Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-25 @ 7:18 PM
Study NCT ID:
NCT00783432
Status:
COMPLETED
Last Update Posted:
2009-10-06
First Post:
2008-10-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Safety and Tolerability of a Nasal Spray in Patients With Chronic Allergic or Nonallergic Rhinitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C020976', 'term': 'azelastine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wwheeler@medapharma.us', 'phone': '732-564-2351', 'title': 'William Wheeler, PhD', 'organization': 'Meda Pharmaceuticals'}, 'certainAgreement': {'otherDetails': 'For multicenter studies, joint publication is required to assure that the initial publication is based on all data from all sites and investigators participating in these studies agree not to present data gathered individually or by subgroup centers before the initial publication unless jointly agreed by all other investigators and the Sponsor. Authorship will be determined by mutual agreement.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Astepro Nasal Spray', 'description': '(0.1% azelastine hydrochloride)', 'otherNumAffected': 163, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Astelin Nasal Spray', 'description': '(0.1% azelastine hydrochloride)', 'otherNumAffected': 146, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 428, 'numEvents': 49, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 430, 'numEvents': 43, 'numAffected': 43}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 428, 'numEvents': 34, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 430, 'numEvents': 25, 'numAffected': 25}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 428, 'numEvents': 29, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 430, 'numEvents': 32, 'numAffected': 32}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 428, 'numEvents': 28, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 430, 'numEvents': 32, 'numAffected': 32}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pharyngolaryngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 428, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 430, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Battery change for internal cardiac defibrillator', 'stats': [{'groupId': 'EG000', 'numAtRisk': 428, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 430, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sialoadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 428, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 430, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 428, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 430, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 428, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 430, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Knee traumatism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 428, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 430, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rectal Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 428, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 430, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Exacerbation angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 428, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 430, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Central Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 428, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 430, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Exacerbation right shoulder pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 428, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 430, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Basal Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 428, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 430, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Removal of bladder stones', 'stats': [{'groupId': 'EG000', 'numAtRisk': 428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 430, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ovarian Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 430, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Exertional dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 430, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 430, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia Chlamidalis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 430, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Spontaneous Abortion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 430, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fracture left foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 430, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Broken nose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 430, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 430, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper Abdominal Colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 430, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Total right hip replacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 428, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 430, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Reporting Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '430', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Astepro Nasal Spray', 'description': '(0.1% azelastine hydrochloride)'}, {'id': 'OG001', 'title': 'Astelin Nasal Spray', 'description': '(0.1% azelastine hydrochloride)'}], 'classes': [{'categories': [{'measurements': [{'value': '207', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'An AE can be any unfavorable and unintended sign,symptom, or disease temporally associated with the use of this investigational product, whether or not considered related to the investigational product. An AE is any untoward medical occurrence in a subject which does not necessarily have a causal relationship with this treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants for analysis was based on a safety population that included any subject who received at least one dose of study medication.', 'anticipatedPostingDate': '2008-11'}, {'type': 'PRIMARY', 'title': 'Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '430', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Astepro Nasal Spray', 'description': '(0.1% azelastine hydrochloride)'}, {'id': 'OG001', 'title': 'Astelin Nasal Spray', 'description': '(0.1% azelastine hydrochloride)'}], 'classes': [{'title': 'Conjunctiva: Total baseline', 'categories': [{'measurements': [{'value': '428', 'groupId': 'OG000'}, {'value': '430', 'groupId': 'OG001'}]}]}, {'title': 'Conjunctiva: baseline-None', 'categories': [{'measurements': [{'value': '264', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}]}]}, {'title': 'Conjunctiva: baseline-Mild (1+)', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}]}, {'title': 'Conjunctiva: baseline-Moderate (2+)', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'Conjunctiva: baseline-Severe (3+)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Conjunctiva: Total M12/ET', 'categories': [{'measurements': [{'value': '414', 'groupId': 'OG000'}, {'value': '417', 'groupId': 'OG001'}]}]}, {'title': 'Conjunctiva: M12/ET-None', 'categories': [{'measurements': [{'value': '366', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}]}]}, {'title': 'Conjunctiva: M12/ET-Mild (1+)', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'Conjunctiva: M12/ET-Moderate (2+)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Conjunctiva:M12/ET-Severe (3+)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Tympanic membranes: Total baseline', 'categories': [{'measurements': [{'value': '428', 'groupId': 'OG000'}, {'value': '430', 'groupId': 'OG001'}]}]}, {'title': 'Tympanic membranes: baseline-None', 'categories': [{'measurements': [{'value': '342', 'groupId': 'OG000'}, {'value': '344', 'groupId': 'OG001'}]}]}, {'title': 'Tympanic membranes: baseline-Mild (1+)', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}, {'title': 'Tympanic membranes:baselineModerate (2+)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Tympanic membranes: baseline-Severe (3+)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Tympanic membranes: Total M12/ET', 'categories': [{'measurements': [{'value': '414', 'groupId': 'OG000'}, {'value': '417', 'groupId': 'OG001'}]}]}, {'title': 'Tympanic membranes: M12/ET-None', 'categories': [{'measurements': [{'value': '405', 'groupId': 'OG000'}, {'value': '408', 'groupId': 'OG001'}]}]}, {'title': 'Tympanic membranes:M12/ET-Mild (1+)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Tympanic membranes: M12/ET-Moderate (2+)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Tympanic membranes:M12/ET Severe (3+)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lymphadenopathy: Total baseline', 'categories': [{'measurements': [{'value': '428', 'groupId': 'OG000'}, {'value': '430', 'groupId': 'OG001'}]}]}, {'title': 'Lymphadenopathy: baseline-None', 'categories': [{'measurements': [{'value': '389', 'groupId': 'OG000'}, {'value': '393', 'groupId': 'OG001'}]}]}, {'title': 'Lymphadenopathy: baseline-Mild (1+)', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'Lymphadenopathy: baseline-Moderate (2+)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Lymphadenopathy: baseline-Severe (3+)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Lymphadenopathy: Total M12/ET', 'categories': [{'measurements': [{'value': '414', 'groupId': 'OG000'}, {'value': '417', 'groupId': 'OG001'}]}]}, {'title': 'Lymphadenopathy: M12/ET-None', 'categories': [{'measurements': [{'value': '408', 