Effects of a 9-months Treatment of SPIRIVA on Health Related Quality of Life in Patients With COPD
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| ClinicalTrials.gov Identifier: NCT00274053 |
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Recruitment Status
:
Completed
First Posted
: January 10, 2006
Last Update Posted
: November 1, 2013
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pulmonary Disease, Chronic Obstructive | Drug: tiotropium | Phase 3 |
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
| 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 |
- responder rate on SGRQ questionnaire (% of patients improved by more than 4 points)
- 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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| 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.
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 ClinicalTrials.gov identifier (NCT number): NCT00274053
| France | |
| 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 | |
| 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 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 | |
| Study Chair: | Boehringer Ingelheim Study Coordinator | BI France S.A.S. |
| ClinicalTrials.gov 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:
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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 Parasympatholytics Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |