Effects of a 9-months Treatment of SPIRIVA on Health Related Quality of Life in Patients With COPD
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
tiotropium
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive
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.
Sites / Locations
- Boehringer Ingelheim Investigational Site
- Hôpital Privé Antony
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Centre Médical Annie Enia
- Boehringer Ingelheim Investigational Site
- Hôpital Gabriel Montpied
- Boehringer Ingelheim Investigational Site
- CH Laennec
- Boehringer Ingelheim Investigational Site
- Centre Hospitalier
- Boehringer Ingelheim Investigational Site
- MAPI CRO
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Hôpital Notre Dame de Bon Secours
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- Hôpital Pitié Salpétrière
- Hôpital Cochin
- Boehringer Ingelheim Investigational Site
- Hôpital Saint Charles
- Groupe Hospitalier Sud Réunion
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
- CH Toul
- Boehringer Ingelheim Investigational Site
Outcomes
Primary Outcome Measures
responder rate on SGRQ questionnaire (% of patients improved by more than 4 points)
Secondary Outcome Measures
changes in SGRQ scores, VSRQ scores, spirometric parameters (FEV1, FVC, FIV1, SVC, IC) ; incidence, severity and duration of acute exacerbations, PGE
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00274053
Brief Title
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
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
April 2004 (Actual)
Study Completion Date
April 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
555 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
tiotropium
Primary Outcome Measure Information:
Title
responder rate on SGRQ questionnaire (% of patients improved by more than 4 points)
Secondary Outcome Measure Information:
Title
changes in SGRQ scores, VSRQ scores, spirometric parameters (FEV1, FVC, FIV1, SVC, IC) ; incidence, severity and duration of acute exacerbations, PGE
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim Study Coordinator
Organizational Affiliation
BI France S.A.S.
Official's Role
Study Chair
Facility Information:
Facility Name
Boehringer Ingelheim Investigational Site
City
Aix les Bains
ZIP/Postal Code
73100
Country
France
Facility Name
Hôpital Privé Antony
City
Antony
ZIP/Postal Code
92166
Country
France
Facility Name
Boehringer Ingelheim Investigational Site
City
Bordeaux
ZIP/Postal Code
33100
Country
France
Facility Name
Boehringer Ingelheim Investigational Site
City
Cambo les Bains
ZIP/Postal Code
64250
Country
France
Facility Name
Centre Médical Annie Enia
City
Cambo les Bains
ZIP/Postal Code
64250
Country
France
Facility Name
Boehringer Ingelheim Investigational Site
City
Châlons sur Saône
ZIP/Postal Code
71100
Country
France
Facility Name
Hôpital Gabriel Montpied
City
Clermont Ferrand cedex 01
ZIP/Postal Code
63003
Country
France
Facility Name
Boehringer Ingelheim Investigational Site
City
Colmar
ZIP/Postal Code
68000
Country
France
Facility Name
CH Laennec
City
Creil
ZIP/Postal Code
60109
Country
France
Facility Name
Boehringer Ingelheim Investigational Site
City
Dole
ZIP/Postal Code
39100
Country
France
Facility Name
Centre Hospitalier
City
Longjumeau
ZIP/Postal Code
91160
Country
France
Facility Name
Boehringer Ingelheim Investigational Site
City
Luneville
ZIP/Postal Code
54300
Country
France
Facility Name
MAPI CRO
City
Lyon
ZIP/Postal Code
69003
Country
France
Facility Name
Boehringer Ingelheim Investigational Site
City
Maxeville
ZIP/Postal Code
54320
Country
France
Facility Name
Boehringer Ingelheim Investigational Site
City
Metz
ZIP/Postal Code
57000
Country
France
Facility Name
Hôpital Notre Dame de Bon Secours
City
Metz
ZIP/Postal Code
57038
Country
France
Facility Name
Boehringer Ingelheim Investigational Site
City
Montigny les Metz
ZIP/Postal Code
57950
Country
France
Facility Name
Boehringer Ingelheim Investigational Site
City
Mulhouse
ZIP/Postal Code
68100
Country
France
Facility Name
Hôpital Pitié Salpétrière
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Hôpital Cochin
City
Paris
ZIP/Postal Code
75679
Country
France
Facility Name
Boehringer Ingelheim Investigational Site
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
Hôpital Saint Charles
City
Saint Dié des Vosges
ZIP/Postal Code
88187
Country
France
Facility Name
Groupe Hospitalier Sud Réunion
City
Saint Pierre
ZIP/Postal Code
97448
Country
France
Facility Name
Boehringer Ingelheim Investigational Site
City
Saint Quentin
ZIP/Postal Code
02100
Country
France
Facility Name
Boehringer Ingelheim Investigational Site
City
Toulouse
ZIP/Postal Code
31300
Country
France
Facility Name
CH Toul
City
Toul
ZIP/Postal Code
54201
Country
France
Facility Name
Boehringer Ingelheim Investigational Site
City
Vandoeuvre les Nancy
ZIP/Postal Code
54500
Country
France
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.256_U05-1961.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.256_literature.pdf
Description
Related Info
Learn more about this trial
Effects of a 9-months Treatment of SPIRIVA on Health Related Quality of Life in Patients With COPD
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