'groupId': 'OG000'}, {'value': '407', 'groupId': 'OG001'}]}]}, {'title': 'Lymphadenopathy:M12/ET-Mild (1+)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Lymphadenopathy:M12/ET-Moderate (2+)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lymphadenopathy: M12/ET-Severe (3+)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Mucosal edema: Total baseline', 'categories': [{'measurements': [{'value': '428', 'groupId': 'OG000'}, {'value': '430', 'groupId': 'OG001'}]}]}, {'title': 'Mucosal edema: baseline-None', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Mucosal edema: baseline-Mild (1+)', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}, {'title': 'Mucosal edema: baseline-Moderate (2+)', 'categories': [{'measurements': [{'value': '191', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}]}, {'title': 'Mucosal edema: baseline-Severe (3+)', 'categories': [{'measurements': [{'value': '114', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}]}, {'title': 'Mucosal edema: Total M12/ET', 'categories': [{'measurements': [{'value': '414', 'groupId': 'OG000'}, {'value': '417', 'groupId': 'OG001'}]}]}, {'title': 'Mucosal edema:M12/ET-None', 'categories': [{'measurements': [{'value': '160', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}]}, {'title': 'Mucosal edema: M12/ET-Mild (1+)', 'categories': [{'measurements': [{'value': '176', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}]}]}, {'title': 'Mucosal edema: M12/ET-Moderate (2+)', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}]}, {'title': 'Mucosal edema: M12/ET-Severe (3+)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Nasal discharge: Total baseline', 'categories': [{'measurements': [{'value': '428', 'groupId': 'OG000'}, {'value': '430', 'groupId': 'OG001'}]}]}, {'title': 'Nasal discharge: baseline-None', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'Nasal discharge: baseline-Mild (1+)', 'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}]}, {'title': 'Nasal discharge: baseline-Moderate (2+)', 'categories': [{'measurements': [{'value': '179', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}]}, {'title': 'Nasal discharge: baseline-Severe (3+)', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}]}, {'title': 'Nasal discharge: Total M12/ET', 'categories': [{'measurements': [{'value': '414', 'groupId': 'OG000'}, {'value': '417', 'groupId': 'OG001'}]}]}, {'title': 'Nasal discharge:M12/ET-None', 'categories': [{'measurements': [{'value': '178', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}]}, {'title': 'Nasal discharge: M12/ET-Mild (1+)', 'categories': [{'measurements': [{'value': '188', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}]}, {'title': 'Nasal discharge: M12/ET-Moderate (2+)', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'Nasal discharge:M12/ET-Severe (3+)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Mucosal erythema: Total baseline', 'categories': [{'measurements': [{'value': '428', 'groupId': 'OG000'}, {'value': '430', 'groupId': 'OG001'}]}]}, {'title': 'Mucosal erythema: baseline-None', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}]}, {'title': 'Mucosal erythema: baseline-Mild (1+)', 'categories': [{'measurements': [{'value': '120', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}]}, {'title': 'Mucosal erythema: baseline-Monderate (2+)', 'categories': [{'measurements': [{'value': '171', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}]}, {'title': 'Mucosal erythema: baseline-Severe (3+)', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}, {'title': 'Mucosal erythema: Total M12/ET', 'categories': [{'measurements': [{'value': '414', 'groupId': 'OG000'}, {'value': '417', 'groupId': 'OG001'}]}]}, {'title': 'Mucosal erythema: M12/ET-None', 'categories': [{'measurements': [{'value': '213', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}]}, {'title': 'Mucosal erythema: M12/ET-Mild (1+)', 'categories': [{'measurements': [{'value': '152', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}]}, {'title': 'Mucosal erythema: M12/ET-Moderate (2+)', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Mucosal erythema:M12/ET-Severe (3+)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Mucosal bleeding: Total baseline', 'categories': [{'measurements': [{'value': '428', 'groupId': 'OG000'}, {'value': '430', 'groupId': 'OG001'}]}]}, {'title': 'Mucosal bleeding: baseline-None', 'categories': [{'measurements': [{'value': '362', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}]}, {'title': 'Mucosal bleeding: baseline-Mild (1+)', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Mucosal bleeding: baseline-Moderate (2+)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Mucosal bleeding: baseline-Severe (3+)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Mucosal bleeding: Total M12/ET', 