Clinical trial NCT00308685: Chronic-Dose Safety and Efficacy Study of Albuterol-HFA-BAI in Pediatric Asthmatics
Official title: Chronic-Dose Safety and Efficacy Study of Albuterol-HFA-BAI (PROAIR™ HFA (Albuterol Sulfate) Breath Actuated Inhalation Aerosol) in Pediatric Asthmatics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
Pediatric asthma
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2006-03-30
Enrollment: 95
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Baseline (Predose at Day 22), 2 hours postdose at Day 22
Secondary outcomes:
measure: Baseline-Adjusted Area Under the Percent-Predicted FEV1 Versus Time Curve Over 6 Hours (PPFEV1 AUEC0-6) at Day 22
timeFrame: Predose (30 and 5 minutes) and 15, 30, 45, 60, 120, 240, and 360 minutes postdose at Day 22
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Little Rock Allergy and Asthma
state: Arkansas
city: Huntington Beach
country: United States
facility: Allergy & Asthma Specialist Medical Group
state: California
city: San Jose
country: United States
facility: Allergy & Asthma Associates of Santa Clara Valley Research Center
state: California
city: Colorado Springs
country: United States
facility: William Storms Medical Research
state: Colorado
city: Denver
country: United States
facility: Colorado Allergy and Asthma Centers, PC
state: Colorado
city: Englewood
country: United States
facility: Colorado Allergy and Asthma Centers, PC
state: Colorado
city: Lakewood
country: United States
facility: Colorado Allergy and Asthma Centers, PC
state: Colorado
city: Savannah
country: United States
facility: Southern Allergy & Asthma, PC
state: Georgia
city: Normal
country: United States
facility: Sneeze, Wheeze & Itch Associates, Inc.
state: Illinois
city: Minneapolis
country: United States
facility: Clinical Research Institute
state: Minnesota
city: Papillion
country: United States
facility: The Asthma & Allergy Center, PC
state: Nebraska
city: Canton
country: United States
facility: Allergy and Respiratory Center
state: Ohio
city: Oklahoma City
country: United States
facility: Allergy, Asthma & Clinical Research Center
state: Oklahoma
city: Dallas
country: United States
facility: Pediatric Pulmonary Associates of North Texas
state: Texas
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, M.D.
role: STUDY_DIRECTOR
References: