- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02683109
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)
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Feldbach, Austria, 8330
- Ordination Dr. Robert Voves, 8330 Feldbach
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Linz, Austria, 4020
- KH d. Elisabethinen Linz
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Aarhus, Denmark, 8000
- Aarhus Universitetshospital
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Hvidovre, Denmark, 2650
- Hvidovre Hospital
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Silkeborg, Denmark, 8600
- Regionshospitalet Silkeborg
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Espoo, Finland, FI-02740
- Jorvin sairaala
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Helsinki, Finland, 00029
- HYKS Keuhkosairauksien
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Tampere, Finland, FI-33520
- TAYS, Keuhkotautien poliklinikka
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Turku, Finland, 20520
- TYKS, Keuhkosairauksien klinikka, Turku
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Turku, Finland, FI-20100
- Terveystalo Pulssi, Turku
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Bron, France, 69677
- HOP Louis Pradel
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Castelnau Le Lez, France, 34170
- CLI du Parc, Pneumo, Castelnau le Lez
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Nice, France, 06000
- CAB Pigearias B., Pneumo, Nice
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Nîmes, France, 30900
- CAB Dupouy J, Pneumo, Nîmes
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Paris, France, 75014
- HOP Cochin
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Pessac, France, 33604
- HOP Haut-Lévêque
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Reims, France, 51092
- HOP Maison Blanche
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Saint Laurent du Var, France, 06721
- INS A.Tzanck,Pneumo,St Laurent du Var
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Vieux Condé, France, 59690
- CAB Lejay D, MG, Vieux Condé
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Golnik, Slovenia, 4204
- Univ. Clinic of Respiratory and Allergic Diseases, Golnik
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Litija, Slovenia, 1270
- Verboten Kopriva Renata - Private practice, Litija
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Ljubljana, Slovenia, 1000
- Arjana Macek d.o.o.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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Active Comparator: Free combination tiotropium + olodaterol
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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
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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
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Chronic Obstructive Pulmonary Disease (COPD) Assessment Test™ (CAT) Score on Day 28
Time Frame: Day 28
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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
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Lung Diseases, Obstructive
- Lung Diseases
- Pulmonary Disease, Chronic Obstructive
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Antagonists
- Cholinergic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Tiotropium Bromide
- Olodaterol
Other Study ID Numbers
- 1237.49
- 2015-003879-29 (EudraCT Number)
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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