Study of Daily Dosing With Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects With Asthma - Full Text View

Sponsor:	Sepracor, Inc.
Information provided by:	Sepracor, Inc.
ClinicalTrials.gov Identifier:	NCT00073814

Purpose

Study of Daily Dosing with Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects with Asthma

Condition	Intervention	Phase
Asthma	Drug: Levalbuterol tartrate MDI Drug: racemic albuterol MDI Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	An Efficacy, Safety, and Tolerability Study of Daily Dosing With Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects With Asthma

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 Sepracor, Inc.:

Primary Outcome Measures:

was peak percent change in FEV1 from visit predose averaged over the double-blind period [ Time Frame: Week 0, 2, 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

under the FEV1 percent change from visit predose curve averaged over the double-blind period [ Time Frame: Week 0, 2, 4 ] [ Designated as safety issue: No ]
peak change and peak percent change in FEV1 from visit predose to each visit [ Time Frame: Week 0, 2, 4 ] [ Designated as safety issue: No ]
peak change in FEV1 from visit predose to each visit [ Time Frame: Week 0, 2, 4 ] [ Designated as safety issue: No ]
peak percent change in FEV1 from study baseline over the double blind period [ Time Frame: Week 0, 2, 4 ] [ Designated as safety issue: No ]
time to peak change [ Time Frame: Week 0, 2, 4 ] [ Designated as safety issue: No ]
peak percent of predicted FEV1 at each visit and over the double-blind period [ Time Frame: Week 0, 2, 4 ] [ Designated as safety issue: No ]
area under the FEV1 percent change from predose curve at each visit [ Time Frame: Week 0, 2, 4 ] [ Designated as safety issue: No ]
area under the FEV1 percent change from study baseline curve at each visit and averaged over the double-blind period [ Time Frame: Week 0, 2, 4 ] [ Designated as safety issue: No ]
percent of predicted FEV1 AUC at each visit [ Time Frame: Week 0, 2, 4 ] [ Designated as safety issue: No ]
percent change in predose FEV1 from study baseline at each visit [ Time Frame: Week 0, 2, 4 ] [ Designated as safety issue: No ]
number and percent of responders [ Time Frame: Week 0, 2, 4 ] [ Designated as safety issue: No ]
time to onset of response and duration of response [ Time Frame: Week 0, 2, 4 ] [ Designated as safety issue: No ]

Enrollment:	80
Study Start Date:	December 2002
Study Completion Date:	June 2003
Primary Completion Date:	June 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental levalbuterol MDI 90 mcg QID	Drug: Levalbuterol tartrate MDI levalbuterol MDI 90 mcg QID
2: Active Comparator racemic albuterol MDI 190 mcg QID	Drug: racemic albuterol MDI racemic albuterol MDI 180 mcg QID
3: Placebo Comparator Placebo MDI QID	Drug: Placebo Placebo MDI QID

Detailed Description:

This was a Phase III, double-blind, randomized, placebo- and active-controlled, multicenter, parallel-group study of up to 6 weeks in duration. Seven days of QID single-blind, placebo administration (via HFA MDI) was followed by 28 days of QID, double-blind treatment. A follow-up visit was required only for subjects who had, in the opinion of the investigator, a clinically significant finding at Visit 6 /ET that would put the subject at risk. A final follow up phone evaluation was conducted 7 days after the completion of Visit 6/ET.

Eligibility

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

Criteria

Inclusion Criteria

Subject and subject's p/l guardian must be willing and able to comply with the study procedures and visit schedules
Subject, male or female, between the ages of 4 to 11 yrs
Female subjects 8 yrs or older will have a negative serum pregnancy test
Must have a documented diagnosis of asthma for a minimum of 6 months prior to study start
Must have stable baseline asthma and have been using a B-adrenergic agonist, and/or anti-asthma anti-inflammatory medication, and/or over-the-counter asthma medication for at least 6 mos. prior to study start
Must be in good health with the exception of reversible airways disease and not suffering from any chronic condition that might affect their respiratory function
Must have a chest X-ray that is not diagnostic of pneumonia, atelectasis, pulmonary fibrotic disease, pneumothorax, chronic obstructive pulmonary disease etc
Subject's p/l guardian must be able to complete the diary cards and medical event calendars reliably on a daily basis, understand dosing instructions and questionnaire completion, and demonstrate how to use the MiniWright PEF meter

Exclusion Criteria

Female subject who is pregnant or lactating
Have participated in an investigational drug study within 30 days prior to study start, or who is currently participating in another clinical trial
Schedule prevents him or her from taking the first daily dose of study medication and/or starting study visits before 9 AM
Have travel commitments during the study that would interfere with trial measurements or compliance or both
Have a history of hospitalization for asthma within 60 days prior to study start, or who is scheduled for in-patient hospitalization, including elective surgery during the course of the trial
Have a known sensitivity to levalbuterol or racemic albuterol, or any of the excipients contained in any of these formulations
Subject using any prescription drug with which albuterol sulfate administration is contraindicated
Have currently diagnosed life-threatening asthma defined as a history of asthma episodes requiring intubation, associated with hypercapnia, respiratory arrest, or hypoxic seizures within 3 mos. prior to study start
Have a history of cancer
Subject with hyperthyroidism, diabetes, hypertension, cardiac diseases or seizure disorders that currently are not well controlled by medication or that may interfere with the successful completion of this protocol
Have a history of substance abuse or drug abuse within 12 months preceding V1 or a positive urine drug screening at study start
Have a documented history of bronchopulmonary aspergillosis or any form of allergic alveolitis
Has suffered from a clinically significant upper or lower respiratory tract infection in the 2 wks prior to study start
Have a history of cigarette smoking or use of any tobacco products
Subject who is a relative of a staff member

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00073814

Hide Study Locations

Locations

United States, Alabama
Adolescent & Pediatric Associates, PC
Montgomery, Alabama, United States, 36116
United States, Arkansas
The Children's Clinic of Jonesboro, PA
Jonesboro, Arkansas, United States, 72401
United States, California
Southern California Research
Mission Viejo, California, United States, 92692
CHOC, PSF, AMC Disision of Allergy, Asthma & Immunology
Orange, California, United States, 92868
Clinical Trials of Orange County
Orange, California, United States, 92868
Allergy Associates Medical Group
San Diego, California, United States, 92120
West Coast Clinical Trials, Inc.
Signal Hill, California, United States, 90755
Asthma, Allergy & Respiratory Care Center
Long Beach, California, United States, 90808
Madera Family Medical Group
Madera, California, United States, 93637
Integrated Research Group
Corona, California, United States, 92879
Allergy & Asthma Medical Group of Diablo Valley, Inc.
Walnut Creek, California, United States, 94598
Allergy & Asthma Specialists Medical Group
Huntington Beach, California, United States, 92647
United States, Colorado
National Jewish Medical & Research Center
Denver, Colorado, United States, 80206
Asthma & Allergy Associates
Colorado Springs, Colorado, United States, 80907
United States, Georgia
Aeroallergy Research Laboratories of Savannah, Inc.
Savannah, Georgia, United States, 31406
The Allergy & Asthma Clinical Research Center
Lawrenceville, Georgia, United States, 30045
United States, Kentucky
Department of Pediatric Critical Care, Kosair Children's Hospital
Louisville, Kentucky, United States, 40202
United States, Louisiana
Dolby Providers, Inc
New Orleans, Louisiana, United States, 70127
The Pediatric Clinic
Bogalusa, Louisiana, United States, 70429
Doctor's Care
New Orleans, Louisiana, United States, 70122
United States, Missouri
Radiant Research
Bridgeton, Missouri, United States, 63044
United States, New Jersey
Essex-Morris Pediatric Group
Livingston, New Jersey, United States, 07960
Summit Pediatric Pulmonology
Summit, New Jersey, United States, 07901
Princeton Center for Clinical Research
Princeton, New Jersey, United States, 08540
United States, New Mexico
University of New Mexico, Health Sciences Center
Albuquerque, New Mexico, United States, 87131
United States, New York
Pulmonary Associates of Mobile, PC
Ithaca, New York, United States, 14850
United States, North Carolina
Regional Allergy & Asthma Consultants, PA
Asheville, North Carolina, United States, 28801
United States, Ohio
Pediatric Associates of Mt. Carmel
Cincinnati, Ohio, United States, 45245
University Hospitals of Cleveland, Rainbow Babies & Children's Hospital
Cleveland, Ohio, United States, 44106
Dr. Senders & Associates
University Heights, Ohio, United States, 44118
United States, Oklahoma
Sooner Clinical Research
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
Allergy & Asthma and Dermatology Research Center
Lake Oswego, Oregon, United States, 97035
Clinical Research Institute of Southern Oregon
Medford, Oregon, United States, 97504
Allergy Associates Research Center
Portland, Oregon, United States, 97213
United States, Pennsylvania
Bellevue Pediatric Association
Pittsburgh, Pennsylvania, United States, 15202
United States, South Carolina
Allergy & Asthma Consultants
Mt. Pleasant, South Carolina, United States, 29464
United States, Tennessee
Allergy, Asthma & Sinus Center, PC
Knoxville, Tennessee, United States, 37922
Vanderbilt University ASAP Research
Nashville, Tennessee, United States, 37203
United States, Texas
Breath of Life Research Institute
Houston, Texas, United States, 77084
Sun Research Institute
San Antonio, Texas, United States, 78205
North Texas Institute for Clinical Trials
Fort Worth, Texas, United States, 76132
Allergy & Asthma Associates
Houston, Texas, United States, 77054
Pediatric Allergy/Immunology Associates
Dallas, Texas, United States, 75230
United States, Virginia
PI- Coor Clinical Research, LLC
Burke, Virginia, United States, 22015
United States, Washington
Allergy & Asthma Associates
Kirkland, Washington, United States, 98034

Sponsors and Collaborators

Sepracor, Inc.

More Information

No publications provided

Responsible Party:	Sepracor Inc. ( Xopenex Medical Director )
Study ID Numbers:	051-354
Study First Received:	December 9, 2003
Last Updated:	June 6, 2008
ClinicalTrials.gov Identifier:	NCT00073814 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sepracor, Inc.:

levalbuterol
pediatric
asthma

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Bronchial Diseases
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Albuterol
Physiological Effects of Drugs
Reproductive Control Agents
Adrenergic Agonists
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Tocolytic Agents

Therapeutic Uses
Immune System Diseases
Adrenergic beta-Agonists
Asthma
Anti-Asthmatic Agents
Pharmacologic Actions
Autonomic Agents
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on November 27, 2009