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

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

MedlinePlus related topics:

Asthma

Drug Information available for:

Albuterol sulfate Albuterol Levalbuterol hydrochloride Levalbuterol tartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by IVAX Research LLC:

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 Associates of Santa Clara Valley Research Center
	San Jose, California, United States, 95117
	Allergy & Asthma Specialist Medical Group
	Huntington Beach, California, United States, 92647

United States, Colorado
	William Storms Medical Research
	Colorado Springs, Colorado, United States, 80907
	Colorado Allergy and Asthma Centers, PC
	Lakewood, Colorado, United States, 80401
	Colorado Allergy and Asthma Centers, PC
	Denver, Colorado, United States, 80230
	Colorado Allergy and Asthma Centers, PC
	Englewood, Colorado, United States, 80112

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

IVAX Research LLC

More Information

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