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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00274053
Recruitment Status : Completed
First Posted : January 10, 2006
Last Update Posted : November 1, 2013
Information provided by:
Boehringer Ingelheim

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.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: tiotropium Phase 3

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.


Tiotropium 18 mcg once daily vs Placebo

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 555 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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)
Study Start Date : April 2002
Actual Primary Completion Date : April 2004
Study Completion Date : April 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
U.S. FDA Resources

Primary Outcome Measures :
  1. responder rate on SGRQ questionnaire (% of patients improved by more than 4 points)

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00274053

Boehringer Ingelheim Investigational Site
Aix les Bains, France, 73100
Hôpital Privé Antony
Antony, France, 92166
Boehringer Ingelheim Investigational Site
Bordeaux, France, 33100
Boehringer Ingelheim Investigational Site
Cambo les Bains, France, 64250
Centre Médical Annie Enia
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
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 Pitié Salpétrière
Paris, France, 75013
Hôpital Cochin
Paris, France, 75679
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
Boehringer Ingelheim Investigational Site
Toulouse, France, 31300
CH Toul
Toul, France, 54201
Boehringer Ingelheim Investigational Site
Vandoeuvre les Nancy, France, 54500
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Study Coordinator BI France S.A.S. Identifier: NCT00274053     History of Changes
Other Study ID Numbers: 205.256
First Posted: January 10, 2006    Key Record Dates
Last Update Posted: November 1, 2013
Last Verified: October 2013

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