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Determining Optimal Free Dose Combination of Tiotropium Bromide and BI 1744 CL in Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT01040403

Last Updated: 2015-07-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

233 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Brief Summary

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The primary objective of this study is to determine the optimum once daily dose of BI 1744 CL and tiotropium in free dose combination (delivered by the Respimat inhaler) after four week treatment 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

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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olodaterol (BI 1744) low and placebo

low dose inhaled olodaterol orally once daily from the Respimat inhaler

Group Type EXPERIMENTAL

olodaterol (BI 1744) low

Intervention Type DRUG

olodaterol (BI 1744) low

Placebo

Intervention Type DRUG

Placebo

Respimat

Intervention Type DEVICE

Respimat inhaler

olodaterol (BI 1744) low and low tio

low dose inhaled olodaterol and low dose inhaled tiotropium, both from the Respimat inhaler and once daily

Group Type EXPERIMENTAL

olodaterol (BI 1744) low

Intervention Type DRUG

olodaterol (BI 1744) low

low tiotropium bromide

Intervention Type DRUG

low tiotropium bromide

Respimat

Intervention Type DEVICE

Respimat inhaler

olodaterol (BI 1744) low and medium tio

low dose inhaled olodaterol and medium dose inhaled tiotropium, both from the Respimat inhaler and once daily

Group Type EXPERIMENTAL

olodaterol (BI 1744) low

Intervention Type DRUG

olodaterol (BI 1744) low

medium tiotropium bromide

Intervention Type DRUG

medium tiotropium bromide

Respimat

Intervention Type DEVICE

Respimat inhaler

olodaterol (BI 1744) low and high tio

low dose inhaled olodaterol and high dose inhaled tiotropium, both from the Respimat inhaler and once daily

Group Type EXPERIMENTAL

olodaterol (BI 1744) low

Intervention Type DRUG

olodaterol (BI 1744) low

high tiotropium bromide

Intervention Type DRUG

high tiotropium bromide

Respimat

Intervention Type DEVICE

Respimat inhaler

olodaterol (BI 1744) high and placebo

high dose inhaled olodaterol orally once daily from the Respimat inhaler

Group Type EXPERIMENTAL

olodaterol (BI 1744) high

Intervention Type DRUG

olodaterol (BI 1744) high

Placebo

Intervention Type DRUG

Placebo

Respimat

Intervention Type DEVICE

Respimat inhaler

Olodaterol (BI 1744) high and low tio

high dose inhaled olodaterol and low dose inhaled tiotropium, both from the Respimat inhaler and once daily

Group Type EXPERIMENTAL

low tiotropium bromide

Intervention Type DRUG

low tiotropium bromide

olodaterol (BI 1744) high

Intervention Type DRUG

olodaterol (BI 1744) high

Respimat

Intervention Type DEVICE

Respimat inhaler

Olodaterol (BI 1744) high and medium tio

high dose inhaled olodaterol and medium dose inhaled tiotropium, both from the Respimat inhaler and once daily

Group Type EXPERIMENTAL

olodaterol (BI 1744) high

Intervention Type DRUG

olodaterol (BI 1744) high

medium tiotropium bromide

Intervention Type DRUG

medium tiotropium bromide

Respimat

Intervention Type DEVICE

Respimat inhaler

Olodaterol (BI 1744) high and high tio

high dose inhaled olodaterol and high dose inhaled tiotropium, both from the Respimat inhaler and once daily

Group Type EXPERIMENTAL

olodaterol (BI 1744) high

Intervention Type DRUG

olodaterol (BI 1744) high

high tiotropium bromide

Intervention Type DRUG

high tiotropium bromide

Respimat

Intervention Type DEVICE

Respimat inhaler

Interventions

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olodaterol (BI 1744) low

olodaterol (BI 1744) low

Intervention Type DRUG

low tiotropium bromide

low tiotropium bromide

Intervention Type DRUG

olodaterol (BI 1744) high

olodaterol (BI 1744) high

Intervention Type DRUG

medium tiotropium bromide

medium tiotropium bromide

Intervention Type DRUG

high tiotropium bromide

high tiotropium bromide

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Respimat

Respimat inhaler

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. All patients must sign an informed consent
2. All patients must have a diagnosis of chronic obstructive pulmonary disease (COPD) must meet the following spirometric criteria:

a post-bronchodilator forced expiratory flow in 1 second (FEV1) =\<30% of predicted normal and \<80% of predicted normal and a post bronchodilator FEV1 / forced vital capacity (FVC) \<70% at Visit 1 4. Male or female patients, 40 years of age or older. 5. Patients must be current or ex-smokers with a smoking history of more than 10 pack years

Exclusion Criteria

* Patients with a significant disease other than COPD;
* Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis;
* Patients with a history of asthma or a total blood eosinophil count \>=600/mm3.
* Patients with any of the following conditions:

a diagnosis of thyrotoxicosis (due to the known class side effect profile of ß2-agonists) a diagnosis of paroxysmal tachycardia - Patients with any of the following conditions: a history of myocardial infarction within 1 year of screening visit a diagnosis of clinically relevant cardiac arrhythmia a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years

* Patients who have undergone thoracotomy with pulmonary resection
* Patients being treated with the following concomitant medications:

medications that prolong the QT/QTc interval oral Beta-adrenergics oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day

\- Pregnant or nursing women
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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Boehringer Ingelheim

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1237.18.02004 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Site Status

1237.18.02005 Boehringer Ingelheim Investigational Site

Grimsby, Ontario, Canada

Site Status

1237.18.02001 Boehringer Ingelheim Investigational Site

Mississauga, Ontario, Canada

Site Status

1237.18.02008 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Site Status

1237.18.02002 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Site Status

1237.18.02003 Boehringer Ingelheim Investigational Site

Point Claire, Quebec, Canada

Site Status

1237.18.02009 Boehringer Ingelheim Investigational Site

Québec, Quebec, Canada

Site Status

1237.18.02007 Boehringer Ingelheim Investigational Site

Sherbrooke, Quebec, Canada

Site Status

1237.18.02011 Boehringer Ingelheim Investigational Site

Saskatoon, Saskatchewan, Canada

Site Status

1237.18.49009 Boehringer Ingelheim Investigational Site

Aschaffenburg, , Germany

Site Status

1237.18.49012 Boehringer Ingelheim Investigational Site

Bamberg, , Germany

Site Status

1237.18.49005 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1237.18.49004 Boehringer Ingelheim Investigational Site

Frankfurt, , Germany

Site Status

1237.18.49011 Boehringer Ingelheim Investigational Site

Hamburg, , Germany

Site Status

1237.18.49010 Boehringer Ingelheim Investigational Site

Koblenz, , Germany

Site Status

1237.18.49007 Boehringer Ingelheim Investigational Site

Mannheim, , Germany

Site Status

1237.18.49001 Boehringer Ingelheim Investigational Site

Potsdam, , Germany

Site Status

1237.18.49006 Boehringer Ingelheim Investigational Site

Rodgau-Dudenhofen, , Germany

Site Status

1237.18.49002 Boehringer Ingelheim Investigational Site

Rüdersdorf, , Germany

Site Status

1237.18.49003 Boehringer Ingelheim Investigational Site

Weinheim, , Germany

Site Status

1237.18.49008 Boehringer Ingelheim Investigational Site

Wiesloch, , Germany

Site Status

1237.18.31004 Boehringer Ingelheim Investigational Site

Almelo, , Netherlands

Site Status

1237.18.31006 Boehringer Ingelheim Investigational Site

Amsterdam, , Netherlands

Site Status

1237.18.31008 Boehringer Ingelheim Investigational Site

Eindhoven, , Netherlands

Site Status

1237.18.31001 Boehringer Ingelheim Investigational Site

Groningen, , Netherlands

Site Status

1237.18.31007 Boehringer Ingelheim Investigational Site

Hengelo, , Netherlands

Site Status

1237.18.31005 Boehringer Ingelheim Investigational Site

Hoorn, , Netherlands

Site Status

1237.18.31002 Boehringer Ingelheim Investigational Site

Veldhoven, , Netherlands

Site Status

1237.18.31003 Boehringer Ingelheim Investigational Site

Zutphen, , Netherlands

Site Status

1237.18.46003 Boehringer Ingelheim Investigational Site

Boden, , Sweden

Site Status

1237.18.46002 Boehringer Ingelheim Investigational Site

Gothenburg, , Sweden

Site Status

1237.18.46001 Boehringer Ingelheim Investigational Site

Lund, , Sweden

Site Status

1237.18.46004 Boehringer Ingelheim Investigational Site

Stockholm, , Sweden

Site Status

Countries

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Canada Germany Netherlands Sweden

References

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Aalbers R, Maleki-Yazdi MR, Hamilton A, Waitere-Wijker S, Zhao Y, Amatto VC, Schmidt O, Bjermer L. Randomized, Double-Blind, Dose-Finding Study for Tiotropium when Added to Olodaterol, Administered via the Respimat(R) Inhaler in Patients with Chronic Obstructive Pulmonary Disease. Adv Ther. 2015 Sep;32(9):809-22. doi: 10.1007/s12325-015-0239-8. Epub 2015 Sep 24.

Reference Type DERIVED
PMID: 26404912 (View on PubMed)

Other Identifiers

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2009-014880-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1237.18

Identifier Type: -

Identifier Source: org_study_id

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