- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00112411
Comparison of Two Bronchodilator Inhalers in Pediatric Asthmatics
December 1, 2021 updated by: Teva Branded Pharmaceutical Products R&D, Inc.
Dose-ranging Double-blind, Placebo-controlled Efficacy Comparison of Two Bronchodilator Inhalers in Pediatric Asthmatics
This study is designed to evaluate the single-dose effectiveness of two bronchodilator inhalers given at two dose levels in pediatric asthma patients.
Study Overview
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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San Diego, California, United States, 92120
- Allergy Associates Medical Group, Inc.
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Georgia
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Savannah, Georgia, United States, 31409
- Aeroallergy Research Labs of Savannah, Inc.
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Kentucky
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Louisville, Kentucky, United States, 40202
- University of Louisville
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Massachusetts
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North Dartmouth, Massachusetts, United States, 02747
- Northeast Medical Research Associates, Inc.
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Mississippi
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Jackson, Mississippi, United States, 39202
- Mississippi Asthma and Allergy Clinic
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North Carolina
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Raleigh, North Carolina, United States, 27607
- North Carolina Clinical Research
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Oregon
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Eugene, Oregon, United States, 97401
- Allergy and Asthma Research Group
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Portland, Oregon, United States, 97213
- Allergy Associates Research Center
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Texas
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The Woodlands, Texas, United States, 77380
- Medical Research Network
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 11 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 30, 2005
Primary Completion (Actual)
September 30, 2005
Study Completion (Actual)
September 30, 2005
Study Registration Dates
First Submitted
June 2, 2005
First Submitted That Met QC Criteria
June 2, 2005
First Posted (Estimate)
June 3, 2005
Study Record Updates
Last Update Posted (Actual)
December 8, 2021
Last Update Submitted That Met QC Criteria
December 1, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Bronchodilator Agents
Other Study ID Numbers
- IXR-204-25-167
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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