Chronic-Dose Safety and Efficacy Study of Albuterol-HFA-BAI in Pediatric Asthmatics

Completed · Phase 3 · Has a placebo group

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT00308685

Run by

Teva Branded Pharmaceutical Products R&D, Inc.

People needed

95

Starts

2006-06-10

Expected to finish

2006-12-04

Last updated by the study team

2022-04-01

Who can join

Age: 4 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Little Rock Allergy and Asthma — Little Rock, Arkansas, United States
• Allergy & Asthma Specialist Medical Group — Huntington Beach, California, United States
• Allergy & Asthma Associates of Santa Clara Valley Research Center — San Jose, California, United States
• William Storms Medical Research — Colorado Springs, Colorado, United States
• Colorado Allergy and Asthma Centers, PC — Denver, Colorado, United States
• Colorado Allergy and Asthma Centers, PC — Englewood, Colorado, United States
• Colorado Allergy and Asthma Centers, PC — Lakewood, Colorado, United States
• Southern Allergy & Asthma, PC — Savannah, Georgia, United States
• Sneeze, Wheeze & Itch Associates, Inc. — Normal, Illinois, United States
• Clinical Research Institute — Minneapolis, Minnesota, United States
• The Asthma & Allergy Center, PC — Papillion, Nebraska, United States
• Allergy and Respiratory Center — Canton, Ohio, United States
• Allergy, Asthma & Clinical Research Center — Oklahoma City, Oklahoma, United States
• Pediatric Pulmonary Associates of North Texas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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