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

NCT ID: NCT02683109

Last Updated: 2018-08-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

221 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-08

Study Completion Date

2017-01-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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FDC of tiotropium + olodaterol

Fixed Dose Combination of tiotropium + olodaterol

Group Type EXPERIMENTAL

FDC of tiotropium + olodaterol

Intervention Type DRUG

Fixed Dose Combination of tiotropium + olodaterol

Placebo

Intervention Type DRUG

Free combination tiotropium + olodaterol

Group Type ACTIVE_COMPARATOR

Tiotropium

Intervention Type DRUG

Olodaterol

Intervention Type DRUG

Interventions

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FDC of tiotropium + olodaterol

Fixed Dose Combination of tiotropium + olodaterol

Intervention Type DRUG

Placebo

Intervention Type DRUG

Tiotropium

Intervention Type DRUG

Olodaterol

Intervention Type DRUG

Eligibility Criteria

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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.

Exclusion Criteria

* COPD exacerbation or symptoms of lower respiratory tract infection within 6 weeks prior to screening.
* Patients with a current diagnosis of asthma.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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Ordination Dr. Robert Voves, 8330 Feldbach

Feldbach, , Austria

Site Status

KH d. Elisabethinen Linz

Linz, , Austria

Site Status

Aarhus Universitetshospital

Aarhus, , Denmark

Site Status

Hvidovre Hospital

Hvidovre, , Denmark

Site Status

Regionshospitalet Silkeborg

Silkeborg, , Denmark

Site Status

Jorvin sairaala

Espoo, , Finland

Site Status

HYKS Keuhkosairauksien

Helsinki, , Finland

Site Status

TAYS, Keuhkotautien poliklinikka

Tampere, , Finland

Site Status

TYKS, Keuhkosairauksien klinikka, Turku

Turku, , Finland

Site Status

Terveystalo Pulssi, Turku

Turku, , Finland

Site Status

HOP Louis Pradel

Bron, , France

Site Status

CLI du Parc, Pneumo, Castelnau le Lez

Castelnau-le-Lez, , France

Site Status

CAB Pigearias B., Pneumo, Nice

Nice, , France

Site Status

CAB Dupouy J, Pneumo, Nîmes

Nîmes, , France

Site Status

HOP Cochin

Paris, , France

Site Status

HOP Haut-Lévêque

Pessac, , France

Site Status

HOP Maison Blanche

Reims, , France

Site Status

INS A.Tzanck,Pneumo,St Laurent du Var

Saint-Laurent-du-Var, , France

Site Status

CAB Lejay D, MG, Vieux Condé

Vieux-Condé, , France

Site Status

Univ. Clinic of Respiratory and Allergic Diseases, Golnik

Golnik, , Slovenia

Site Status

Verboten Kopriva Renata - Private practice, Litija

Litija, , Slovenia

Site Status

Arjana Macek d.o.o.

Ljubljana, , Slovenia

Site Status

Countries

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Austria Denmark Finland France Slovenia

Other Identifiers

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2015-003879-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1237.49

Identifier Type: -

Identifier Source: org_study_id

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