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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00523991 |
A 24 week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 18mcg of tiotropium inhalation capsules administered by Handihaler once daily plus PRN albuterol (salbutamol) vs. placebo plus PRN albuterol (salbutamol) in chronic obstructive pulmonary disease subjects naive to maintenance therapy.
Condition | Intervention | Phase |
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Pulmonary Disease, Chronic Obstructive |
Drug: tiotropium inhalation capsules |
Phase IV |
Study Type: | Interventional |
Study Design: | Parallel Assignment, Safety/Efficacy Study |
Official Title: | A 24 Week, Randomized, Double-Blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of 18 MCG of Tiotropium Inhalation Capsules Administered by HandiHaler Once-Daily Plus PRN Albuterol (Salbutamol) vs. Placebo Plus PRN Albuterol (Salbutamol) in Chronic Obstructive Pulmonary Disease Subjects Naive to Maintenance Therapy |
Estimated Enrollment: | 436 |
Study Start Date: | April 2007 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 40 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Boehringer Ingelheim Study Coordinator | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 205.365, 2006-006276-38, A4471008 |
Study First Received: | July 9, 2007 |
Last Updated: | May 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00523991 History of Changes |
Health Authority: | Belgium: Federal Agency for Medicines and Health Products; Canada: Health Canada - Therapeutic Products Directorate; Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10; Germany: Federal Institute for Drugs and Medical Devices; Great Britain: MHRA; Greece: National Organization of Medicines (EOF); Netherlands: Central Committee on Research involving Human Subjects (CCMO); Portugal: INFARMED - National Authority of Medicines and Health Products, IP; Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine); United States: Food and Drug Administration |
Neurotransmitter Agents Cholinergic Antagonists Respiration Disorders Albuterol Anti-Asthmatic Agents Cholinergic Agents Lung Diseases, Obstructive |
Respiratory Tract Diseases Lung Diseases Chronic Disease Peripheral Nervous System Agents Tiotropium Bronchodilator Agents Pulmonary Disease, Chronic Obstructive |
Respiratory System Agents Parasympatholytics Neurotransmitter Agents Disease Attributes Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Respiration Disorders Physiological Effects of Drugs Anti-Asthmatic Agents Cholinergic Agents Pharmacologic Actions |
Lung Diseases, Obstructive Pathologic Processes Respiratory Tract Diseases Autonomic Agents Therapeutic Uses Lung Diseases Chronic Disease Peripheral Nervous System Agents Tiotropium Bronchodilator Agents Pulmonary Disease, Chronic Obstructive |