Efficacy and Safety Comparison of Tiotropium Inhalation Solution (Respimat Inhaler) and Spiriva HandiHaler in Chronic Obstructive Pulmonary Disease (COPD)

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Tiotropium; Device: Respimat SMI; Device: HandiHaler

Study type: Interventional

Funder types: Industry

Identifiers

NCT00281567

205.250

Details and patient eligibility

About

Comparison of lung function response between tiotropium inhalation solution and Spiriva HandiHaler.

Enrollment: 76 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of COPD
• FEV1 < 60% predicted
• FEV1 < 70% of FVC
• Smoking history of 10 pack-years

Exclusion criteria

• Significant other disease than COPD
• Recent history of MI (1 year or less)
• Cardiac arrhythmia requiring drug therapy
• History of asthma, allergic rhinitis or eosinophil count > 600 mm3
• Symptomatic prostatic hypertrophy or bladder neck obstruction
• Known narrow-angle glaucoma
• Abnormal baseline hematology, blood chemistry or urinalysis
• History of cancer within last 5 years
• Life-threatening pulmonary obstruction
• Cystic fibrosis or bronchiectasis
• Tuberculosis
• Pulmonary resection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind