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NCT00274053 Clinical Trial

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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:
Effect of a 9-month Treatment of SPIRIVA® on Health Related Quality of Life in Patients With Chronic Obstructive Pulmonary Disease. Validation of a New HRQoL Questionnaire Appropriate to Common Daily Practice. (TIPHON Study)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00274053
Other study ID # 205.256
Secondary ID
Status Completed
Phase Phase 3
First received January 9, 2006
Last updated October 31, 2013
Start date April 2002
Est. completion date April 2004

Study information
Verified date October 2013
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority France: AFSSAPS
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 555
Est. completion date April 2004
Est. primary completion date April 2004
Accepts healthy volunteers No
Gender Both
Age group 40 Years and older
Eligibility Diagnosis of COPD and matching the following criteria:

- Baseline 20 % < FEV1 < 70 % of European Community of Coal and Steel (ECCS) predicted values .

- 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• tiotropium

Locations
Country Name City State
France Boehringer Ingelheim Investigational Site Aix les Bains
France Hôpital Privé Antony Antony
France Boehringer Ingelheim Investigational Site Bordeaux
France Boehringer Ingelheim Investigational Site Cambo les Bains
France Centre Médical Annie Enia Cambo les Bains
France Boehringer Ingelheim Investigational Site Châlons sur Saône
France Hôpital Gabriel Montpied Clermont Ferrand cedex 01
France Boehringer Ingelheim Investigational Site Colmar
France CH Laennec Creil
France Boehringer Ingelheim Investigational Site Dole
France Centre Hospitalier Longjumeau
France Boehringer Ingelheim Investigational Site Luneville
France MAPI CRO Lyon
France Boehringer Ingelheim Investigational Site Maxeville
France Boehringer Ingelheim Investigational Site Metz
France Hôpital Notre Dame de Bon Secours Metz
France Boehringer Ingelheim Investigational Site Montigny les Metz
France Boehringer Ingelheim Investigational Site Mulhouse
France Hôpital Cochin Paris
France Hôpital Pitié Salpétrière Paris
France Boehringer Ingelheim Investigational Site Poitiers
France Hôpital Saint Charles Saint Dié des Vosges
France Groupe Hospitalier Sud Réunion Saint Pierre
France Boehringer Ingelheim Investigational Site Saint Quentin
France CH Toul Toul
France Boehringer Ingelheim Investigational Site Toulouse
France Boehringer Ingelheim Investigational Site Vandoeuvre les Nancy

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary responder rate on SGRQ questionnaire (% of patients improved by more than 4 points)
Secondary changes in SGRQ scores, VSRQ scores, spirometric parameters (FEV1, FVC, FIV1, SVC, IC) ; incidence, severity and duration of acute exacerbations, PGE
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