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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
---|---|
Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00144339 |
The primary objective of this trial is to determine whether daily treatment with tiotropium (Spiriva®, Bromuro de Tiotropio®) inhalation capsule via HandiHaler® reduces the rate of decline in lung function over time in patients with COPD.
Condition | Intervention | Phase |
---|---|---|
Pulmonary Disease, Chronic Obstructive |
Drug: tiotropium |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial Assessing the Rate of Decline of Lung Function With Tiotropium 18 Mcg Inhalation Capsule Once Daily in Patients With Chronic Obstructive Pulmonary Disease (COPD). |
Enrollment: | 5993 |
Study Start Date: | December 2002 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Written informed consent, male or female patients 40 years of age or older, smoking history of at least 10 pack years, diagnosis of COPD with post bronchodilator FEV1 less than or equal to 70% of predicted normal and FEV1<70% of FVC and on stable respiratory medication
Exclusion Criteria:
Significant diseases other than COPD which in the opinion of the investigator may put the patient at risk or influence the patients ability to participate, Mi in past 6 months, unstable or life threatening arrhythmia in past year, hospitalization for NYHA heart failure class III or IV in past year, active TB, asthma, pulmonary resection, malignancy treated with radiation or chemotherapy in past 5 years, respiratory infection in 4 weeks prior to screening, known hypersensitivity to anticholinergic drugs or components, known moderate to severe renal impairment, known narrow angle glaucoma, significant symptomatic BPH or bladder neck obstruction, need for oxygen therapy >12 hr/day, use of oral corticosteroids at unstable doses or >10 mg/day
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 205.235 |
Study First Received: | September 2, 2005 |
Last Updated: | October 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00144339 |
Health Authority: | Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10; Hungary: National Institute of Pharmacy, H-1051 Budapest; Lithuania: State Medicines Control Agency, LT-01132 Vilnius; Poland: Urzad Rejestracji Produktow Leczniczych, Wyrobow, Medycznych i Produktow Biobojczych; Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow; Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26; Slovenia: Agency for Medicinal Products, SI-1000 Ljubljana; Australia: Responsilble Ethics Committee; New Zealand: Multicentre Ethics Committee/Medsafe; Austria: Bundesamt für Sicherheit im Gesundheitswesen, A-1030 Vienna; Belgium: Federal Agency for Medicines and Health Products; United States: Food and Drug Administration; France: AFFSAPS; Hong Kong: Dept. of Health of Hong Kong; Italy: Comitato Etico Az. Osp. Univ. Pisana di Pisa; Malaysia: Ministry of Health, Malaysia; Norway: Norwegian Medicines Agency (Statens Legemiddelverk); Portugal: INFARMED - National Authority of Medicines and Health Products, IP; Argentina: A.N.M.A.T. (Administracion Nacional de Medicamentos, Alimentos y Tecnología); Taiwan: Department of Health, Executive Yuan, Taiwan; Philippines: Department of Health, Republic of the Philippines; Thailand: Ministry of Public Health; Finland: National Agency for Medicines; Singapore: Health Science Authority, Ministry of Health; Switzerland: Swissmedic; Turkey: Ministry of Health Central Ethics Committee; Great Britain: MHRA; South Africa: Medicines Control Council |
Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Respiration Disorders |
Chronic Disease Tiotropium Pulmonary Disease, Chronic Obstructive |
Respiratory System Agents Parasympatholytics Disease Attributes Neurotransmitter Agents Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Asthmatic Agents |
Cholinergic Agents Pharmacologic Actions Pathologic Processes Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents |