A Safety, Efficacy and Tolerability Study in Pediatric Subjects With Asthma - Full Text View

Sponsored by:	Sepracor, Inc.
Information provided by:	Sepracor, Inc.
ClinicalTrials.gov Identifier:	NCT00809757

Purpose

A Safety, Efficacy, and Tolerability Study of Daily Dosing with Levalbuterol Tartrate HFA MDI and Placebo in Subjects Aged Birth to <48 Months with Asthma.

Condition	Intervention	Phase
Asthma	Drug: Levalbuterol Drug: Levalbuterol UDV TID Drug: Placebo	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), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Safety, Efficacy, and Tolerability Study of Daily Dosing With Levalbuterol Tartrate HFA MDI and Placebo in Subjects Aged Birth to <48 Months With Asthma

Further study details as provided by Sepracor, Inc.:

Primary Outcome Measures:

Change from baseline to Visit 4 in the mean daily composite score based on the Pediatric Asthma Caregiver Assessments [ Time Frame: Days 0,14,28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes from baseline to Visits 3 and 4 in the mean daily composite score based on the daytime and nighttime asthma symptom scores [ Time Frame: Days 0,14,28 ] [ Designated as safety issue: No ]
Change and percent change in the in-clinic PEF value from study baseline (Visit 2 predose) to postdose timepoints at Visit 2,3,4 timepoints in those subjects aged 24 to <48 months able to perform acceptable and reproducible PEF man [ Time Frame: Days 0,14,28 ] [ Designated as safety issue: No ]
Change and percent change in the at-home mean daily PEF value from study baseline (mean of the daily PEF values from Visit 1 and 2) to Visits 3 and 4 (mean of the daily PEF values in the week prior to the visit) in subjects aged 24 to <48 month [ Time Frame: Days -7, 0, 14, 28 ] [ Designated as safety issue: No ]

Estimated Enrollment:	195
Study Start Date:	December 2008
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 90 ug Levalbuterol (2 actuations)	Drug: Levalbuterol 90 ug Levalbuterol (2 actuations)
2: Active Comparator 0.31 ug Levalbuterol UDV TID	Drug: Levalbuterol UDV TID 0.31 ug Levalbuterol UDV TID
3: Placebo Comparator Placebo	Drug: Placebo Placebo (2 actuations)

Detailed Description:

This is a modified-blind, randomized, placebo-controlled, multicenter, parallel-group trial of levalbuterol HFA MDI administered using a facemask and holding chamber in subjects birth to <48 months with asthma.

Eligibility

Ages Eligible for Study:	up to 48 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject's parent/legal guardian must give written informed consent, including privacy authorization, prior to study participation. Complete documentation regarding the consent process must be recorded in the case report form (CRF) and source documentation.
Subject's parent/legal guardian must be willing and able to comply with the study procedures and visit schedules.
Subject, male or female, must be between the ages of birth and <48 months, exclusive, at the time of consent.
Subjects 24 to <48 months of age must have a history of physician-diagnosed asthma (defined as at least 3 episodes of respiratory symptoms consistent with asthma symptoms including, but not limited to, cough, wheeze, or dyspnea). Subjects 0 to <24 months of age must have a history of 3 episodes of respiratory symptoms that in the judgement of the investigator could be consistent with asthma or reactive airways disease
Subject must be in good health and not affected by any other chronic conditions, including respiratory disorders other than asthma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00809757

Locations

United States, California
	Recruiting
Orange, California, United States, 92868
Contact: Central Contact 1-866-503-6351
United States, Florida
	Recruiting
Fort Walton Beach, Florida, United States, 32547
Contact: Central Contact 1-866-503-6351
United States, Nebraska
	Recruiting
Omaha, Nebraska, United States, 68130
Contact: Central Contact 1-866-503-6351
United States, Virginia
	Recruiting
Richmond, Virginia, United States, 23229
Contact: Central Contact 1-866-503-6351

Sponsors and Collaborators

Sepracor, Inc.

More Information

Responsible Party:	Sepracor ( Levalbuterol Medical Director )
Study ID Numbers:	051-359
Study First Received:	December 15, 2008
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00809757
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sepracor, Inc.:

Asthma

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 14, 2009