Effects of a 9-months Treatment of SPIRIVA on Health Related Quality of Life in Patients With COPD

Phase 3

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive

• Registration Number: NCT00274053
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The purpose of this study is to investigate the effect of a 9-month treatment of tiotropium (SPIRIVA®) 18 mcg once daily on Health Related Quality of Life and lung function in patients with a Chronic Obstructive Pulmonary Disease.

Detailed Description

This was a multicentre, randomised, double blind, parallel group, placebo-controlled, 9 month study. It was designed to determine the effect of inhaled tiotropium treatment on quality of life in patients with COPD.

Following an initial 2-week screening period, patients were randomized to either tiotropium or placebo at Visit 2. Patients returned to the clinic at month 3 (Visit 3), 6 (Visit 4), and 9 (Visit 5) for the conclusion of the trial. The patients received treatment daily for 9 months.

Quality of life was measured on each visit by using the Saint george's respiratory Questionnaire. Additionally a short form questionnaire was developped for that study (Visual Simplified Respiratory Questionnaire). Lung function was also measured at each visit by spirometry.

Study Hypothesis:

The primary objective of this study is to compare the efficacy of Tiotropium and placebo on improving HRQoL evaluated by the percentage of SGRQ responders. The null hypothesis is that there is no difference in the effect on HRQoL assessed by the percentage of SGRQ responders between the two treatment groups. The alternative hypothesis is that there is a difference in effect on HRQoL assessed by the percentage of SGRQ responders between tiotropium and placebo. The test will be performed at the alpha = 0.05 level of significance.

Comparison(s):

Tiotropium 18 mcg once daily vs Placebo

Study Timeline

• Study Start: 2002-04
• Primary Completion: 2004-04
• Study Completion: 2004-04
• 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: 555

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
responder rate on SGRQ questionnaire (% of patients improved by more than 4 points)

Secondary Outcome Measures

Name	Time	Method
changes in SGRQ scores, VSRQ scores, spirometric parameters (FEV1, FVC, FIV1, SVC, IC) ; incidence, severity and duration of acute exacerbations, PGE

Trial Locations

Locations (13)

CH Laennec; 🇫🇷 Creil, France

Hôpital Pitié Salpétrière; 🇫🇷 Paris, France

Hôpital Privé Antony; 🇫🇷 Antony, France

Hôpital Notre Dame de Bon Secours; 🇫🇷 Metz, France

Groupe Hospitalier Sud Réunion; 🇫🇷 Saint Pierre, France

MAPI CRO; 🇫🇷 Lyon, France

CH Toul; 🇫🇷 Toul, France

Boehringer Ingelheim Investigational Site; 🇫🇷 Vandoeuvre les Nancy, France

Centre Médical Annie Enia; 🇫🇷 Cambo les Bains, France

Hôpital Gabriel Montpied; 🇫🇷 Clermont Ferrand cedex 01, France

Centre Hospitalier; 🇫🇷 Longjumeau, France

Hôpital Cochin; 🇫🇷 Paris, France

Hôpital Saint Charles; 🇫🇷 Saint Dié des Vosges, France