Measure of the Long Term Influence of SPIRIVA® in Acute Respiratory Disorders

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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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.

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Drug: Tiotropium


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 41 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tiotropium|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morning peak expiratory flow rate (PEFR) |  | 50 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence, severity and duration of exacerbations |  | 50 weeks | 
| number of patients with one or more exacerbation |  | 50 weeks | 
| rate of PEFR drops |  | 50 weeks | 
| number of lost working days |  | 50 weeks | 
| number of days of hospitalisation |  | 50 weeks | 
| use of rescue medications, type and duration |  | 50 weeks | 
| bacterial and viral characterisation of severe exacerbations |  | 50 weeks | 
| spirometric evaluation (FEV1, FVC, SVC, MEF25-75 ) and optional measurements (IC) |  | 50 weeks | 
| plethysmography (RV, TLC) (optional) |  | 50 weeks | 
| Adverse events, physical examination |  | 50 weeks |