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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00274053
First received: January 9, 2006
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: tiotropium
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

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

Enrollment: 555
Study Start Date: April 2002
Estimated Study Completion Date: April 2004
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00274053

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00274053     History of Changes
Other Study ID Numbers: 205.256
Study First Received: January 9, 2006
Last Updated: October 31, 2013
Health Authority: France: AFSSAPS

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Tiotropium
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014