Evaluation of the Long- Term Effects of Spiriva on Lung Function in COPD Patients
Evaluation of the Long- Term Effects of Spiriva on Lung Function in COPD Patients
The primary objective of this trial is to determine whether daily treatment with tiotropium
 (Spiriva®, Bromuro de Tiotropio®) inhalation capsule via HandiHaler® reduces the rate of
 decline in lung function over time in patients with COPD.
Inclusion Criteria:

 -  Written informed consent.

 -  Male or female patients 40 years of age or older.

 -  Smoking history of at least 10 pack years.

 -  Diagnosis of COPD with post bronchodilator FEV1 less than or equal to 70% of predicted
 normal and FEV1<70% of FVC and on stable respiratory medication.

 Exclusion Criteria:

 -  Significant diseases other than COPD which in the opinion of the investigator may put
 the patient at risk or influence the patients ability to participate.

 -  Myocardial infarction in past 6 months.

 -  Unstable or life threatening arrhythmia in past year.

 -  Hospitalization for NYHA heart failure class III or IV in past year.

 -  Active tuberculosis.

 -  Asthma.

 -  Pulmonary resection.

 -  Malignancy treated with radiation or chemotherapy in past 5 years.

 -  Respiratory infection in 4 weeks prior to screening.

 -  Known hypersensitivity to anticholinergic drugs or components.

 -  Known moderate to severe renal impairment.

 -  Known narrow angle glaucoma.

 -  Significant symptomatic BPH or bladder neck obstruction.

 -  Need for oxygen therapy >12 hr/day.

 -  Use of oral corticosteroids at unstable doses or >10 mg/day.