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Study in Subjects Greater Than 40 Years of Age With COPD

NCT ID: NCT00507234

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

PHASE3

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-04-30

Brief Summary

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This is a multicenter, Phase IIIb, randomized, double-blind, active-controlled, parallel-group, comparative study.

The objectives of this study are:

1. To compare the efficacy of tiotropium 18 mcg once daily plus Formoterol Fumarate Inhalation Solution (FFIS) 20 mcg twice daily to tiotropium 18 mcg once daily.
2. To obtain safety data on the use of tiotropium 18 mcg once daily plus FFIS 20 mcg twice daily compared to tiotropium 18 mcg once daily.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Keywords

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COPD

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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formoterol fumarate inhalation solution

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

Principal Investigators

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Nicola A Hanania, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

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Clinical Research Site

Mobile, Alabama, United States

Site Status

Clinical Research Site

Phoenix, Arizona, United States

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Clinical Research Site

DeLand, Florida, United States

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Clinical Research Site

Atlanta, Georgia, United States

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Clinical Research Site

Livonia, Michigan, United States

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Clinical Research Site

Saint Charles, Missouri, United States

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Clinical Research Site

St Louis, Missouri, United States

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Clinical Research Site

Albany, New York, United States

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Clinical Research Site

North Syracuse, New York, United States

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Clinical Research Site

Williamsville, New York, United States

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Clinical Research Site

Toledo, Ohio, United States

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Clinical Research Site

Medford, Oregon, United States

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Clinical Research Site

Portland, Oregon, United States

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Clinical Research Site

Greenville, South Carolina, United States

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Clinical Research Site

Spartanburg, South Carolina, United States

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Clinical Research Site

San Antonio, Texas, United States

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Clinical Research Site

Abingdon, Virginia, United States

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Clinical Research Site

Richmond, Virginia, United States

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Clinical Research Site

Milwaukee, Wisconsin, United States

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Countries

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United States

References

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Hanania NA, Boota A, Kerwin E, Tomlinson L, Denis-Mize K. Efficacy and safety of nebulized formoterol as add-on therapy in COPD patients receiving maintenance tiotropium bromide: Results from a 6-week, randomized, placebo-controlled, clinical trial. Drugs. 2009 Jun 18;69(9):1205-16. doi: 10.2165/00003495-200969090-00005.

Reference Type RESULT
PMID: 19537837 (View on PubMed)

Other Identifiers

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201-080

Identifier Type: -

Identifier Source: org_study_id