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

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: tiotropium; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00144339

205.235

Details and patient eligibility

About

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.

Enrollment: 5,993 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.