A Crossover Study in the Treatment of Patients With COPD

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2007-10-31

Brief Summary

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The purpose of this study is to compare the efficacy of Formoterol Fumarate Inhalation Solution (FFIS) 20 mcg BID to Combivent® Inhalation Aerosol \[2 inhalations from metered dose inhaler (MDI)of 18 mcg ipratropium bromide and 103 mcg albuterol sulfate QID\], and to Compare the preference/compliance of BID nebulization to QID use of MDI

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Formoterol Fumurate inhalation solution 20 mcg

Intervention Type DRUG

Ipratropium bromide 18 mcg and albuterol sulfate 103 mcg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of COPD
* Smoker or exsmoker with at least 10 years smoking at least one pack of cigarettes per day
* Meet lung function requirements

Exclusion Criteria

* Diagnosis of Asthma
* Significant disease other than COPD
* Female pregnant or lactating or planning to become pregnant

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Dey

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United States

References

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Sutherland ER, Brazinsky S, Feldman G, McGinty J, Tomlinson L, Denis-Mize K. Nebulized formoterol effect on bronchodilation and satisfaction in COPD patients compared to QID ipratropium/albuterol MDI. Curr Med Res Opin. 2009 Mar;25(3):653-61. doi: 10.1185/03007990802708152.

Reference Type RESULT

PMID: 19232039 (View on PubMed)

Other Identifiers

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201-081

Identifier Type: -

Identifier Source: org_study_id

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Study Results

Basic Information

Brief Summary

Related Clinical Trials

Efficacy Safety Study of Arformoterol QD Dosing Versus BID Dosing in COPD

Study in Subjects Greater Than 40 Years of Age With COPD

A Study Evaluating Systemic Exposure and Pharmacodynamics in Patients With Chronic Obstructive Pulmonary Disease

A Trial to Evaluate the Efficacy and Safety of Formoterol Fumarate 20 Mcg/0.5 mL in the Treatment of Patients With COPD

Assessment of Switching From Salmeterol/Fluticasone to Indacaterol/Glycopyrronium in a symtomaticCOPD Patient Cohort

Detailed Description

Conditions

Study Design

Interventions

Formoterol Fumurate inhalation solution 20 mcg

Ipratropium bromide 18 mcg and albuterol sulfate 103 mcg

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Dey

Responsible Party

Locations

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Countries

References

Sutherland ER, Brazinsky S, Feldman G, McGinty J, Tomlinson L, Denis-Mize K. Nebulized formoterol effect on bronchodilation and satisfaction in COPD patients compared to QID ipratropium/albuterol MDI. Curr Med Res Opin. 2009 Mar;25(3):653-61. doi: 10.1185/03007990802708152.

Other Identifiers

201-081

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