Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-26 @ 1:21 AM
Study NCT ID:
NCT00242333
Status:
COMPLETED
Last Update Posted:
2006-05-16
First Post:
2005-10-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Assess the Safety and Efficacy of Different AD 237 Doses in Adults With COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D004646', 'term': 'Emphysema'}, {'id': 'D029481', 'term': 'Bronchitis, Chronic'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-05', 'lastUpdateSubmitDate': '2006-05-15', 'studyFirstSubmitDate': '2005-10-19', 'studyFirstSubmitQcDate': '2005-10-19', 'lastUpdatePostDateStruct': {'date': '2006-05-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pulmonary function'}], 'secondaryOutcomes': [{'measure': 'Pulmonary function'}]}, 'conditionsModule': {'keywords': ['COPD', 'COAD', 'Chronic obstructive pulmonary disease', 'emphysema', 'chronic bronchitis'], 'conditions': ['COPD']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the efficacy, safety and tolerability of AD 237 in patients with chronic obstructive pulmonary disease (COPD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with COPD, with symptoms of cough and chronic sputum production and/or dyspnea.\n* Post-bronchodilator FEV1 at no more than 65% and at least 30% of the predicted normal value.\n* Pre-bronchodilator FEV1/FVC ratio of less than 70%.\n* Current or ex-smokers with a smoking history of at least 10 pack years.\n\nExclusion Criteria:\n\n* History of asthma, atopy or allergic rhinitis.\n* Other serious respiratory or other medical conditions which may interfere with the outcome of the study.'}, 'identificationModule': {'nctId': 'NCT00242333', 'briefTitle': 'A Study to Assess the Safety and Efficacy of Different AD 237 Doses in Adults With COPD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sosei'}, 'officialTitle': 'A Multi-Center Randomized, Double-Blind, Parallel Group, Placebo Controlled Study, Including an Additional Open Label Tiotropium Group, to Assess the Efficacy, Safety and Tolerability of 4 Doses of AD 237 Inhaled Once Daily for 28 Days in Subjects With COPD.', 'orgStudyIdInfo': {'id': 'P-AD237-005'}}, 'armsInterventionsModule': {'interventions': [{'name': 'AD 237', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'Specialized Hospital for Active Treatment Pneumophthysiatric Disease "Kudoglu"', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'zip': '7002', 'city': 'Rousse', 'country': 'Bulgaria', 'facility': 'Regional Dispensary for Pulmonary Diseases Rousse', 'geoPoint': {'lat': 43.84872, 'lon': 25.9534}}, {'zip': '1233', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': '5-th Multiprofile Hospital for Active Treatment', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1431', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'MHAT "Alexandrovska"', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1431', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Specialized Hospital for Active Treatment of Pulmonary Diseases "Sveta Sofia"', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1606', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Central Clinical Base - Medical Institute - Ministry of the Interior', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1606', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Military Medical Academy', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '6003', 'city': 'Stara Zagora', 'country': 'Bulgaria', 'facility': 'UMHAT "Stara Zagora" EAD', 'geoPoint': {'lat': 42.43205, 'lon': 25.64262}}, {'zip': '9010', 'city': 'Varna', 'country': 'Bulgaria', 'facility': 'University Hospital', 'geoPoint': {'lat': 43.21912, 'lon': 27.91024}}, {'zip': '2661', 'city': 'Balassagyarmat', 'country': 'Hungary', 'facility': 'Tudogyintezete Nodradgardony', 'geoPoint': {'lat': 48.07296, 'lon': 19.29614}}, {'zip': '1033', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'III. district Outpatient Clinic', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '1036', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Diagnostic Units Hungary Ltd', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '1221', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Gyogyir XI. Kht.II. 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Stefan"', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '20125', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Spitalul Clinic "Colentina"', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '21105', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Institutul National de Boli Infectioase', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '30317', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Spitalul Clinic de Boli Infectioase si Tropicale " Dr. Victor Babes "', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '50159', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Institutul de Pneumologie " Marius Nasta "', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '900591', 'city': 'Constanța', 'country': 'Romania', 'facility': 'Spitalul Clinic de Urgenta Constanta', 'geoPoint': {'lat': 44.18073, 'lon': 28.63432}}], 'overallOfficials': [{'name': 'Robert G Tansley, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Arakis Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sosei', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Novartis', 'class': 'INDUSTRY'}]}}}