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Characterisation of 24-hour FEV1-time Profiles of Inhaled BI 1744 CL and Inhaled Foradil in Patients With Chronic Obstructive Pulmonary Disease

NCT ID: NCT00932646

Last Updated: 2016-02-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Brief Summary

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The study is intended to characterize the lung function profile of BI1744 in COPD patients where patients will perform pulmonary function tests at regular intervals for 24 hours at the end of a 6 week treatment period. Each patient will receive all four treatments.

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Single Dose Ranging Study of BI 1744 CL (Olodaterol) in Chronic Obstructive Pulmonary Disease

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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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BI1744 (Olodaterol)

Medium Dose once Daily

Group Type EXPERIMENTAL

BI 1744 (Olodaterol) Medium Dose

Intervention Type DRUG

BI1744 Respimat medium dose once daily and placebo Foradil

BI 1744 (Olodaterol)

Low Dose once Daily

Group Type EXPERIMENTAL

BI 1744 (Olodaterol) Low Dose

Intervention Type DRUG

BI1744 Respimat low dose once daily and placebo Foradil

Placebo

Placebo once Daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo Respimat once daily and placebo Foradil

Foradil

12 mcg twice daily

Group Type ACTIVE_COMPARATOR

Foradil

Intervention Type DRUG

12 mcg twice daily and placebo Respimat

Interventions

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BI 1744 (Olodaterol) Low Dose

BI1744 Respimat low dose once daily and placebo Foradil

Intervention Type DRUG

BI 1744 (Olodaterol) Medium Dose

BI1744 Respimat medium dose once daily and placebo Foradil

Intervention Type DRUG

Placebo

Placebo Respimat once daily and placebo Foradil

Intervention Type DRUG

Foradil

12 mcg twice daily and placebo Respimat

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients willing to participate with confirmed diagnosis of COPD
* 40 years of age or older
* having a 10 pack year smoking history
* able to perform serial pulmonary function tests
* able to use both a DPI and Respimat device

Exclusion Criteria

Significant other disease

* clinically relevant abnormal hematology, chemistry, or urinalysis
* history of asthma
* diagnosis of thyrotoxicosis
* paroxysmal tachycardia related to beta agonists
* history of MI within 1 year, cardiac arrhythmia, hospitalization for heart failure within 1 year
* active tuberculosis, cystic fibrosis, clinically evident bronchiectasis
* significant alcohol or drug use
* pulmonary resection
* taking oral beta adrenergics
* taking unstable oral steroids
* daytime oxygen
* enrolled in rehabilitation program
* enrolled in another study or taking investigational products
* pregnant or nursing women, women of child bearing potential not willing to use two methods of birth control
* those who are not willing to comply with pulmonary medication washouts
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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1222.25.25009 Boehringer Ingelheim Investigational Site

Jasper, Alabama, United States

Site Status

1222.25.25002 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

Site Status

1222.25.25003 Boehringer Ingelheim Investigational Site

DeLand, Florida, United States

Site Status

1222.25.25007 Boehringer Ingelheim Investigational Site

Winter Park, Florida, United States

Site Status

1222.25.25010 Boehringer Ingelheim Investigational Site

Austell, Georgia, United States

Site Status

1222.25.25008 Boehringer Ingelheim Investigational Site

Albuquerque, New Mexico, United States

Site Status

1222.25.25012 Boehringer Ingelheim Investigational Site

Charlotte, North Carolina, United States

Site Status

1222.25.25004 Boehringer Ingelheim Investigational Site

Raleigh, North Carolina, United States

Site Status

1222.25.25011 Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

Site Status

1222.25.25014 Boehringer Ingelheim Investigational Site

Seneca, South Carolina, United States

Site Status

1222.25.25006 Boehringer Ingelheim Investigational Site

Knoxville, Tennessee, United States

Site Status

1222.25.25005 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Site Status

1222.25.25013 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Site Status

Countries

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United States

References

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Feldman GJ, Bernstein JA, Hamilton A, Nivens MC, Korducki L, LaForce C. The 24-h FEV1 time profile of olodaterol once daily via Respimat(R) and formoterol twice daily via Aerolizer(R) in patients with GOLD 2-4 COPD: results from two 6-week crossover studies. Springerplus. 2014 Aug 9;3:419. doi: 10.1186/2193-1801-3-419. eCollection 2014.

Reference Type DERIVED
PMID: 25187881 (View on PubMed)

Other Identifiers

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1222.25

Identifier Type: -

Identifier Source: org_study_id

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