Albuterol HFA MDI in Pediatric Participants With Asthma

Teva Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Proventil® HFA; Drug: Albuterol; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00577655

IXR-302-25-105

Details and patient eligibility

About

The primary objective of this study is to evaluate the chronic-dose and efficacy of Albuterol-HFA-MDI relative to placebo in pediatric asthmatics.

Enrollment: 103 patients

Sex: All

Ages: 4 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female child aged 4-11 years, inclusive Asthma of a minimum of six months duration that has been stable for at least four weeks prior to screening.

Exclusion criteria

• Hospitalization for acute asthma exacerbation greater than two years in 12 months prior to screening and/or received ER treatment or hospitalization for asthma exacerbation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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103 participants in 2 patient groups, including a placebo group

Albuterol

Experimental group

Description:

Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days. HFA-MDI refers to a metered-dose inhaler (MDI) utilizing a hydrofluoroalkane (HFA) propellant.

Treatment:

Drug: Albuterol

Drug: Proventil® HFA

Placebo

Placebo Comparator group

Description:

A placebo of a metered-dose inhaler (MDI) utilizing a hydrofluoroalkane (HFA) propellant. (Hereafter noted as "Placebo-HFA-MDI.")

Treatment:

Drug: Placebo

Drug: Proventil® HFA