Effect of Tiotropium Inhalation Capsules (Spiriva) on Exercise Tolerance in COPD Patients
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this trial is to determine whether tiotropium inhalation capsules (Spiriva,
      Bromuro de Tiotropio), compared to placebo, enhances the improvement in exercise tolerance
      seen in patients with chronic obstructive pulmonary disease (COPD) who participate in
      pulmonary rehabilitation.
    

Detailed description: 
      This is an 25-week multicenter, single country, randomised, double-blind, placebo-controlled,
      parallel group study to compare the efficacy of tiotropium inhalation capsules (Spiriva,
      Bromuro de Tiotropio) in patients with COPD participating in a pulmonary rehabilitation
      program.

      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.. .
    

Intervention name(s): Tiotropium bromide
Intervention type(s): Drug
Intervention MeSH terms: Bromides; Tiotropium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment