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

Phase 3

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive

• Registration Number: NCT00274014
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

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

Study Timeline

• Study Start: 2000-10
• Primary Completion: 2003-10
• Study Completion: 2003-10
• Study First Submitted: 2006-01-09
• Study First Submitted QC: 2006-01-09
• Study First Posted: 2006-01-10
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-31
• Last Update Posted: 2013-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
morning peak expiratory flow rate (PEFR)	50 weeks

Secondary Outcome Measures

Name	Time	Method
use of rescue medications, type and duration	50 weeks
plethysmography (RV, TLC) (optional)	50 weeks
spirometric evaluation (FEV1, FVC, SVC, MEF25-75 ) and optional measurements (IC)	50 weeks
Adverse events, physical examination	50 weeks
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
bacterial and viral characterisation of severe exacerbations	50 weeks
number of days of hospitalisation	50 weeks

Trial Locations

Locations (41)

Clinique Saint Sauveur; 🇫🇷 Angers, France

Boehringer Ingelheim Investigational Site; 🇫🇷 Sélestat, France

Clinique la Casamance; 🇫🇷 Aubagne, France

Hôpital; 🇫🇷 Bois Guillaume cedex, France

GPL; 🇫🇷 Caluire, France

CH Cholet; 🇫🇷 Cholet, France

Hôpital Gabriel Montpied; 🇫🇷 Clermont-Ferrand cedex 1, France

Clinique des Cèdres; 🇫🇷 Cornebarrieu, France

Clinique Saint Vincent; 🇫🇷 Epernay, France

Centre Hospitalier Auban Moet; 🇫🇷 Epernay, France

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