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

Pulmonary Disease, Chronic Obstructive Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02683109
• Other study ID #: 1237.49
• Secondary ID: 2015-003879-29
• Status: Completed
• Phase: Phase 4
• Start date: March 8, 2016
• Est. completion date: January 30, 2017

Study information

• Verified date: December 2017
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: January 30, 2017
• Est. primary completion date: January 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• FDC of tiotropium + olodaterol
Fixed Dose Combination of tiotropium + olodaterol
• Placebo

• Tiotropium

• Olodaterol

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Austria,  Denmark,  Finland,  France,  Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trough Forced Expiratory Volume in 1 Second (FEV1) (in Liter) After 28 Days of Treatment	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	Trough Forced Vital Capacity (FVC) (in Liter) After 28 Days of Treatment	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
Secondary	Chronic Obstructive Pulmonary Disease (COPD) Assessment Test™ (CAT) Score on 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

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