'categories': [{'measurements': [{'value': '414', 'groupId': 'OG000'}, {'value': '417', 'groupId': 'OG001'}]}]}, {'title': 'Mucosal bleeding: M12/ET-None', 'categories': [{'measurements': [{'value': '402', 'groupId': 'OG000'}, {'value': '403', 'groupId': 'OG001'}]}]}, {'title': 'Mucosal bleeding: M12/ET-Mild (1+)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Mucosal bleeding: M12/ET-Moderate (2+)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Mucosal bleeding: M12/ET-Severe (3+)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Mucosal ulcerations: Total baseline', 'categories': [{'measurements': [{'value': '428', 'groupId': 'OG000'}, {'value': '430', 'groupId': 'OG001'}]}]}, {'title': 'Mucosal ulcerations: baseline-None', 'categories': [{'measurements': [{'value': '348', 'groupId': 'OG000'}, {'value': '362', 'groupId': 'OG001'}]}]}, {'title': 'Mucosal ulcerations: baseline-Mild (1+)', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'Mucosal ulcerations: baseline-Moderate (2+)', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Mucosal ulcerations: baseline-Severe (3+)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Mucosal ulcerations: Total M12/ET', 'categories': [{'measurements': [{'value': '414', 'groupId': 'OG000'}, {'value': '417', 'groupId': 'OG001'}]}]}, {'title': 'Mucosal ulcerations: M12/ET-None', 'categories': [{'measurements': [{'value': '401', 'groupId': 'OG000'}, {'value': '404', 'groupId': 'OG001'}]}]}, {'title': 'Mucosal ulcerations: M12/ET-Mild (1+)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Mucosal ulcerations: M12/ET-Moderate (2+)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Mucosal ulcerations: M12/ET-Severe (3+)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Crusting of mucosa: Total baseline', 'categories': [{'measurements': [{'value': '428', 'groupId': 'OG000'}, {'value': '430', 'groupId': 'OG001'}]}]}, {'title': 'Crusting of mucosa: baseline-None', 'categories': [{'measurements': [{'value': '293', 'groupId': 'OG000'}, {'value': '311', 'groupId': 'OG001'}]}]}, {'title': 'Crusting of mucosa: baseline-Mild (1+)', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}]}, {'title': 'Crusting of mucosa: baseline-Moderate (2+)', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Crusting of mucosa: baseline-Severe (3+)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Crusting of mucosa: Total M12/ET', 'categories': [{'measurements': [{'value': '414', 'groupId': 'OG000'}, {'value': '417', 'groupId': 'OG001'}]}]}, {'title': 'Crusting of mucosa: M12/ET-None', 'categories': [{'measurements': [{'value': '387', 'groupId': 'OG000'}, {'value': '382', 'groupId': 'OG001'}]}]}, {'title': 'Crusting of mucosa: M12/ET-Mild (1+)', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'Crusting of mucosa: M12/ET-Moderate (2+)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Crusting of mucosa:M12/ET-Severe (3+)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Epistaxis: Total baseline', 'categories': [{'measurements': [{'value': '428', 'groupId': 'OG000'}, {'value': '430', 'groupId': 'OG001'}]}]}, {'title': 'Epistaxis: baseline None', 'categories': [{'measurements': [{'value': '402', 'groupId': 'OG000'}, {'value': '416', 'groupId': 'OG001'}]}]}, {'title': 'Epistaxis: baseline Grade 2', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Epistaxis: baseline Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Epistaxis: baseline Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Epistaxis:Total M12/ET', 'categories': [{'measurements': [{'value': '414', 'groupId': 'OG000'}, {'value': '417', 'groupId': 'OG001'}]}]}, {'title': 'Epistaxis: M12/ET None', 'categories': [{'measurements': [{'value': '413', 'groupId': 'OG000'}, {'value': '415', 'groupId': 'OG001'}]}]}, {'title': 'Epistaxis: M12/ETGrade 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Epistaxis:M12/ET Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Epistaxis: M12/ETGrade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Ulceration: Total baseline', 'categories': [{'measurements': [{'value': '428', 'groupId': 'OG000'}, {'value': '430', 'groupId': 'OG001'}]}]}, {'title': 'Ulceration: baseline None', 'categories': [{'measurements': [{'value': '365', 'groupId': 'OG000'}, {'value': '373', 'groupId': 'OG001'}]}]}, {'title': 'Ulceration: baseline Grade 2', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}, {'title': 'Ulceration: baseline Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Ulceration: baseline Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Ulceration: Total M12/ET', 'categories': [{'measurements': [{'value': '413', 'groupId': 'OG000'}, {'value': '417', 'groupId': 'OG001'}]}]}, {'title': 'Ulceration:M12/ET None', 'categories': [{'measurements': [{'value': '404', 'groupId': 'OG000'}, {'value': '411', 'groupId': 'OG001'}]}]}, {'title': 'Ulceration: M12/ET