Chronic-Dose Safety and Efficacy Study of a Bronchodilator Inhaler in Pediatric Asthmatics

This study has been completed.

First Received on March 28, 2006. Last Updated on December 15, 2006 History of Changes

Sponsor:	Teva Branded Pharmaceutical Products, R&D Inc.
Information provided by:	Teva Branded Pharmaceutical Products, R&D Inc.
ClinicalTrials.gov Identifier:	NCT00308685

Purpose

This study is designed to evaluate the repeat-dose safety and effectiveness of a bronchodilator inhaler relative to placebo (inactive drug inhaler) in children aged 4-11 years with asthma. The dosing period lasts three weeks and starts following a three-week run-in period.

Condition	Intervention	Phase
Asthma	Drug: Albuterol	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Albuterol Levalbuterol hydrochloride Albuterol sulfate Levalbuterol tartrate

U.S. FDA Resources

Further study details as provided by Teva Branded Pharmaceutical Products, R&D Inc.:

Study Start Date:

April 2006

Eligibility

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

Criteria

Inclusion Criteria:

Persistent asthma of a minimum of six months duration that has been stable for at least four weeks prior to screening
Male and female children aged 4-11 years, inclusive, with predicted forced expiratory volume in 1 second (FEV1) 60-90%
Ability to perform spirometry
Demonstrate 12% airways reversibility

Exclusion Criteria:

Require continuous treatment with beta-blockers, monoamine oxidase inhibitors, tricyclic antidepressants, anticholinergics, and/or systemic corticosteroids
Presence of any non-asthmatic clinically-significant acute or uncontrolled chronic diseases

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00308685

Locations

United States, Arkansas
Little Rock Allergy and Asthma
Little Rock, Arkansas, United States, 72205-4565
United States, California
Allergy & Asthma Specialist Medical Group
Huntington Beach, California, United States, 92647
Allergy & Asthma Associates of Santa Clara Valley Research Center
San Jose, California, United States, 95117
United States, Colorado
William Storms Medical Research
Colorado Springs, Colorado, United States, 80907
Colorado Allergy and Asthma Centers, PC
Denver, Colorado, United States, 80230
Colorado Allergy and Asthma Centers, PC
Englewood, Colorado, United States, 80112
Colorado Allergy and Asthma Centers, PC
Lakewood, Colorado, United States, 80401
United States, Georgia
Southern Allergy & Asthma, PC
Savannah, Georgia, United States, 31405
United States, Illinois
Sneeze, Wheeze & Itch Associates, Inc.
Normal, Illinois, United States, 61761
United States, Minnesota
Clinical Research Institute
Minneapolis, Minnesota, United States, 55402
United States, Nebraska
The Asthma & Allergy Center, PC
Papillion, Nebraska, United States, 68046
United States, Ohio
Allergy and Respiratory Center
Canton, Ohio, United States, 44718
United States, Oklahoma
Allergy, Asthma & Clinical Research Center
Oklahoma City, Oklahoma, United States, 73120
United States, Texas
Pediatric Pulmonary Associates of North Texas
Dallas, Texas, United States, 75230

Sponsors and Collaborators

Teva Branded Pharmaceutical Products, R&D Inc.

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00308685 History of Changes
Other Study ID Numbers:	IXR-303-25-167
Study First Received:	March 28, 2006
Last Updated:	December 15, 2006
Health Authority:	United States: Food and Drug Administration

Keywords provided by Teva Branded Pharmaceutical Products, R&D Inc.:

Asthma
Pediatric asthma

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Bronchodilator Agents
Tocolytic Agents
Reproductive Control Agents

Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on February 12, 2012