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

Condition(s) targeted: Asthma

Intervention: Albuterol (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: IVAX Research LLC

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.

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Minimum age: 4 Years. Maximum age: 11 Years. Gender(s): Both.

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

Little Rock Allergy and Asthma, Little Rock, Arkansas 72205-4565, United States

Allergy & Asthma Associates of Santa Clara Valley Research Center, San Jose, California 95117, United States

Allergy & Asthma Specialist Medical Group, Huntington Beach, California 92647, United States

Colorado Allergy and Asthma Centers, PC, Englewood, Colorado 80112, United States

Colorado Allergy and Asthma Centers, PC, Lakewood, Colorado 80401, United States

Colorado Allergy and Asthma Centers, PC, Denver, Colorado 80230, United States

William Storms Medical Research, Colorado Springs, Colorado 80907, United States

Southern Allergy & Asthma, PC, Savannah, Georgia 31405, United States

Sneeze, Wheeze & Itch Associates, Inc., Normal, Illinois 61761, United States

Clinical Research Institute, Minneapolis, Minnesota 55402, United States

The Asthma & Allergy Center, PC, Papillion, Nebraska 68046, United States

Allergy and Respiratory Center, Canton, Ohio 44718, United States

Allergy, Asthma & Clinical Research Center, Oklahoma City, Oklahoma 73120, United States

Pediatric Pulmonary Associates of North Texas, Dallas, Texas 75230, United States

Starting date: April 2006
Last updated: December 15, 2006