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Study in Patients With COPD

NCT ID: NCT00215423

Last Updated: 2010-11-11

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

PHASE2

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2005-09-30

Brief Summary

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The purpose of this study is to determine which dose of the investigational drug is the most safe and effective for the treatment of COPD compared to the control drug

Detailed Description

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Conditions

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COPD Chronic Obstructive Pulmonary Disease

Keywords

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COPD Chronic Obstructive Pulmonary Disease Formoterol Fumarate Formoterol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Formoterol Fumarate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of COPD
* History of cigarette smoking

Exclusion Criteria

* Clinical diagnosis of asthma
* Significant pulmonary disease other than COPD
* Other significant major organ disease(s)
Minimum Eligible Age

5 Years

Maximum Eligible Age

70 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

Locations

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Research Site

Phoenix, Arizona, United States

Site Status

Research Site

Wheat Ridge, Colorado, United States

Site Status

Research Site

Hines, Illinois, United States

Site Status

Research Site

Shawnee Mission, Kansas, United States

Site Status

Research Site

Butte, Montana, United States

Site Status

Research Site

Omaha, Nebraska, United States

Site Status

Research Site

Medford, Oregon, United States

Site Status

Countries

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United States

References

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Gross NJ, Kerwin E, Levine B, Kim KT, Denis-Mize K, Hamzavi M, Carpenter M, Rinehart M. Nebulized formoterol fumarate: Dose selection and pharmacokinetics. Pulm Pharmacol Ther. 2008 Oct;21(5):818-23. doi: 10.1016/j.pupt.2008.07.002. Epub 2008 Jul 8.

Reference Type RESULT
PMID: 18655841 (View on PubMed)

Other Identifiers

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DL-057

Identifier Type: -

Identifier Source: org_study_id