Chronic-Dose Safety and Efficacy Study of Albuterol-HFA-MDI In Pediatric Asthmatics
Information source: IVAX Research LLC
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Albuterol-HFA-MDI and placebo (Drug); Albuterol-HFA-MDI (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: IVAX Research LLC
Summary
The primary objective of this study is to evaluate the chronic-dose and efficacy of
Albuterol-HFA-MDI relative to placebo in pediatric asthmatics.
Clinical Details
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: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The primary objective is to evaluate the chronic-dose safety and efficacy of Albuterol-HFA-MDI relative to placebo in pediatric asthmatics.
Secondary outcome: Baseline-adjusted area-under-the effect curve for percent-=prdicted FEV1 and PEF over six hours post-dose.
Detailed description:
Eligiable 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)
Eligibility
Minimum age: 4 Years.
Maximum age: 11 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Center for Clinical Trials of Sacramento, Sacramento, California 95823, United States
Center for Clinical Trials, LLC, Paramount, California 90723, United States
Integrated Research Group, Inc, Riverside, California 92506, United States
Pediatric Care Medical Group, Inc., Huntington Beach, California 92647, United States
California Allergy & Asthma Medical Group, Palmdale, California 93551, United States
Carlos Piniella, MD, Miami, Florida 33157, United States
Sneeze, Wheeze & Itch Associates, Inc., Normal, Illinois 61761, United States
St. Elizabeth's Children Health Center, Utica, New York 13502, United States
Asthma & Allergy Associates, PC, Elmira, New York 14901, United States
ENT & Allergy Associates, Newburgh, New York 12550, 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
Additional Information
Starting date: August 2007
Ending date: August 2008
Last updated: June 9, 2008
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