IL-6 - 4 Weeks After Last Dose, Post Allergen Challenge', 'timeFrame': '4 weeks after last dose, post allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, Interleukin-8 (IL-8) - Pre-treatment, Pre Allergen Challenge', 'timeFrame': 'Pre-treatment, pre allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, IL-8 - Pre-treatment, Post Allergen Challenge', 'timeFrame': 'Pre-treatment, post allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, IL-8 - 1 Week After Last Dose, Pre Allergen Challenge', 'timeFrame': '1 week after last dose, pre allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, IL-8 - 1 Week After Last Dose, Post Allergen Challenge', 'timeFrame': '1 week after last dose, post allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, IL-8 - 4 Weeks After Last Dose, Pre Allergen Challenge', 'timeFrame': '4 weeks after last dose, pre allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, IL-8 - 4 Weeks After Last Dose, Post Allergen Challenge', 'timeFrame': '4 weeks after last dose, post allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, Interleukin-10 (IL-10) - Pre-treatment, Pre Allergen Challenge', 'timeFrame': 'Pre-treatment, pre allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, IL-10 - Pre-treatment, Post Allergen Challenge', 'timeFrame': 'Pre-treatment, post allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, IL-10 - 1 Week After Last Dose, Pre Allergen Challenge', 'timeFrame': '1 week after last dose, pre allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, IL-10 - 1 Week After Last Dose, Post Allergen Challenge', 'timeFrame': '1 week after last dose, post allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, IL-10 - 4 Weeks After Last Dose, Pre Allergen Challenge', 'timeFrame': '4 weeks after last dose, pre allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, IL-10 - 4 Weeks After Last Dose, Post Allergen Challenge', 'timeFrame': '4 weeks after last dose, post allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, Interleukin-13 (IL-13) - Pre-treatment, Pre Allergen Challenge', 'timeFrame': 'Pre-treatment, pre allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, IL-13 - Pre-treatment, Post Allergen Challenge', 'timeFrame': 'Pre-treatment, post allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, IL-13 - 1 Week After Last Dose, Pre Allergen Challenge', 'timeFrame': '1 week after last dose, pre allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, IL-13 - 1 Week After Last Dose, Post Allergen Challenge', 'timeFrame': '1 week after last dose, post allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, IL-13 - 4 Weeks After Last Dose, Pre Allergen Challenge', 'timeFrame': '4 weeks after last dose, pre allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, IL-13 - 4 Weeks After Last Dose, Post Allergen Challenge', 'timeFrame': '4 weeks after last dose, post allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, Total Cells/g - Pre-treatment, Pre Allergen Challenge', 'timeFrame': 'Pre-treatment, pre allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, Total Cells/g - Pre-treatment, Post Allergen Challenge', 'timeFrame': 'Pre-treatment, post allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, Total Cells/g - 1 Week After Last Dose, Pre Allergen Challenge', 'timeFrame': '1 week after last dose, pre allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, Total Cells/g - 1 Week After Last Dose, Post Allergen Challenge', 'timeFrame': '1 week after last dose, post allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, Total Cells/g - 4 Weeks After Last Dose, Pre Allergen Challenge', 'timeFrame': '4 weeks after last dose, pre allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, Total Cells/g - 4 Weeks After Last Dose, Post Allergen Challenge', 'timeFrame': '4 weeks after last dose, post allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, Eosinophils - Pre-treatment, Pre Allergen Challenge', 'timeFrame': 'Pre-treatment, pre allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, Eosinophils - Pre-treatment, Post Allergen Challenge', 'timeFrame': 'Pre-treatment, post allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, Eosinophils - 1 Week After Last Dose, Pre Allergen Challenge', 'timeFrame': '1 week after last dose, pre allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, Eosinophils - 1 Week After Last Dose, Post Allergen Challenge', 'timeFrame': '1 week after last dose, post allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, Eosinophils - 4 Weeks After Last Dose, Pre Allergen Challenge', 'timeFrame': '4 weeks after last dose, pre allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, Eosinophils - 4 Weeks After Last Dose, Post Allergen Challenge', 'timeFrame': '4 weeks after last dose, post allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, Neutrophils - Pre-treatment, Pre Allergen Challenge', 'timeFrame': 'Pre-treatment, pre allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, Neutrophils - Pre-treatment, Post Allergen Challenge', 'timeFrame': 'Pre-treatment, post allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, Neutrophils - 1 Week After Last Dose, Pre Allergen Challenge', 'timeFrame': '1 week after last dose, pre allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, Neutrophils - 1 Week After Last Dose, Post Allergen Challenge', 'timeFrame': '1 week after last dose, post allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, Neutrophils - 4 Weeks After Last Dose, Pre Allergen Challenge', 'timeFrame': '4 weeks after last dose, pre allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, Neutrophils - 4 Weeks After Last Dose, Post Allergen Challenge', 'timeFrame': '4 weeks after last dose, post allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, Macrophages - Pre-treatment, Pre Allergen Challenge', 'timeFrame': 'Pre-treatment, pre allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, Macrophages - Pre-treatment, Post Allergen Challenge', 'timeFrame': 'Pre-treatment, post allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, Macrophages - 1 Week After Last Dose, Pre Allergen Challenge', 'timeFrame': '1 week after last dose, pre allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, Macrophages - 1 Week After Last Dose, Post Allergen Challenge', 'timeFrame': '1 week after last dose, post allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, Macrophages - 4 Weeks After Last Dose, Pre Allergen Challenge', 'timeFrame': '4 weeks after last dose, pre allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, Macrophages - 4 Weeks After Last Dose, Post Allergen Challenge', 'timeFrame': '4 weeks after last dose, post allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, Lymphocytes - Pre-treatment, Pre Allergen Challenge', 'timeFrame': 'Pre-treatment, pre allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, Lymphocytes - Pre-treatment, Post Allergen Challenge', 'timeFrame': 'Pre-treatment, post allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, Lymphocytes - 1 Week After Last Dose, Pre Allergen Challenge', 'timeFrame': '1 week after last dose, pre allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, Lymphocytes - 1 Week After Last Dose, Post Allergen Challenge', 'timeFrame': '1 week after last dose, post allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, Lymphocytes - 4 Weeks After Last Dose, Pre Allergen Challenge', 'timeFrame': '4 weeks after last dose, pre allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, Lymphocytes - 4 Weeks After Last Dose, Post Allergen Challenge', 'timeFrame': '4 weeks after last dose, post allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, Epithelial Cells - Pre-treatment, Pre Allergen Challenge', 'timeFrame': 'Pre-treatment, pre allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, Epithelial Cells - Pre-treatment, Post Allergen Challenge', 'timeFrame': 'Pre-treatment, post allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, Epithelial Cells - 1 Week After Last Dose, Pre Allergen Challenge', 'timeFrame': '1 week after last dose, pre allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, Epithelial Cells - 1 Week After Last Dose, Post Allergen Challenge', 'timeFrame': '1 week after last dose, post allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, Epithelial Cells - 4 Weeks After Last Dose, Pre Allergen Challenge', 'timeFrame': '4 weeks after last dose, pre allergen challenge'}, {'measure': 'Sputum Cellularity and Cytokines, Epithelial Cells - 4 Weeks After Last Dose, Post Allergen Challenge', 'timeFrame': '4 weeks after last dose, post allergen challenge'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Allergic Asthma']}, 'referencesModule': {'references': [{'pmid': '31856838', 'type': 'DERIVED', 'citation': "Leaker BR, Singh D, Lindgren S, Almqvist G, Eriksson L, Young B, O'Connor B. Effects of the Toll-like receptor 7 (TLR7) agonist, AZD8848, on allergen-induced responses in patients with mild asthma: a double-blind, randomised, parallel-group study. Respir Res. 2019 Dec 19;20(1):288. doi: 10.1186/s12931-019-1252-2."}], 'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=191&filename=D0540C00004_Study_Synopsis.pdf', 'label': 'CSR Synopsis'}]}, 'descriptionModule': {'briefSummary': 'AZD8848 is a new drug that is being tested for the treatment of asthma and allergic rhinitis (hayfever). This study will be in two parts and will include 59 asthmatic patients in total. The first part will investigate the tolerability and safety of AZD8848 while the second part will investigate both the therapeutic effect of AZD8848 and how well patients tolerate the drug.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* FEV1 \\> 70 % of predicted normal pre-bronchodilator\n* Documented history of asthma\n* Presence of allergic sensitivity\n\nExclusion Criteria:\n\n* Clinically relevant disease and/or abnormality (past or present), which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the results of the study, or the patient's ability to participate in the study.\n* Symptomatic allergic rhinitis\n* Any clinical relevant abnormal findings in physical examination or assessment which may put the patient at risk because of participation in the study"}, 'identificationModule': {'nctId': 'NCT00999466', 'briefTitle': 'The Tolerability and Effects of AZD8848 in Allergic Asthma Subjects Challenged With Inhaled Allergen', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Double-blind, Placebo-controlled, Randomised, Parallel Group, Phase IIa Study to Investigate the Efficacy, Tolerability and Safety of 8 Doses of AZD8848 Administered Intranasally Once Weekly in Mild to Moderate Allergic Asthma Subjects Challenged With an Inhaled Allergen.', 'orgStudyIdInfo': {'id': 'D0540C00004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'AZD8848 (30 μg PILOT part and 60 μg MAIN part)', 'interventionNames': ['Drug: AZD8848']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AZD8848', 'type': 'DRUG', 'description': 'Nasal spray, solution 0.6mg/ mL. Once weekly for 7 weeks, 8 doses in total.', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Nasal spray, solution. Once weekly for 7 weeks, 8 doses in total.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Leif Eriksson, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca R&D Lund'}, {'name': 'Brian Leaker, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Respiratory Clinical Trials'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}