Fixed Dose Combination Versus Free Combination of Tiotropium and Olodaterol in COPD

• Status: Completed
• Trial end date: 2017-01-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a 4-week, multicenter, randomized, double-blind, parallel group and active controlled study.

Patients will be randomized (1 to 1 ratio) to a 4-week double-blind treatment period of either FDC (fixed-dose combination) of tiotropium + olodaterol (5/5 µg) plus placebo or the free combination of tiotropium 5 µg and olodaterol 5 µg; all administered via the Respimat® inhaler. The purpose is to show non-inferiority between the FDC and the free combination of tiotropium and olodaterol in patients with COPD.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Olodaterol; Tiotropium Bromide

Criteria

Inclusion criteria:

• Male or female patients.

• Patients 40 years of age or older.

• Patients with a smoking history > 10 pack years.

• Diagnostic of COPD with Post-bronchodilator FEV1 (Forced Expiratory Volume in one second) >= 30% and <80% of predicted normal and Post-bronchodilator FEV1/FVC (Forced Vital Capacity) <70% at screening.

• Symptomatic patients with CAT (COPD Assessment Test TM) score >= 10 at screening.

• Further inclusion criteria apply.

Exclusion criteria:

• COPD exacerbation or symptoms of lower respiratory tract infection within 6 weeks prior to screening.

• Patients with a current diagnosis of asthma.

• Further exclusion criteria apply.