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Sponsors and Collaborators: |
Novartis Pacira Pharmaceuticals, Inc |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00134979 |
This study is not being conducted in the United States.
This study is designed to provide efficacy and safety data for formoterol 10µg twice-a-day (b.i.d.) delivered by the Certihaler in patients with chronic obstructive pulmonary disease (COPD). This study is also designed to compare the efficacy and safety of therapy with formoterol (Certihaler)10µg b.i.d. added to tiotropium (HandiHaler) 18µg once daily (o.d.) compared with tiotropium (HandiHaler) 18µg o.d. monotherapy, and to compare the safety and efficacy of formoterol 10µg b.i.d. (Certihaler) with tiotropium 18µg o.d. (HandiHaler).
Condition | Intervention | Phase |
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Chronic Obstructive Pulmonary Disease |
Drug: Formoterol |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Efficacy and Safety of Formoterol Certihaler, Tiotropium HandiHaler and Tiotropium HandiHaler in Combination With Formoterol Certihaler in Patients With Stable Chronic Obstructive Pulmonary Disease |
Estimated Enrollment: | 800 |
Study Start Date: | October 2004 |
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CFOR258F2402 |
Study First Received: | July 26, 2005 |
Last Updated: | October 18, 2006 |
ClinicalTrials.gov Identifier: | NCT00134979 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices; Brazil: National Health Surveillance Agency; Czech Republic: State Institute for Drug Control; Hungary: National Institute of Pharmacy; Italy: Ministry of Health; Netherlands: Medicines Evaluation Board (MEB); Poland: Ministry of Health; Russia: Pharmacological Committee, Ministry of Health; Spain: Spanish Agency of Medicines |
COPD, formoterol, |
Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Respiration Disorders |
Formoterol Tiotropium Pulmonary Disease, Chronic Obstructive |
Parasympatholytics Respiratory System Agents Neurotransmitter Agents Cholinergic Antagonists Adrenergic beta-Agonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
Anti-Asthmatic Agents Cholinergic Agents Adrenergic Agonists Pharmacologic Actions Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents |