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

NCT00308685 | Completed Phase 3 Results FDA Drug

• 1 other identifier: IXR-303-25-167
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 14

Brief Summary

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.

Conditions

Asthma

Keywords

Asthma; Pediatric asthma

Outcome Measures

Primary Outcomes (1)

• 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

  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 Outcomes (1)

• Baseline-Adjusted Area Under the Percent-Predicted FEV1 Versus Time Curve Over 6 Hours (PPFEV1 AUEC0-6) at Day 22

  Predose (30 and 5 minutes) and 15, 30, 45, 60, 120, 240, and 360 minutes postdose at Day 22

Study Arms (2)

Albuterol-HFA-BAI

EXPERIMENTAL

ProAir(TM) HFA, Breath Actuated Inhalation Aerosol

Drug: Albuterol

Placebo-HFA-BAI

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Albuterol DRUG

Albuterol 90mcg

Albuterol-HFA-BAI

Placebo DRUG

Placebo

Placebo-HFA-BAI

Eligibility Criteria

• Age: 4 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

Study Sites (14)

Little Rock Allergy and Asthma

Little Rock, Arkansas, 72205-4565, United States

Location

Allergy & Asthma Specialist Medical Group

Huntington Beach, California, 92647, United States

Location

Allergy & Asthma Associates of Santa Clara Valley Research Center

San Jose, California, 95117, United States

Location

William Storms Medical Research

Colorado Springs, Colorado, 80907, United States

Location

Colorado Allergy and Asthma Centers, PC

Denver, Colorado, 80230, United States

Location

Colorado Allergy and Asthma Centers, PC

Englewood, Colorado, 80112, United States

Location

Colorado Allergy and Asthma Centers, PC

Lakewood, Colorado, 80401, United States

Location

Southern Allergy & Asthma, PC

Savannah, Georgia, 31405, United States

Location

Sneeze, Wheeze & Itch Associates, Inc.

Normal, Illinois, 61761, United States

Location

Clinical Research Institute

Minneapolis, Minnesota, 55402, United States

Location

The Asthma & Allergy Center, PC

Papillion, Nebraska, 68046, United States

Location

Allergy and Respiratory Center

Canton, Ohio, 44718, United States

Location

Allergy, Asthma & Clinical Research Center

Oklahoma City, Oklahoma, 73120, United States

Location

Pediatric Pulmonary Associates of North Texas

Dallas, Texas, 75230, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products R&D, Inc.

USMedInfo@tevapharm.com

888-483-8279

Study Officials

• Teva Medical Expert, M.D.

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2006
• First Posted: March 30, 2006
• Study Start: June 10, 2006
• Primary Completion: December 4, 2006
• Study Completion: December 4, 2006
• Last Updated: April 1, 2022
• Results First Posted: February 24, 2022

Record last verified: 2022-03

Locations

US (14)