Evaluation of the Long- Term Effects of Spiriva on Lung Function in COPD Patients

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Tiotropium Bromide

Criteria

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.