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

Sponsor:	Teva Branded Pharmaceutical Products, R&D Inc.
Information provided by:	Teva Branded Pharmaceutical Products, R&D Inc.
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 Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Phase 3 Study to Evaluate the Chronic-dose Safety and Efficacy of Albuterol-HFA-MDI Relative to Placebo in Pediatric Asthmatics

Resource links provided by NLM:

MedlinePlus related topics: Asthma

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

U.S. FDA Resources

Further study details as provided by Teva Branded Pharmaceutical Products, R&D Inc.:

Primary Outcome Measures:

The Maximum Percent Change From Baseline in the Forced Expiratory Volume in One Second (FEV1) Observed up to 2 Hours Following Completion of Dosing Using Day 22 Baseline [ Time Frame: Day 1, Day 22, up to 2 hours following completion of dosing on Day 22 ] [ Designated as safety issue: No ]
Maximum Percent Change in Peak Expiratory Flow (PEF) Observed up to 2 Hours Following Completion of Dosing Using Day 22 Baseline. [ Time Frame: Day 22 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Baseline Adjusted Area-under-the-effect-curve for Percent of Predicted FEV1 Over 6 Hours Post Dose [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
Baseline-adjusted area-under-the Effect Curve for Percent of Predicted FEV1 Over 6 Hours Post-dose on Day 22. [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
Baseline-adjusted area-under-the Effect Curve for PEF Over 6 Hours Post-dose. [ Time Frame: Day 1, Day 22 ] [ Designated as safety issue: No ]
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. [ Time Frame: Day 1, Day 22, Day 22 with LOCF ] [ Designated as safety issue: No ]
The Time (in Minutes) to Response Onset: the First Time That an Increase From Baseline in PEF of at Least 15% is Noted [ Time Frame: Day 1, Day 22, day 22 with LOCF ] [ Designated as safety issue: No ]
The Time (in Minutes) to Response Onset: the First Time That an Increase From Baseline in FEVl of at Least 12% is Noted [ Time Frame: Day 1, Day 22, day 22 with LOCF ] [ Designated as safety issue: No ]
The Time (in Minutes) to Response Onset: the First Time That an Increase From Baseline in PEF of at Least 12% is Noted [ Time Frame: Day 1, Day 22, Day 22 with LOCF ] [ Designated as safety issue: No ]
The Time (in Minutes) to Maximum FEVl [ Time Frame: Day 1, Day 22 with LOCF ] [ Designated as safety issue: No ]
The Time (in Minutes) to Maximum PEF [ Time Frame: Day 1, Day 22 with LOCF ] [ Designated as safety issue: No ]
The Duration of Effect (in Hours) as Measured From the Time of Dosing to the Time at Which the FEVl First Decreases Below 15% [ Time Frame: Day 1, Day 22, Day 22 with LOCF ] [ Designated as safety issue: No ]
The Duration of Effect (in Hours) as Measured From the Time of Dosing the Time at Which the FEVl First Decreases Below 12% [ Time Frame: Day 1, Day 22, Day 22 with LOCF ] [ Designated as safety issue: No ]
The Duration of Effect (in Hours) as Measured From the Time of Dosing the Time at Which the PEF First Decreases Below 15% [ Time Frame: Day 1, Day 22, Day 22 with LOCF ] [ Designated as safety issue: No ]
The Duration of Effect (in Hours) as Measured From the Time of Dosing the Time at Which the PEF First Decreases Below 12% [ Time Frame: Day 1, Day 22 , day 22 with LOCF ] [ Designated as safety issue: No ]
Highest Daily Asthma Symptom Scores by Study Week [ Time Frame: Week 1, Week 2, Week 3 ] [ Designated as safety issue: No ]
The Number of Asthma-related Nocturnal Awakenings Per Week Requiring the Use of Rescue Medication [ Time Frame: Week 1, Week 2, Week 3 ] [ Designated as safety issue: No ]
The Daily a.m. Pre-dose PEF [ Time Frame: Week 1, Week 2, Week 3 ] [ Designated as safety issue: No ]
The Average Number of Puffs of Rescue Medication Per 24 Hour Period [ Time Frame: Week 1, Week 2, Week 3 ] [ Designated as safety issue: No ]

Enrollment:	103
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
Experimental: 180 mcg of Albuterol Dosing with 180 mcg of albuterol in a metered-dose inhaler (MDI) utilizing a hydrofluoroalkane (HFA) propellant. (Hereafter noted as "Albuterol HFA-MDI.")	Drug: Albuterol Albuterol HFA MDI 180 mcg
Placebo Comparator: Placebo A placebo of a metered-dose inhaler (MDI) utilizing a hydrofluoroalkane (HFA) propellant. (Hereafter noted as "Placebo-HFA-MDI.")	Drug: Placebo Placebo HFA MDI

Detailed Description:

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 (Albuterol-HFA-MDI)

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
Pediatric Care Medical Group, Inc.
Huntington Beach, California, United States, 92647
California Allergy & Asthma Medical Group
Palmdale, California, United States, 93551
Center for Clinical Trials, LLC
Paramount, California, United States, 90723
Integrated Research Group, Inc
Riverside, California, United States, 92506
Center for Clinical Trials of Sacramento
Sacramento, California, United States, 95823
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
Asthma & Allergy Associates, PC
Elmira, New York, United States, 14901
ENT & Allergy Associates
Newburgh, New York, United States, 12550
St. Elizabeth's Children Health Center
Utica, New York, United States, 13502
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

Teva Branded Pharmaceutical Products, R&D Inc.

Investigators

Study Director:

Teva Study Physician MD

Teva

More Information

No publications provided

Responsible Party:	Ivax Research, LLC
ClinicalTrials.gov Identifier:	NCT00577655 History of Changes
Other Study ID Numbers:	IXR-302-25-105
Study First Received:	December 18, 2007
Results First Received:	July 21, 2009
Last Updated:	October 27, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Teva Branded Pharmaceutical Products, R&D Inc.:

Pediatric, asthma, albuterol-HFA and Placebo

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs

Pharmacologic Actions
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on February 12, 2012