Fixed dose combination versus free combination of tiotropium and olodaterol in COPD

A 4-week, randomised, double-blind, parallel group study to evaluate the efficacy and safety of tiotropium + olodaterol fixed dose combination (5/5 µg) delivered by the Respimat® inhaler versus the free combination of tiotropium 5 µg and olodaterol 5 µg delivered by separate Respimat® inhalers in patients with chronic obstructive pulmonary disease (COPD) - Fixed dose combination versus free combination of tiotropium and olodaterol in COPD

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003879-29-FI

Enrollment

350

Registered

2015-11-27

Start date

2015-12-30

Completion date

Unknown

Last updated

2017-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease MedDRA version: 19.0 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855

Interventions

Trade Name: Spiolto Respimat 2.5 microgram/2.5 microgram, inhalation solution Product Name: Tiotropium 2.5 µg/Olodaterol 2.5µg Pharmaceutical Form: Inhalation solution INN or Proposed INN: Tiotropium

Eligibility

Sex/Gender

All

Inclusion 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 >= 30% and = 10 at screening. - Further inclusion criteria apply. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 110 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 110

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of this study is to show that the FDC of tiotropium + olodaterol (5/5 µg) is non inferior to the free combination of its monocomponents tiotropium 5 µg and olodaterol 5 µg all delivered by the Respimat® inhaler;Secondary Objective: Not applicable;Primary end point(s): 1: Trough FEV1 [L] after 28 days of treatment (measurement on Day 29) ;Timepoint(s) of evaluation of this end point: 1: Day 29	—

Measure

Time frame

Main Objective: The objective of this study is to show that the FDC of tiotropium + olodaterol (5/5 µg) is non inferior to the free combination of its monocomponents tiotropium 5 µg and olodaterol 5 µg all delivered by the Respimat® inhaler;Secondary Objective: Not applicable;Primary end point(s): 1: Trough FEV1 [L] after 28 days of treatment (measurement on Day 29) ;Timepoint(s) of evaluation of this end point: 1: Day 29

—

Secondary

Measure	Time frame
Secondary end point(s): 1: Trough FVC [L] after 28 days of treatment (measurement on Day 29) 2: COPD Assessment Test (CAT) score on Day 28 ;Timepoint(s) of evaluation of this end point: 1: Day 29 2: Day 28	—

Countries

Austria, Denmark, Finland, France, Slovenia

Contacts

Public ContactQRPE pSC CT Information Disclosure

Boehringer Ingelheim Pharma GmbH Co. & KG

clintriage.rdg@boehringer-ingelheim.com+18002430127

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026