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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00274014 |
The objectives of this study were to evaluate the effect of a one-year treatment with inhaled tiotropium bromide 18 mcg once daily on lung function, incidence and severity of exacerbations in patients with chronic obstructive pulmonary disease (COPD). The secondary purpose was to explore possible relationships between lung function changes and occurrence of COPD exacerbations and to try to characterize these exacerbations.
Condition | Intervention | Phase |
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Pulmonary Disease, Chronic Obstructive |
Drug: Tiotropium |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Effects of Inhaled Tiotropium Bromide on Severity of Airflow Obstruction During Long-Term Treatment in Patients With Moderately Severe Copd. Impact on Severity and Incidence of Exacerbations. |
Estimated Enrollment: | 1000 |
Study Start Date: | October 2000 |
Estimated Study Completion Date: | October 2003 |
This was a multicentre, randomised, double blind, parallel group, placebo-controlled, one year study. It was designed to determine the effect of inhaled tiotropium treatment on airflow obstruction (PEFR), incidence and severity of exacerbations in patients with COPD. Following an initial 3-week screening period qualifying patients were randomized to either tiotropium or placebo at Visit 2. Patients returned to the clinic at weeks 6 (Visit 3), 12 (Visit 4), 24 (Visit 5), 36 (Visit 6), 48 (Visit 7) and at Week 50 for the conclusion of the trial (Visit 8). The patients received treatment daily for 48 weeks (336 days). PEFR, as well as use of rescue medication and respiratory condition, were self-assessed by patients and recorded every morning on a graphical diary card every morning. The graphical presentation of these data was supposed to help investigators to detect exacerbations occurring between two consecutive visits. Details on hospitalizations due to COPD exacerbations were recorded in a special hospitalization booklet.
Study Hypothesis:
The objectives of this study were to evaluate the effect of a one-year treatment with inhaled tiotropium bromide 18 mcg once daily on lung function, incidence and severity of exacerbations in patients with chronic obstructive pulmonary disease (COPD). The secondary purpose was to explore possible relationships between lung function changes and occurrence of COPD exacerbations and to try to characterize these exacerbations.
Comparison(s):
Tiotropium 18 mcg once daily vs Placebo
Ages Eligible for Study: | 41 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Diagnosis of COPD according to the European Respiratory Society (ERS) (R95-3225) and matching the following criteria:
Study Chair: | Boehringer Ingelheim Study Coordinator | BI France S.A.S. |
Study ID Numbers: | 205.214 |
Study First Received: | January 9, 2006 |
Last Updated: | July 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00274014 History of Changes |
Health Authority: | France: AFSSAPS |
Neurotransmitter Agents Cholinergic Antagonists Respiration Disorders Anti-Asthmatic Agents Cholinergic Agents Lung Diseases, Obstructive Respiratory Tract Diseases |
Bromides 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 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 |