Measure of the Long Term Influence of SPIRIVA® in Acute Respiratory Disorders
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Purpose
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 |
|---|---|---|
|
Pulmonary Disease, Chronic Obstructive |
Drug: Tiotropium |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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. |
- The primary endpoint was the morning peak expiratory flow rate (PEFR).
- Secondary efficacy endpoints were: incidence, severity and duration of exacerbations number of patients with one or more exacerbation rate of PEFR drops number of lost working days number of days of hospitalisation use of rescue medication, etc
| 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
Eligibility| 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:
- Stable moderate to severe airway obstruction
- Baseline 30 % < FEV1 < 65 % of European Community of Coal and Steel (ECCS) predicted values (R94-1408).
- Baseline FEV1/SVC< 70 %.
- Smoking history > 10 pack-years (p.y.). A p.y. was defined as the equivalent of smoking
- One pack of cigarettes per day for one year.
- History of exacerbation in the past year.
Contacts and Locations
Show 55 Study Locations| Study Chair: | Boehringer Ingelheim Study Coordinator | BI France S.A.S. |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00274014 History of Changes |
| Other Study ID Numbers: | 205.214 |
| Study First Received: | January 9, 2006 |
| Last Updated: | May 11, 2012 |
| Health Authority: | France: AFSSAPS |
Additional relevant MeSH terms:
|
Chronic Disease Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Disease Attributes Pathologic Processes Lung Diseases, Obstructive Tiotropium Parasympatholytics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Bronchodilator Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013