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

Teva Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Placebo; Drug: Albuterol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00308685

IXR-303-25-167

Details and patient eligibility

About

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.

Enrollment: 95 patients

Sex: All

Ages: 4 to 11 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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95 participants in 2 patient groups, including a placebo group

Albuterol-HFA-BAI

Experimental group

Description:

ProAir(TM) HFA, Breath Actuated Inhalation Aerosol

Treatment:

Drug: Albuterol

Placebo-HFA-BAI

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo