Chronic-Dose Safety and Efficacy Study of an Albuterol Metered Dose Inhaler (MDI) Inhaler Using a Hydrofluoroalkane (HFA) Propellant In Pediatric Asthmatics
Information source: Teva Branded Pharmaceutical Products, R&D Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Albuterol (Drug); Placebo (Drug)
Phase: Phase 3
Sponsored by: Teva Branded Pharmaceutical Products, R&D Inc.
Official(s) and/or principal investigator(s):
Teva Study Physician MD, Study Director, Affiliation: TEVA
The primary objective of this study is to evaluate the chronic-dose and efficacy of
Albuterol-HFA-MDI relative to placebo in pediatric asthmatics.
Official title: Phase 3 Study to Evaluate the Chronic-dose Safety and Efficacy of Albuterol-HFA-MDI Relative to Placebo in Pediatric Asthmatics
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Maximum Percent Change From Baseline
Maximum Percent Change in Peak Expiratory Flow (PEF)
Baseline Adjusted Area-under-the-effect-curve for Percent of Predicted FEV1 Over 6 Hours Post Dose
Baseline-adjusted area-under-the Effect Curve for Percent of Predicted FEV1 Over 6 Hours Post-dose on Day 22.
Baseline-adjusted area-under-the Effect Curve for PEF Over 6 Hours Post-dose.
The Time (in Minutes) to Response Onset: the First Time That an Increase From Baseline in FEVl of at Least 15% is Noted in Participants Who Responded to the Medication.
The Time (in Minutes) to Response Onset: the First Time That an Increase From Baseline in PEF of at Least 15% is Noted
The Time (in Minutes) to Response Onset: the First Time That an Increase From Baseline in FEVl of at Least 12% is Noted
The Time (in Minutes) to Response Onset: the First Time That an Increase From Baseline in PEF of at Least 12% is Noted
The Time (in Minutes) to Maximum FEVl
The Time (in Minutes) to Maximum PEF
The Duration of Effect (in Hours) as Measured From the Time of Dosing to the Time at Which the FEVl First Decreases Below 15%
The Duration of Effect (in Hours) as Measured From the Time of Dosing the Time at Which the FEVl First Decreases Below 12%
The Duration of Effect (in Hours) as Measured From the Time of Dosing the Time at Which the PEF First Decreases Below 15%
The Duration of Effect (in Hours) as Measured From the Time of Dosing the Time at Which the PEF First Decreases Below 12%
Highest Daily Asthma Symptom Scores by Study Week
The Number of Asthma-related Nocturnal Awakenings Per Week Requiring the Use of Rescue Medication
The Daily a.m. Pre-dose PEF
The Average Number of Puffs of Rescue Medication Per 24 Hour Period
Eligible patients will be randomized to receive one of the following two treatments four
times a day for 21 days:
Placebo in a metered-dose inhaler using a hydrofluoroalkane propellant (Placebo-HFA-MDI).
180 mcg of Albuterol in a metered-dose inhaler using a hydrofluoroalkane propellant
Minimum age: 4 Years.
Maximum age: 11 Years.
- 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.
- Hospitalization for acute asthma exacerbation greater than two years in 12 months
prior to screening and/or received ER treatment or hospitalization for asthma
Locations and Contacts
Pediatric Care Medical Group, Inc., Huntington Beach, California 92647, United States
California Allergy & Asthma Medical Group, Palmdale, California 93551, United States
Center for Clinical Trials, LLC, Paramount, California 90723, United States
Integrated Research Group, Inc, Riverside, California 92506, United States
Center for Clinical Trials of Sacramento, Sacramento, California 95823, United States
Carlos Piniella, MD, Miami, Florida 33157, United States
Sneeze, Wheeze & Itch Associates, Inc., Normal, Illinois 61761, United States
Asthma & Allergy Associates, PC, Elmira, New York 14901, United States
ENT & Allergy Associates, Newburgh, New York 12550, United States
St. Elizabeth's Children Health Center, Utica, New York 13502, United States
Regional Allergy & Asthma Consultants, Asheville, North Carolina 28801, United States
Clinical Research Institute of Southern Oregan, PC, Medford, Oregon 97504, United States
Virginia Adult & Pediatric Allergy & Asthma, Richmond, Virginia 23229, United States
Starting date: August 2007
Last updated: April 11, 2012