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

Boehringer Ingelheim logo

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

221 participants in 2 patient groups

FDC of tiotropium + olodaterol
Experimental group
Description:
Fixed Dose Combination of tiotropium + olodaterol
Treatment:
Drug: FDC of tiotropium + olodaterol
Drug: Placebo
Free combination tiotropium + olodaterol
Active Comparator group
Treatment:
Drug: Tiotropium
Drug: Olodaterol

Trial contacts and locations

22

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Data sourced from clinicaltrials.gov

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