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

Sponsor:	Sunovion
Information provided by:	Sunovion
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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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 Sunovion:

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
Experimental: 1 levalbuterol MDI 90 mcg QID	Drug: Levalbuterol tartrate MDI levalbuterol MDI 90 mcg QID Other Name: Xopenex MDI
Active Comparator: 2 racemic albuterol MDI 190 mcg QID	Drug: racemic albuterol MDI racemic albuterol MDI 180 mcg QID
Placebo Comparator: 3 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. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

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

Show 45 Study Locations

Sponsors and Collaborators

Sunovion

More Information

No publications provided

Responsible Party:	Xopenex Medical Director, Sunovion Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:	NCT00073814 History of Changes
Other Study ID Numbers:	051-354
Study First Received:	December 9, 2003
Last Updated:	November 1, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sunovion:

levalbuterol
pediatric
asthma

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 09, 2012