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)
Verified date | October 2013 |
Source | Boehringer Ingelheim |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: AFSSAPS |
Study type | Interventional |
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.
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Boehringer Ingelheim |
France,
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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