Chronic-Dose Safety and Efficacy Study of Albuterol-HFA-MDI In Pediatric Asthmatics - Full Text View

Sponsored by:	IVAX Research LLC
Information provided by:	IVAX Research LLC
ClinicalTrials.gov Identifier:	NCT00577655

Purpose

The primary objective of this study is to evaluate the chronic-dose and efficacy of Albuterol-HFA-MDI relative to placebo in pediatric asthmatics.

Condition	Intervention	Phase
Asthma	Drug: Albuterol-HFA-MDI and placebo Drug: Albuterol-HFA-MDI	Phase III

MedlinePlus related topics: Asthma

Drug Information available for: Albuterol sulfate Albuterol Levalbuterol hydrochloride Levalbuterol tartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase 3 Study to Evaluate the Chronic-Dose Safety and Efficacy of Albuterol-HFA-MDI Relative to Placebo in Pediatric Asthmatics

Further study details as provided by IVAX Research LLC:

Primary Outcome Measures:

The primary objective is to evaluate the chronic-dose safety and efficacy of Albuterol-HFA-MDI relative to placebo in pediatric asthmatics. [ Time Frame: 21 days of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Baseline-adjusted area-under-the effect curve for percent of predicted FEV1 and PEF over six hours post-dose. [ Time Frame: 6-hours ] [ Designated as safety issue: Yes ]

Enrollment:	104
Study Start Date:	August 2007
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Albuterol-HFA-MDI	Drug: Albuterol-HFA-MDI Albuterol-HFA-MDI 180 mcg
2: Placebo Comparator Placebo-HFA-MDI	Drug: Albuterol-HFA-MDI and placebo Placebo-HFA-MDI (albuterol, 0 mcg) Albuterol-HFA-MDI (albuterol, 180 mcg)

Detailed Description:

Eligible 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

Ages Eligible for Study:	4 Years to 11 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00577655

Locations

United States, California
Center for Clinical Trials of Sacramento
Sacramento, California, United States, 95823
Center for Clinical Trials, LLC
Paramount, California, United States, 90723
Integrated Research Group, Inc
Riverside, California, United States, 92506
Pediatric Care Medical Group, Inc.
Huntington Beach, California, United States, 92647
California Allergy & Asthma Medical Group
Palmdale, California, United States, 93551
United States, Florida
Carlos Piniella, MD
Miami, Florida, United States, 33157
United States, Illinois
Sneeze, Wheeze & Itch Associates, Inc.
Normal, Illinois, United States, 61761
United States, New York
St. Elizabeth's Children Health Center
Utica, New York, United States, 13502
Asthma & Allergy Associates, PC
Elmira, New York, United States, 14901
ENT & Allergy Associates
Newburgh, New York, United States, 12550
United States, North Carolina
Regional Allergy & Asthma Consultants
Asheville, North Carolina, United States, 28801
United States, Oregon
Clinical Research Institute of Southern Oregan, PC
Medford, Oregon, United States, 97504
United States, Virginia
Virginia Adult & Pediatric Allergy & Asthma
Richmond, Virginia, United States, 23229

Sponsors and Collaborators

IVAX Research LLC

Investigators

Study Director:

Teva Study Physician MD

Teva R&D Initiative

More Information

Responsible Party:	Ivax Research, LLC ( Ivax Research, LLC )
Study ID Numbers:	IXR-302-25-105
Study First Received:	December 18, 2007
Last Updated:	August 4, 2008
ClinicalTrials.gov Identifier:	NCT00577655
Health Authority:	United States: Food and Drug Administration

Keywords provided by IVAX Research LLC:

Pediatric, asthma, albuterol-HFA and Placebo

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases

Albuterol
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Bronchial Diseases
Immune System Diseases
Adrenergic beta-Agonists
Physiological Effects of Drugs
Anti-Asthmatic Agents

Reproductive Control Agents
Adrenergic Agonists
Pharmacologic Actions
Tocolytic Agents
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009