Albuterol HFA MDI in Pediatric Participants With Asthma
NCT ID: NCT00577655
Last Updated: 2021-11-12
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
103 participants
INTERVENTIONAL
2007-08-31
2008-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Albuterol
Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days. HFA-MDI refers to a metered-dose inhaler (MDI) utilizing a hydrofluoroalkane (HFA) propellant.
Albuterol
Albuterol HFA MDI 180 mcg four times a day (q.i.d) for a total daily albuterol dose of 720 mcg for 21 days.
Proventil® HFA
Proventil® HFA (albuterol sulfate) Inhalation Aerosol (Key Pharmaceuticals) was used as rescue medication in this study. The rescue medication was over-labeled with instructions for emergency use in which subjects were instructed to self-administer up to two puffs every 20 minutes to a maximum of six puffs for any given episode while attempting to seek medical assistance.
Placebo
A placebo of a metered-dose inhaler (MDI) utilizing a hydrofluoroalkane (HFA) propellant. (Hereafter noted as "Placebo-HFA-MDI.")
Placebo
Placebo HFA MDI four times a day (q.i.d) for 21 days.
Proventil® HFA
Proventil® HFA (albuterol sulfate) Inhalation Aerosol (Key Pharmaceuticals) was used as rescue medication in this study. The rescue medication was over-labeled with instructions for emergency use in which subjects were instructed to self-administer up to two puffs every 20 minutes to a maximum of six puffs for any given episode while attempting to seek medical assistance.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Albuterol
Albuterol HFA MDI 180 mcg four times a day (q.i.d) for a total daily albuterol dose of 720 mcg for 21 days.
Placebo
Placebo HFA MDI four times a day (q.i.d) for 21 days.
Proventil® HFA
Proventil® HFA (albuterol sulfate) Inhalation Aerosol (Key Pharmaceuticals) was used as rescue medication in this study. The rescue medication was over-labeled with instructions for emergency use in which subjects were instructed to self-administer up to two puffs every 20 minutes to a maximum of six puffs for any given episode while attempting to seek medical assistance.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
4 Years
11 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Teva Study Physician MD
Role: STUDY_DIRECTOR
Teva Branded Pharmaceutical Products R&D, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Pediatric Care Medical Group, Inc.
Huntington Beach, California, United States
California Allergy & Asthma Medical Group
Palmdale, California, United States
Center for Clinical Trials, LLC
Paramount, California, United States
Integrated Research Group, Inc
Riverside, California, United States
Center for Clinical Trials of Sacramento
Sacramento, California, United States
Carlos Piniella, MD
Miami, Florida, United States
Sneeze, Wheeze & Itch Associates, Inc.
Normal, Illinois, United States
Asthma & Allergy Associates, PC
Elmira, New York, United States
ENT & Allergy Associates
Newburgh, New York, United States
St. Elizabeth's Children Health Center
Utica, New York, United States
Regional Allergy & Asthma Consultants
Asheville, North Carolina, United States
Clinical Research Institute of Southern Oregan, PC
Medford, Oregon, United States
Virginia Adult & Pediatric Allergy & Asthma
Richmond, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IXR-302-25-105
Identifier Type: -
Identifier Source: org_study_id