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

Phase 4

Completed

Interventions: Drug: FDC of tiotropium + olodaterol
Drug: Tiotropium
Drug: Placebo
Drug: Olodaterol

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
FDC of tiotropium + olodaterol	FDC of tiotropium + olodaterol	Fixed Dose Combination of tiotropium + olodaterol
FDC of tiotropium + olodaterol	Placebo	Fixed Dose Combination of tiotropium + olodaterol
Free combination tiotropium + olodaterol	Tiotropium	-
Free combination tiotropium + olodaterol	Olodaterol	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Trough Forced Vital Capacity (FVC) (in Liter) After 28 Days of Treatment	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	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.

Locations (22): Ordination Dr. Robert Voves, 8330 Feldbach
🇦🇹
Feldbach, Austria
KH d. Elisabethinen Linz
🇦🇹
Linz, Austria
Aarhus Universitetshospital
🇩🇰
Aarhus, Denmark
TAYS, Keuhkotautien poliklinikka
🇫🇮
Tampere, Finland
Terveystalo Pulssi, Turku
🇫🇮
Turku, Finland
HOP Maison Blanche
🇫🇷
Reims, France
CAB Pigearias B., Pneumo, Nice
🇫🇷
Nice, France
HOP Cochin
🇫🇷
Paris, France
TYKS, Keuhkosairauksien klinikka, Turku
🇫🇮
Turku, Finland
HYKS Keuhkosairauksien
🇫🇮
Helsinki, Finland
Jorvin sairaala
🇫🇮
Espoo, Finland
Hvidovre Hospital
🇩🇰
Hvidovre, Denmark
Regionshospitalet Silkeborg
🇩🇰
Silkeborg, Denmark
CLI du Parc, Pneumo, Castelnau le Lez
🇫🇷
Castelnau Le Lez, France
HOP Louis Pradel
🇫🇷
Bron, France
CAB Dupouy J, Pneumo, Nîmes
🇫🇷
Nîmes, France
HOP Haut-Lévêque
🇫🇷
Pessac, France
INS A.Tzanck,Pneumo,St Laurent du Var
🇫🇷
Saint Laurent du Var, France
CAB Lejay D, MG, Vieux Condé
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Vieux Condé, France
Univ. Clinic of Respiratory and Allergic Diseases, Golnik
🇸🇮
Golnik, Slovenia
Verboten Kopriva Renata - Private practice, Litija
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Litija, Slovenia
Arjana Macek d.o.o.
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Ljubljana, Slovenia