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

Boehringer Ingelheim

Status and phase

Completed

Phase 4

Conditions

Pulmonary Disease, Chronic Obstructive

Treatments

Drug: Olodaterol

Drug: Placebo

Drug: FDC of tiotropium + olodaterol

Drug: Tiotropium

Study type

Interventional

Funder types

Industry

Identifiers

NCT02683109

1237.49

2015-003879-29 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

221 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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.