Clinical trial NCT02683109: Fixed Dose Combination Versus Free Combination of Tiotropium and Olodaterol in COPD
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2016-02-17
Enrollment: 221
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Trough Forced Expiratory Volume in 1 Second (FEV1) (in Liter) After 28 Days of Treatment
timeFrame: Day 29
Secondary outcomes:
measure: Trough Forced Vital Capacity (FVC) (in Liter) After 28 Days of Treatment
timeFrame: Day 29
measure: Chronic Obstructive Pulmonary Disease (COPD) Assessment Test™ (CAT) Score on Day 28
timeFrame: Day 28
Other outcomes:
Locations:
city: Feldbach
country: Austria
facility: Ordination Dr. Robert Voves, 8330 Feldbach
city: Linz
country: Austria
facility: KH d. Elisabethinen Linz
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
city: Silkeborg
country: Denmark
facility: Regionshospitalet Silkeborg
city: Espoo
country: Finland
facility: Jorvin sairaala
city: Helsinki
country: Finland
facility: HYKS Keuhkosairauksien
city: Tampere
country: Finland
facility: TAYS, Keuhkotautien poliklinikka
city: Turku
country: Finland
facility: TYKS, Keuhkosairauksien klinikka, Turku
city: Turku
country: Finland
facility: Terveystalo Pulssi, Turku
city: Bron
country: France
facility: HOP Louis Pradel
city: Castelnau Le Lez
country: France
facility: CLI du Parc, Pneumo, Castelnau le Lez
city: Nice
country: France
facility: CAB Pigearias B., Pneumo, Nice
city: Nîmes
country: France
facility: CAB Dupouy J, Pneumo, Nîmes
city: Paris
country: France
facility: HOP Cochin
city: Pessac
country: France
facility: HOP Haut-Lévêque
city: Reims
country: France
facility: HOP Maison Blanche
city: Saint Laurent du Var
country: France
facility: INS A.Tzanck,Pneumo,St Laurent du Var
city: Vieux Condé
country: France
facility: CAB Lejay D, MG, Vieux Condé
city: Golnik
country: Slovenia
facility: Univ. Clinic of Respiratory and Allergic Diseases, Golnik
city: Litija
country: Slovenia
facility: Verboten Kopriva Renata - Private practice, Litija
city: Ljubljana
country: Slovenia
facility: Arjana Macek d.o.o.
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: