• The primary endpoint is the change from baseline (Visit 2) in six minute walk distance after 8 weeks of pulmonary rehabilitation ( Visit 6).
  

• Individual FEV1 and FVC measurements at each timepoint Saint George's Hospital Respiratory Questionnaire.Transition Dyspnea I
  

This is an 25-week multicenter, single country, randomised, double-blind, placebo-controlled, parall el group study to compare the efficacy of tiotropium inhalation capsules (Spiriva, Bromuro de Tiotro pio) 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 week s 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. Afte r the last pulmonary rehabilitation session, patients will continue on study medication for a 12 wee k follow-up period. Six minute walk tests will be repeated during the run-in period at Week 0 (Visit 2) and Week 4 (Vis it 3), at the conclusion of the 8 weeks of pulmonary rehabilitation (Visit 6) and the 12 weeks of fo llow-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 pul monary rehabilitation increases six minute walk distance more than placebo with pulmonary rehabilitation. However, the two-sided test of hypothesis will be per formed at 0.05 level of significance.

Comparison(s):

The primary endpoint is the six minute walk distance at visit 6. This endpoint w ill be compared between tiotropium and placebo using an analysis of covariance m odel with treatment, center and baseline (six-minute walk distance measured at v isit 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, Brom uro de Tiotropio) and placebo at 5% level of significance with at least 80% powe r using a two-tailed t-test.. .

Inclusion Criteria:

COPD patients with FEV1 less 60% of predicted FEV1 less 70% of FVC.

Exclusion Criteria:

• Patients with any respiratory infection in the six weeks prior to the Screenin g Visit or during the run-in period (between Visits 1 and 2).
• Patients with a recent history (i.e., 6 months - or less) of myocardial infarc tion.
• Patients with any cardiac arrhythmia requiring drug therapy in the past year o r who have been hospitalised for heart failure within the past three years.
• Patients with symptomatic benign prostatic hypertrophy or bladder neck bstruct ion.
• Patients with known narrow-angle glaucoma.