Grade 2', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Ulceration: M12/ET Grade 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Ulceration: M12/ET Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pain: Total baseline', 'categories': [{'measurements': [{'value': '428', 'groupId': 'OG000'}, {'value': '430', 'groupId': 'OG001'}]}]}, {'title': 'Pain: baseline None', 'categories': [{'measurements': [{'value': '377', 'groupId': 'OG000'}, {'value': '382', 'groupId': 'OG001'}]}]}, {'title': 'Pain: baseline Grade 2', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Pain: baseline Grade 3', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Pain: baseline Grade 4', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Pain: Total M12/ET', 'categories': [{'measurements': [{'value': '413', 'groupId': 'OG000'}, {'value': '417', 'groupId': 'OG001'}]}]}, {'title': 'Pain: M12/ET None', 'categories': [{'measurements': [{'value': '401', 'groupId': 'OG000'}, {'value': '409', 'groupId': 'OG001'}]}]}, {'title': 'Pain: M12/ET Grade 2', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Pain: M12/ET Grade 3', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Pain: M12/ET Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline and 12 months/ET', 'description': 'Examination of head and neck(scale: 0, 1+=Mild, 2+=Moderate, 3++Severe) for mucosal edema, nasal discharge, mucosal erythema, mucosal bleeding, mucosal ulcerations, crusting of mucosa, conjunctiva, tympanic membranes, lymph nodes of head and neck. Direct visual nasal examination (scale: None, Grade 2, Grade 3, and Grade 4) for epistaxis,ulceration and pain.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2008-11'}, {'type': 'SECONDARY', 'title': 'Adult Mini-Rhinoconjuctivitis Quality of Life Questionnaire. Change From Baseline in RQLQ Score at Months 1,3,6,9 and 12/or Early Termination.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '430', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Astepro Nasal Spray', 'description': '(0.1% azelastine hydrochloride)'}, {'id': 'OG001', 'title': 'Astelin Nasal Spray', 'description': '(0.1% azelastine hydrochloride)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.25', 'spread': '1.103', 'groupId': 'OG000'}, {'value': '2.18', 'spread': '1.050', 'groupId': 'OG001'}]}]}, {'title': 'Month 1', 'categories': [{'measurements': [{'value': '-0.77', 'spread': '1.007', 'groupId': 'OG000'}, {'value': '-0.83', 'spread': '0.959', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '-1.00', 'spread': '1.063', 'groupId': 'OG000'}, {'value': '-1.00', 'spread': '1.048', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '-1.04', 'spread': '1.206', 'groupId': 'OG000'}, {'value': '-0.94', 'spread': '1.230', 'groupId': 'OG001'}]}]}, {'title': 'Month 9', 'categories': [{'measurements': [{'value': '-1.09', 'spread': '1.228', 'groupId': 'OG000'}, {'value': '-1.16', 'spread': '1.197', 'groupId': 'OG001'}]}]}, {'title': 'Month 12/Early termination', 'categories': [{'measurements': [{'value': '-0.88', 'spread': '1.385', 'groupId': 'OG000'}, {'value': '-0.90', 'spread': '1.339', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.368', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'This is the Baseline P-Value', 'groupDescription': 'Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.327', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'This P-Value if for Month 1', 'groupDescription': 'Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.991', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'This P-Value is for Month 3', 'groupDescription': 'Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.168', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'This P-Value is for Month 6', 'groupDescription': 'Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.319', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'This P-Value is for Month 9', 'groupDescription': 'Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.725', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'This P-Value is for Month 12/ET', 'groupDescription': 'Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, months 1,3,6,9 and 12/or early termination', 'description': 'The RQLQ consists of 7 domains rated on a 7-point scale with 0 being not troubled by the allergy symptoms,and 6 being extremely troubled. Total possible RQLQ score is 42 at any given evaluation. Scale of how troubled is:0=Not,2=Somewhat,3=Moderate,4=Quite a bit,5=Very,6 Extremely. Only change from baseline to month 12 primary analysis is provided.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is based on safety population, which is defined as subjects who took at least one dose of study medication.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Astepro Nasal Spray', 'description': '(0.1% azelastine hydrochloride)'}, {'id': 'FG001', 'title': 'Astelin Nasal Spray', 'description': '(0.1% azelastine hydrochloride)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'This includes 2 subjects that received a randomization number but did not receive study drug', 'groupId': 'FG000', 'numSubjects': '430'}, {'comment': 'This includes 2 subjects that received a randomization number but did not receive study drug', 'groupId': 'FG001', 'numSubjects': '432'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '345'}, {'groupId': 'FG001', 'numSubjects': '354'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '78'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'subject moved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}], 'recruitmentDetails': 'First observation 24 July 2006 and last observation 28 Dec 2007', 'preAssignmentDetails': 'Subjects participated in a one-week screening period to identify appropriate subjects based on symptom scores'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'BG000'}, {'value': '430', 'groupId': 'BG001'}, {'value': '858', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Astepro Nasal Spray', 'description': '(0.1% azelastine hydrochloride)'}, {'id': 'BG001', 'title': 'Astelin Nasal Spray', 'description': '(0.1% azelastine hydrochloride)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '389', 'groupId': 'BG000'}, {'value': '391', 'groupId': 'BG001'}, {'value': '780', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.2', 'spread': '14.95', 'groupId': 'BG000'}, {'value': '41.3', 'spread': '15.12', 'groupId': 'BG001'}, {'value': '41.2', 'spread': '15.03', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '221', 'groupId': 'BG000'}, {'value': '236', 'groupId': 'BG001'}, {'value': '457', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '207', 'groupId': 'BG000'}, {'value': '194', 'groupId': 'BG001'}, {'value': '401', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '410', 'groupId': 'BG000'}, {'value': '405', 'groupId': 'BG001'}, {'value': '815', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Australia', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}]}, {'title': 'Europe', 'categories': [{'measurements': [{'value': '388', 'groupId': 'BG000'}, {'value': '391', 'groupId': 'BG001'}, {'value': '779', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Duration of Rhinitis', 'classes': [{'categories': [{'measurements': [{'value': '10.5', 'spread': '11.04', 'groupId': 'BG000'}, {'value': '11.3', 'spread': '10.85', 'groupId': 'BG001'}, {'value': '10.9', 'spread': '10.95', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total Nasal Symptom Score (AM + PM)', 'classes': [{'categories': [{'measurements': [{'value': '9.69', 'spread': '4.506', 'groupId': 'BG000'}, {'value': '9.96', 'spread': '4.725', 'groupId': 'BG001'}, {'value': '9.82', 'spread': '4.617', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'TNSS scale: 0=no symptoms, 1=mild symptoms, 2=moderate symptoms and 3 = severe symptoms scored twice daily such that the maximum daily score is 24.', 'unitOfMeasure': 'units on a scale (0-3)', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 862}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-10-01', 'studyFirstSubmitDate': '2008-10-30', 'resultsFirstSubmitDate': '2008-12-29', 'studyFirstSubmitQcDate': '2008-10-30', 'lastUpdatePostDateStruct': {'date': '2009-10-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-08-27', 'studyFirstPostDateStruct': {'date': '2008-10-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Reporting Adverse Events', 'timeFrame': '12 months', 'description': 'An AE can be any unfavorable and unintended sign,symptom, or disease temporally associated with the use of this investigational product, whether or not considered related to the investigational product. An AE is any untoward medical occurrence in a subject which does not necessarily have a causal relationship with this treatment.'}, {'measure': 'Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.', 'timeFrame': 'baseline and 12 months/ET', 'description': 'Examination of head and neck(scale: 0, 1+=Mild, 2+=Moderate, 3++Severe) for mucosal edema, nasal discharge, mucosal erythema, mucosal bleeding, mucosal ulcerations, crusting of mucosa, conjunctiva, tympanic membranes, lymph nodes of head and neck. Direct visual nasal examination (scale: None, Grade 2, Grade 3, and Grade 4) for epistaxis,ulceration and pain.'}], 'secondaryOutcomes': [{'measure': 'Adult Mini-Rhinoconjuctivitis Quality of Life Questionnaire. Change From Baseline in RQLQ Score at Months 1,3,6,9 and 12/or Early Termination.', 'timeFrame': 'baseline, months 1,3,6,9 and 12/or early termination', 'description': 'The RQLQ consists of 7 domains rated on a 7-point scale with 0 being not troubled by the allergy symptoms,and 6 being extremely troubled. Total possible RQLQ score is 42 at any given evaluation. Scale of how troubled is:0=Not,2=Somewhat,3=Moderate,4=Quite a bit,5=Very,6 Extremely. Only change from baseline to month 12 primary analysis is provided.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Allergic Rhinitis', 'Nonallergic Rhinitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if Astepro Nasal Spray (0.1% azelastine hydrochloride) is as safe as Astelin Nasal Spray (0.1% azelastine hydrochloride)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male and female patients 12 years of age and older with an established history (\\> 1 year) of rhinitis due to perennial allergies, non-allergic triggers or vasomotor rhinitis (VMR).\n2. Provide written informed consent/pediatric assent. If the patient is a minor, a parent or legal guardian must give written informed consent\n3. Willing and able to comply with the study requirements, including daily use of medication for a one year period, even if symptoms are not bothersome.\n4. General good health and free of any disease or concomitant treatment that could interfere with the interpretation of the study results as determined by the investigator or the sponsor's medical officer\n5. Patients receiving immunotherapy (antigen desensitization) must be on a stable maintenance regimen for at least 30 days before the first study visit (adjustments to regimen following a brief period of missed injections does not preclude participation)\n\nExclusion Criteria:\n\n1. The use of any investigational drug within 30 days prior to screening. No other investigational products are permitted for use during the conduct of this study\n2. Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose (Splenda® brand sweetener)\n3. Women who are pregnant or nursing\n4. Women of childbearing potential who are not abstinent and not practicing a medically acceptable method of contraception. Female patients must practice an acceptable contraceptive technique for 30 days before randomization and agree to continue its use during treatment and for 30 days after the last dose of study drug. Oral, intrauterine, implantable, injectable contraceptives, or a double barrier form of contraception are acceptable and the medication including dose, device or method must have been stable for at least 30 days before the first dose of study drug.\n5. Nasal disease(s) likely to affect deposition of intranasal medication, such as sinusitis,rhinitis medicamentosa or clinically significant nasal polyposis or nasal structural abnormalities\n6. Patients with asthma (with the exception of mild, intermittent asthma) or other significant pulmonary disease such as Chronic Obstructive Pulmonary Disease\n7. Patients with a known history of alcohol or drug abuse\n8. Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor, might significantly alter the evaluation of study\n9. Clinically relevant abnormal history and/or physical findings which, in the opinion of the investigator or sponsor, would interfere with the objectives of the study or that may preclude compliance with the study procedures\n10. Study site staff, immediate relatives of study site staff, or other individuals who would have access to the clinical study protocol"}, 'identificationModule': {'nctId': 'NCT00783432', 'briefTitle': 'Study to Evaluate the Safety and Tolerability of a Nasal Spray in Patients With Chronic Allergic or Nonallergic Rhinitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Meda Pharmaceuticals'}, 'officialTitle': 'Active-Controlled Trial of the Safety and Tolerability of a MP03-33 in Patients With Chronic Allergic or Nonallergic Rhinitis', 'orgStudyIdInfo': {'id': 'MP432'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Astepro Nasal Spray (0.1% azelastine hydrochloride)', 'interventionNames': ['Drug: Astepro Nasal Spray (0.1% azelastine hydrochloride)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Astelin Nasal Spray (0.1% azelastine hydrochloride)', 'interventionNames': ['Drug: Astelin Nasal Spray (0.1% azelastine hydrochloride)']}], 'interventions': [{'name': 'Astepro Nasal Spray (0.1% azelastine hydrochloride)', 'type': 'DRUG', 'description': '548 mcg (2 sprays per nostril) twice a day', 'armGroupLabels': ['1']}, {'name': 'Astelin Nasal Spray (0.1% azelastine hydrochloride)', 'type': 'DRUG', 'description': '548 mcg (2 sprays per nostril) twice a day', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08873', 'city': 'Somerset', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Meda Clinical Trials Contact Center', 'geoPoint': {'lat': 40.4976, 'lon': -74.48849}}], 'overallOfficials': [{'name': 'Lewis M. Fredane, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Meda Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meda Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Harry Sacks, MD', 'oldOrganization': 'Vice President, Medical and Scientific Affairs'}}}}