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

December 7, 2017 updated by: Boehringer Ingelheim

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)

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 Overview

Study Type

Interventional

Enrollment (Actual)

221

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Feldbach, Austria, 8330
        • Ordination Dr. Robert Voves, 8330 Feldbach
      • Linz, Austria, 4020
        • KH d. Elisabethinen Linz
      • Aarhus, Denmark, 8000
        • Aarhus Universitetshospital
      • Hvidovre, Denmark, 2650
        • Hvidovre Hospital
      • Silkeborg, Denmark, 8600
        • Regionshospitalet Silkeborg
      • Espoo, Finland, FI-02740
        • Jorvin sairaala
      • Helsinki, Finland, 00029
        • HYKS Keuhkosairauksien
      • Tampere, Finland, FI-33520
        • TAYS, Keuhkotautien poliklinikka
      • Turku, Finland, 20520
        • TYKS, Keuhkosairauksien klinikka, Turku
      • Turku, Finland, FI-20100
        • Terveystalo Pulssi, Turku
      • Bron, France, 69677
        • HOP Louis Pradel
      • Castelnau Le Lez, France, 34170
        • CLI du Parc, Pneumo, Castelnau le Lez
      • Nice, France, 06000
        • CAB Pigearias B., Pneumo, Nice
      • Nîmes, France, 30900
        • CAB Dupouy J, Pneumo, Nîmes
      • Paris, France, 75014
        • HOP Cochin
      • Pessac, France, 33604
        • HOP Haut-Lévêque
      • Reims, France, 51092
        • HOP Maison Blanche
      • Saint Laurent du Var, France, 06721
        • INS A.Tzanck,Pneumo,St Laurent du Var
      • Vieux Condé, France, 59690
        • CAB Lejay D, MG, Vieux Condé
      • Golnik, Slovenia, 4204
        • Univ. Clinic of Respiratory and Allergic Diseases, Golnik
      • Litija, Slovenia, 1270
        • Verboten Kopriva Renata - Private practice, Litija
      • Ljubljana, Slovenia, 1000
        • Arjana Macek d.o.o.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FDC of tiotropium + olodaterol
Fixed Dose Combination of tiotropium + olodaterol
Fixed Dose Combination of tiotropium + olodaterol
Active Comparator: Free combination tiotropium + olodaterol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trough Forced Expiratory Volume in 1 Second (FEV1) (in Liter) After 28 Days of Treatment
Time Frame: Day 29

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.

Day 29

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trough Forced Vital Capacity (FVC) (in Liter) After 28 Days of Treatment
Time Frame: Day 29

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.

Day 29
Chronic Obstructive Pulmonary Disease (COPD) Assessment Test™ (CAT) Score on Day 28
Time Frame: 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.

Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2016

Primary Completion (Actual)

January 9, 2017

Study Completion (Actual)

January 30, 2017

Study Registration Dates

First Submitted

February 12, 2016

First Submitted That Met QC Criteria

February 12, 2016

First Posted (Estimate)

February 17, 2016

Study Record Updates

Last Update Posted (Actual)

August 17, 2018

Last Update Submitted That Met QC Criteria

December 7, 2017

Last Verified

December 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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