Clinical trial NCT00274053: Effects of a 9-months Treatment of SPIRIVA on Health Related Quality of Life in Patients With COPD
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2006-01-10
Enrollment: 555
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: responder rate on SGRQ questionnaire (% of patients improved by more than 4 points)
Secondary outcomes:
measure: changes in SGRQ scores, VSRQ scores, spirometric parameters (FEV1, FVC, FIV1, SVC, IC) ; incidence, severity and duration of acute exacerbations, PGE
Other outcomes:
Locations:
city: Aix les Bains
country: France
facility: Boehringer Ingelheim Investigational Site
city: Antony
country: France
facility: Hôpital Privé Antony
city: Bordeaux
country: France
facility: Boehringer Ingelheim Investigational Site
city: Cambo les Bains
country: France
facility: Boehringer Ingelheim Investigational Site
city: Cambo les Bains
country: France
facility: Centre Médical Annie Enia
city: Châlons sur Saône
country: France
facility: Boehringer Ingelheim Investigational Site
city: Clermont Ferrand cedex 01
country: France
facility: Hôpital Gabriel Montpied
city: Colmar
country: France
facility: Boehringer Ingelheim Investigational Site
city: Creil
country: France
facility: CH Laennec
city: Dole
country: France
facility: Boehringer Ingelheim Investigational Site
city: Longjumeau
country: France
facility: Centre Hospitalier
city: Luneville
country: France
facility: Boehringer Ingelheim Investigational Site
city: Lyon
country: France
facility: MAPI CRO
city: Maxeville
country: France
facility: Boehringer Ingelheim Investigational Site
city: Metz
country: France
facility: Boehringer Ingelheim Investigational Site
city: Metz
country: France
facility: Hôpital Notre Dame de Bon Secours
city: Montigny les Metz
country: France
facility: Boehringer Ingelheim Investigational Site
city: Mulhouse
country: France
facility: Boehringer Ingelheim Investigational Site
city: Paris
country: France
facility: Hôpital Pitié Salpétrière
city: Paris
country: France
facility: Hôpital Cochin
city: Poitiers
country: France
facility: Boehringer Ingelheim Investigational Site
city: Saint Dié des Vosges
country: France
facility: Hôpital Saint Charles
city: Saint Pierre
country: France
facility: Groupe Hospitalier Sud Réunion
city: Saint Quentin
country: France
facility: Boehringer Ingelheim Investigational Site
city: Toulouse
country: France
facility: Boehringer Ingelheim Investigational Site
city: Toul
country: France
facility: CH Toul
city: Vandoeuvre les Nancy
country: France
facility: Boehringer Ingelheim Investigational Site
Study officials:
affiliation: BI France S.A.S.
name: Boehringer Ingelheim Study Coordinator
role: STUDY_CHAIR
References: