Effects of a 9-months Treatment of SPIRIVA on Health Related Quality of Life in Patients With COPD
NCT ID: NCT00274053
Last Updated: 2013-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
555 participants
INTERVENTIONAL
2002-04-30
2004-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
tiotropium
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion 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.
40 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boehringer Ingelheim
INDUSTRY
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Boehringer Ingelheim Study Coordinator
Role: STUDY_CHAIR
BI France S.A.S.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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, , 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
Lunéville, , France
MAPI CRO
Lyon, , France
Boehringer Ingelheim Investigational Site
Maxéville, , France
Boehringer Ingelheim Investigational Site
Metz, , France
Hôpital Notre Dame de Bon Secours
Metz, , France
Boehringer Ingelheim Investigational Site
Montigny-lès-Metz, , France
Boehringer Ingelheim Investigational Site
Mulhouse, , France
Hôpital Pitié Salpétrière
Paris, , France
Hôpital Cochin
Paris, , France
Boehringer Ingelheim Investigational Site
Poitiers, , France
Hôpital Saint Charles
Saint-Dié, , 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
Vandœuvre-lès-Nancy, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
205.256
Identifier Type: -
Identifier Source: org_study_id