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

Boehringer Ingelheim221 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

221

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

FDC of tiotropium + olodaterolDRUG

Fixed Dose Combination of tiotropium + olodaterol

PlaceboDRUG

TiotropiumDRUG

OlodaterolDRUG

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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.

Locations (22)

Ordination Dr. Robert Voves, 8330 Feldbach

Feldbach, Austria

KH d. Elisabethinen Linz

Linz, Austria

Outcomes

Primary Outcomes

Trough Forced Expiratory Volume in 1 Second (FEV1) (in Liter) After 28 Days of Treatment

This outcome measure presents FEV1 after 28 days of treatment (measurement on Day 29). Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), and was measured at 24 hours (+/- 10 minutes) after trial medication administration at Visit 5. The FEV1 measurement at Visit 4, which was 24 hours after the last open-label run-in treatment intake and 15 minutes before the first double-blind study drug intake was the baseline measurement.

Time frame: Day 29

Secondary Outcomes

Trough Forced Vital Capacity (FVC) (in Liter) After 28 Days of Treatment

This outcome measure presents trough FVC after 28 days of treatment (measurement on Day 29). The FVC measurement at Visit 4, which was 24 hours after the last open-label run-in treatment intake and 15 minutes before the first double-blind study drug intake was the baseline measurement for FVC.

Time frame: Day 29

Chronic Obstructive Pulmonary Disease (COPD) Assessment Test™ (CAT) Score on Day 28

This outcome measure presents COPD assessment test score on Day 28. The COPD Assessment Test™ is a short 8-item questionnaire for assessment and monitoring of COPD health status in routine practice. Its scale is 0-40 (high score = poor health). The CAT measurement on Visit 4 prior to the first dose of double-blind study drug was the baseline for CAT.

Time frame: Day 28

Data from ClinicalTrials.gov

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