Effect of Tiotropium Inhalation Capsules (Spiriva) on Exercise Tolerance in COPD Patients
NCT ID: NCT00157235
Last Updated: 2017-12-28
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
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COMPLETED
PHASE3
234 participants
INTERVENTIONAL
2002-09-30
2006-04-30
Brief Summary
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Detailed Description
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Following an initial screening, patients will perform a six minute walk test (Visit 1) and enter a 4-week run-in period. Patients will subsequently be randomized to tiotropium or placebo inhalation capsules taken once daily in the morning for the next 25 weeks. After successfully completing 4 weeks of study drug self-administration, patients will enter a period of pulmonary rehabilitation.
Pulmonary rehabilitation will include aerobic lower limb exercise 3 times weekly for 8 weeks. After the last pulmonary rehabilitation session, patients will continue on study medication for a 12 week follow-up period.
Six minute walk tests will be repeated during the run-in period at Week 0 (Visit 2) and Week 4 (Visit 3), at the conclusion of the 8 weeks of pulmonary rehabilitation (Visit 6) and the 12 weeks of follow-up (Visit 9).
Pulmonary function testing will be conducted prior to the start of therapy at Visit 1 and at Visits 2 (week 0 ), 3 (week 4 ), 6 (week 13 ) and 9 (week 25 ).
Study Hypothesis:
The null hypothesis is that there is no difference in the increase in six minute walk distance between tiotropium and placebo groups following 8 weeks pulmonary rehabilitation program. The alternative hypothesis is that tiotropium with pulmonary rehabilitation increases six minute walk distance more than placebo with pulmonary rehabilitation. However, the two-sided test of hypothesis will be performed at 0.05 level of significance.
Comparison(s):
The primary endpoint is the six minute walk distance at visit 6. This endpoint will be compared between tiotropium and placebo using an analysis of covariance model with treatment, center and baseline (six-minute walk distance measured at visit 2 prior to dosing) as a covariate. Fifty-four meters has been determined to be the difference in six minute walk distance between tiotropium (Spiriva, Bromuro de Tiotropio) and placebo at 5% level of significance with at least 80% power using a two-tailed t-test.. .
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Tiotropium bromide
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with a recent history (i.e., 6 months - or less) of myocardial infarction.
* Patients with any cardiac arrhythmia requiring drug therapy in the past year or who have been hospitalized for heart failure within the past three years.
* Patients with symptomatic benign prostatic hypertrophy or bladder neck obstruction.
* Patients with known narrow-angle glaucoma.
40 Years
80 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Principal Investigators
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Boehringer Ingelheim Study Coordinator
Role: STUDY_CHAIR
BI Italy
Locations
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Fondazione "S. Maugeri"
Bari, , Italy
Azienda Sanitaria Locale
Casorate Primo (PV), , Italy
Arcispedale S. Anna
Ferrara, , Italy
U.O. dimedicina Preventiva del Lavoro
Genova, , Italy
Fondazione Maugeri
Gussago (BS), , Italy
Universita degli Studi di Pisa
Pisa, , Italy
Fondazione Don Gnocchi
Pozzolatico (FI), , Italy
Azienda Ospedaliera S. Camillo Forlanini
Roma, , Italy
Fondazione S. Maugeri
Telese Terme (BN), , Italy
Fondazione "S. Maugeri"
Tradate (VA), , Italy
Ospedali Riuniti di Trieste
Trieste, , Italy
Casa di Cura San Raffaele
Velletri (Roma), , Italy
Countries
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Related Links
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Related Info
Other Identifiers
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205.247
Identifier Type: -
Identifier Source: org_study_id