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

October 31, 2013 updated by: Boehringer Ingelheim

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)

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.

Study Overview

Status

Completed

Conditions

Pulmonary Disease, Chronic Obstructive

Intervention / Treatment

Drug: tiotropium

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 Type

Interventional

Enrollment (Actual)

555

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Aix les Bains, France, 73100
    - Boehringer Ingelheim Investigational Site
  - Antony, France, 92166
    - Hôpital Privé Antony
  - Bordeaux, France, 33100
    - Boehringer Ingelheim Investigational Site
  - Cambo les Bains, France, 64250
    - Boehringer Ingelheim Investigational Site
  - Cambo les Bains, France, 64250
    - Centre Médical Annie Enia
  - Châlons sur Saône, France, 71100
    - Boehringer Ingelheim Investigational Site
  - Clermont Ferrand cedex 01, France, 63003
    - Hôpital Gabriel Montpied
  - Colmar, France, 68000
    - Boehringer Ingelheim Investigational Site
  - Creil, France, 60109
    - Ch Laennec
  - Dole, France, 39100
    - Boehringer Ingelheim Investigational Site
  - Longjumeau, France, 91160
    - Centre Hospitalier
  - Luneville, France, 54300
    - Boehringer Ingelheim Investigational Site
  - Lyon, France, 69003
    - MAPI CRO
  - Maxeville, France, 54320
    - Boehringer Ingelheim Investigational Site
  - Metz, France, 57000
    - Boehringer Ingelheim Investigational Site
  - Metz, France, 57038
    - Hôpital Notre Dame de Bon Secours
  - Montigny les Metz, France, 57950
    - Boehringer Ingelheim Investigational Site
  - Mulhouse, France, 68100
    - Boehringer Ingelheim Investigational Site
  - Paris, France, 75679
    - Hôpital Cochin
  - Paris, France, 75013
    - Hôpital Pitie Salpétrière
  - Poitiers, France, 86000
    - Boehringer Ingelheim Investigational Site
  - Saint Dié des Vosges, France, 88187
    - Hôpital Saint Charles
  - Saint Pierre, France, 97448
    - Groupe Hospitalier Sud Réunion
  - Saint Quentin, France, 02100
    - Boehringer Ingelheim Investigational Site
  - Toul, France, 54201
    - CH Toul
  - Toulouse, France, 31300
    - Boehringer Ingelheim Investigational Site
  - Vandoeuvre les Nancy, France, 54500
    - Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
responder rate on SGRQ questionnaire (% of patients improved by more than 4 points)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Primary Completion (Actual)

April 1, 2004

Study Completion

April 1, 2004

Study Registration Dates

First Submitted

January 9, 2006

First Submitted That Met QC Criteria

January 9, 2006

First Posted (Estimate)

January 10, 2006

Study Record Updates

Last Update Posted (Estimate)

November 1, 2013

Last Update Submitted That Met QC Criteria

October 31, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

205.256

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.