Official Title: “Phase 3 Study to Evaluate the Chronic-Dose Safety and Efficacy of Albuterol-HFA-MDI Relative to Placebo in Pediatric Asthmatics”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: July 2008

Eligible patients will be randomized to receive one of the following two treatments four times a day for 21 days:

Placebo-HFA-MDI (Albuterol 0 mcg) Albuterol-HFA-MDI (Albuterol 180 mcg)

Intervention(s) in this Clinical Trial

• Drug: Albuterol-HFA-MDI and placebo
  • Placebo-HFA-MDI (albuterol, 0 mcg) Albuterol-HFA-MDI (albuterol, 180 mcg)
• Drug: Albuterol-HFA-MDI
  • Albuterol-HFA-MDI 180 mcg

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Albuterol-HFA-MDI
• Placebo Comparator: 2
  • Placebo-HFA-MDI

Primary Measures

• The primary objective is to evaluate the chronic-dose safety and efficacy of Albuterol-HFA-MDI relative to placebo in pediatric asthmatics.
  • Time Frame: 21 days of treatment
    Safety Issue?: Yes

Secondary Measures

• Baseline-adjusted area-under-the effect curve for percent of predicted FEV1 and PEF over six hours post-dose.
  • Time Frame: 6-hours
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 4 Years

Maximum Age for this Clinical Trial: 11 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: IVAX Research LLC

Overall Clinical Trial Officials and Contacts

Teva Study Physician MD Study Director Teva R&D Initiative  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00577655

Study ID Number: IXR-302-25-105

ClinicalTrials.gov Identifier: NCT00577655

Health Authority: United States: Food and Drug Administration