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Comparison of Two Bronchodilator Inhalers in Pediatric Asthmatics

NCT ID: NCT00112411

Last Updated: 2021-12-08

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

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2005-09-30

Brief Summary

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This study is designed to evaluate the single-dose effectiveness of two bronchodilator inhalers given at two dose levels in pediatric asthma patients.

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Bronchodilator

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Persistent asthma for a minimum of six months duration that has been stable for at least four weeks
* Predicted FEV1 60-90%
* Demonstration of 12% airway reversibility

Exclusion Criteria

* Continuous requirement for beta-blockers, monoamine oxidase (MAO) inhibitors, tricyclic antidepressants, anticholinergics and/or steroids other than those inhaled;
* Presence of clinically-significant non-asthmatic acute or chronic disease
Minimum Eligible Age

4 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Allergy Associates Medical Group, Inc.

San Diego, California, United States

Site Status

Aeroallergy Research Labs of Savannah, Inc.

Savannah, Georgia, United States

Site Status

University of Louisville

Louisville, Kentucky, United States

Site Status

Northeast Medical Research Associates, Inc.

North Dartmouth, Massachusetts, United States

Site Status

Mississippi Asthma and Allergy Clinic

Jackson, Mississippi, United States

Site Status

North Carolina Clinical Research

Raleigh, North Carolina, United States

Site Status

Allergy and Asthma Research Group

Eugene, Oregon, United States

Site Status

Allergy Associates Research Center

Portland, Oregon, United States

Site Status

Medical Research Network

The Woodlands, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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IXR-204-25-167

Identifier Type: -

Identifier Source: org_study_id