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Comparison of Two Bronchodilator Inhalers in Pediatric Asthmatics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier:
NCT00112411
First received: June 2, 2005
Last updated: July 3, 2012
Last verified: December 2005
History of Changes
  Purpose

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


Condition Intervention Phase
Asthma
 Drug: Bronchodilator
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Dose-ranging Double-blind, Placebo-controlled Efficacy Comparison of Two Bronchodilator Inhalers in Pediatric Asthmatics

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by Teva Pharmaceutical Industries:

Study Start Date: June 2005
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   4 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00112411

Locations
United States, California
Allergy Associates Medical Group, Inc.
San Diego, California, United States, 92120
United States, Georgia
Aeroallergy Research Labs of Savannah, Inc.
Savannah, Georgia, United States, 31409
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Northeast Medical Research Associates, Inc.
North Dartmouth, Massachusetts, United States, 02747
United States, Mississippi
Mississippi Asthma and Allergy Clinic
Jackson, Mississippi, United States, 39202
United States, North Carolina
North Carolina Clinical Research
Raleigh, North Carolina, United States, 27607
United States, Oregon
Allergy and Asthma Research Group
Eugene, Oregon, United States, 97401
Allergy Associates Research Center
Portland, Oregon, United States, 97213
United States, Texas
Medical Research Network
The Woodlands, Texas, United States, 77380
Sponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier: NCT00112411     History of Changes
Other Study ID Numbers: IXR-204-25-167
Study First Received: June 2, 2005
Last Updated: July 3, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
 Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013