Fixed Dose Combination Versus Free Combination of Tiotropium and Olodaterol in COPD
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|ClinicalTrials.gov Identifier: NCT02683109|
Recruitment Status : Completed
First Posted : February 17, 2016
Results First Posted : August 17, 2018
Last Update Posted : August 17, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Disease, Chronic Obstructive||Drug: FDC of tiotropium + olodaterol Drug: Placebo Drug: Tiotropium Drug: Olodaterol||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||221 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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)|
|Actual Study Start Date :||March 8, 2016|
|Actual Primary Completion Date :||January 9, 2017|
|Actual Study Completion Date :||January 30, 2017|
Experimental: FDC of tiotropium + olodaterol
Fixed Dose Combination of tiotropium + olodaterol
Drug: FDC of tiotropium + olodaterol
Fixed Dose Combination of tiotropium + olodaterol
|Active Comparator: Free combination tiotropium + olodaterol||
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02683109
|Ordination Dr. Robert Voves, 8330 Feldbach|
|Feldbach, Austria, 8330|
|KH d. Elisabethinen Linz|
|Linz, Austria, 4020|
|Aarhus, Denmark, 8000|
|Hvidovre, Denmark, 2650|
|Silkeborg, Denmark, 8600|
|Espoo, Finland, FI-02740|
|Helsinki, Finland, 00029|
|TAYS, Keuhkotautien poliklinikka|
|Tampere, Finland, FI-33520|
|TYKS, Keuhkosairauksien klinikka, Turku|
|Turku, Finland, 20520|
|Terveystalo Pulssi, Turku|
|Turku, Finland, FI-20100|
|HOP Louis Pradel|
|Bron, France, 69677|
|CLI du Parc, Pneumo, Castelnau le Lez|
|Castelnau Le Lez, France, 34170|
|CAB Pigearias B., Pneumo, Nice|
|Nice, France, 06000|
|CAB Dupouy J, Pneumo, Nîmes|
|Nîmes, France, 30900|
|Paris, France, 75014|
|Pessac, France, 33604|
|HOP Maison Blanche|
|Reims, France, 51092|
|INS A.Tzanck,Pneumo,St Laurent du Var|
|Saint Laurent du Var, France, 06721|
|CAB Lejay D, MG, Vieux Condé|
|Vieux Condé, France, 59690|
|Univ. Clinic of Respiratory and Allergic Diseases, Golnik|
|Golnik, Slovenia, 4204|
|Verboten Kopriva Renata - Private practice, Litija|
|Litija, Slovenia, 1270|
|Arjana Macek d.o.o.|
|Ljubljana, Slovenia, 1000|
|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|