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

March 22, 2022 updated by: Teva Branded Pharmaceutical Products R&D, Inc.

Chronic-Dose Safety and Efficacy Study of Albuterol-HFA-BAI (PROAIR™ HFA (Albuterol Sulfate) Breath Actuated Inhalation Aerosol) in Pediatric Asthmatics

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205-4565
        • Little Rock Allergy and Asthma
    • California
      • Huntington Beach, California, United States, 92647
        • Allergy & Asthma Specialist Medical Group
      • San Jose, California, United States, 95117
        • Allergy & Asthma Associates of Santa Clara Valley Research Center
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • William Storms Medical Research
      • Denver, Colorado, United States, 80230
        • Colorado Allergy and Asthma Centers, PC
      • Englewood, Colorado, United States, 80112
        • Colorado Allergy and Asthma Centers, PC
      • Lakewood, Colorado, United States, 80401
        • Colorado Allergy and Asthma Centers, PC
    • Georgia
      • Savannah, Georgia, United States, 31405
        • Southern Allergy & Asthma, PC
    • Illinois
      • Normal, Illinois, United States, 61761
        • Sneeze, Wheeze & Itch Associates, Inc.
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
        • Clinical Research Institute
    • Nebraska
      • Papillion, Nebraska, United States, 68046
        • The Asthma & Allergy Center, PC
    • Ohio
      • Canton, Ohio, United States, 44718
        • Allergy and Respiratory Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Allergy, Asthma & Clinical Research Center
    • Texas
      • Dallas, Texas, United States, 75230
        • Pediatric Pulmonary Associates of North Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Albuterol-HFA-BAI
ProAir(TM) HFA, Breath Actuated Inhalation Aerosol
Drug: Albuterol
Albuterol 90mcg
Placebo Comparator: Placebo-HFA-BAI
Placebo
Drug: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Observed up to 2 Hours Following Completion of Dosing (FEV1max%0-2) at Day 22
Time Frame: Baseline (Predose at Day 22), 2 hours postdose at Day 22
The baseline FEV1 was defined as the average of the two predose measurements ( at -0.5 and 0.0 hour) on the test day (Day 22). The mean was obtained from the analysis of covariance (ANCOVA) adjusted for baseline FEV1 and the pooled investigational center.
Baseline (Predose at Day 22), 2 hours postdose at Day 22

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline-Adjusted Area Under the Percent-Predicted FEV1 Versus Time Curve Over 6 Hours (PPFEV1 AUEC0-6) at Day 22
Time Frame: Predose (30 and 5 minutes) and 15, 30, 45, 60, 120, 240, and 360 minutes postdose at Day 22
Baseline-adjusted PPFEV1 AUEC0-6 on Study Day 22 was determined using both the Day 1 and Day 22 baselines.
Predose (30 and 5 minutes) and 15, 30, 45, 60, 120, 240, and 360 minutes postdose at Day 22

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2006

Primary Completion (Actual)

December 4, 2006

Study Completion (Actual)

December 4, 2006

Study Registration Dates

First Submitted

March 28, 2006

First Submitted That Met QC Criteria

March 28, 2006

First Posted (Estimate)

March 30, 2006

Study Record Updates

Last Update Posted (Actual)

April 1, 2022

Last Update Submitted That Met QC Criteria

March 22, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IXR-303-25-167

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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