A Phase IIIB Study to Compare the Efficacy and Safety of Concomitant Treatment in Patients With COPD

NCT ID: NCT00308191

Last Updated: 2008-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2006-12-31

Brief Summary

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The purpose of this study is to evaluate the safety and efficacy of the concomitant treatment of formoterol fumarate with tiotropium bromide compared to treatment with tiotropium bromide alone.

Detailed Description

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Conditions

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Formoterol Fumarate

Intervention Type DRUG

Tiotropium Bromide

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Medical diagnosis of COPD
* Current or prior history of cigarette smoking

Exclusion Criteria

* Medical diagnosis of asthma
* Significant condition or disease other than COPD
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dey

INDUSTRY

Sponsor Role lead

Responsible Party

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Dey L.P.

Locations

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Research Site

Phoenix, Arizona, United States

Site Status

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Los Angeles, California, United States

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Sepulveda, California, United States

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Walnut Creek, California, United States

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Colorado Springs, Colorado, United States

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Tamarac, Florida, United States

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Gainesville, Georgia, United States

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Auburn, Maine, United States

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Ann Arbor, Michigan, United States

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Livonia, Michigan, United States

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St Louis, Missouri, United States

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Liverpool, New York, United States

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Rochester, New York, United States

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Medford, Oregon, United States

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Collegeville, Pennsylvania, United States

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El Paso, Texas, United States

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San Antonio, Texas, United States

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Countries

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United States

References

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Tashkin DP, Littner M, Andrews CP, Tomlinson L, Rinehart M, Denis-Mize K. Concomitant treatment with nebulized formoterol and tiotropium in subjects with COPD: a placebo-controlled trial. Respir Med. 2008 Apr;102(4):479-87. doi: 10.1016/j.rmed.2007.12.019. Epub 2008 Feb 6.

Reference Type RESULT
PMID: 18258423 (View on PubMed)

Other Identifiers

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201-070

Identifier Type: -

Identifier Source: org_study_id

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