Safety and Tolerability Study of Levalbuterol HFA and Racemic Albuterol HFA in Pediatrics Subjects With Asthma - Full Text View

Sponsor:	Sunovion
Information provided by:	Sunovion
ClinicalTrials.gov Identifier:	NCT00684866

Purpose

The purpose of this study is to compare the safety and tolerability of levalbuterol HFA metered dose inhaler (MDI) versus racemic albuterol HFA MDI in pediatric subjects 4-11 years of age with asthma

Condition	Intervention	Phase
Asthma	Drug: Levalbuterol HFA MDI followed by Racemic albuterol HFA MDI Drug: Racemic Albuterol followed by levalbuterol HFA MDI	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Cumulative Dose Tolerability Study of Levalbuterol HFA and Racemic Albuterol HFA in Pediatric Subjects With Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma Potassium

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:

Increases from visit pre-dose to each post-dose dose measurement in heart rate, blood pressure (systolic and diastolic), potassium and glucose [ Time Frame: 0, 7, 10 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Percent change in FEV1 (from visit pre-dose to each post dose measure) [ Time Frame: Days 0, 7, 10 ] [ Designated as safety issue: No ]
Percent change in FVC (from visit pre-dose to each post dose measure) [ Time Frame: Days 0, 7, 10 ] [ Designated as safety issue: No ]
Percent change in FEF25-75% (from visit pre-dose to each post dose measure) [ Time Frame: Days 0, 7, 10 ] [ Designated as safety issue: No ]
Number of cumulative actuations received [ Time Frame: Days 0, 7, 10 ] [ Designated as safety issue: No ]

Enrollment:	31
Study Start Date:	January 2003
Study Completion Date:	July 2003
Primary Completion Date:	July 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A Subjects will receive both treatments: (a) levalbuterol HFA MDI; 45 micrograms (8 cumulative doses); followed by (b) racemic albuterol HFA MDI; 90 micrograms (8 cumulative doses). The first treatment will be administered, followed by a 7 ±2 days washout period, after which the second of the two treatments will be administered. Cumulative dosing will occur according to the following schedule: 1 puff at 0 and 30 minutes, 2 puffs at 60 minutes, 4 puffs at 90 minutes and 8 puffs at 120 minutes. Treatment will be administered with an AeroChamber Plus ™ spacer for the first cohort (spacer cohort) of subjects and without the AeroChamber Plus ™ spacer (non-spacer cohort) for the second cohort of subjects.	Drug: Levalbuterol HFA MDI followed by Racemic albuterol HFA MDI (a) Subjects will receive both treatments: (a) levalbuterol HFA MDI; 45 micrograms (16 cumulative doses); followed by (b) racemic albuterol HFA MDI; 90 micrograms (16 cumulative doses) Other Names: Xopenex HFA MDI albuterol HFA MDI
Active Comparator: B Subjects will receive both treatments: (a) racemic albuterol HFA MDI; 90 micrograms (16 cumulative doses) followed by (b) levalbuterol HFA MDI; 45 micrograms (16 cumulative doses) The first treatment will be administered, followed by a 7 ±2 days washout period, after which the second of the two treatments will be administered. Cumulative dosing will occur according to the following schedule: 1 puff at 0 and 30 minutes, 2 puffs at 60 minutes, 4 puffs at 90 minutes and 8 puffs at 120 minutes. Treatment will be administered with an AeroChamber Plus ™ spacer for the first cohort (spacer cohort) of subjects and without the AeroChamber Plus ™ spacer (non-spacer cohort) for the second cohort of subjects.	Drug: Racemic Albuterol followed by levalbuterol HFA MDI (a) Subjects will receive both treatments: (a) racemic albuterol HFA MDI; 90 micrograms (16 cumulative doses) followed by (b) levalbuterol HFA MDI; 45 micrograms (16 cumulative doses) Other Names: albuterol HFA MDI Xopenex HFA MDI

Arms

Assigned Interventions

Experimental: A

Subjects will receive both treatments: (a) levalbuterol HFA MDI; 45 micrograms (8 cumulative doses); followed by (b) racemic albuterol HFA MDI; 90 micrograms (8 cumulative doses).

The first treatment will be administered, followed by a 7 ±2 days washout period, after which the second of the two treatments will be administered. Cumulative dosing will occur according to the following schedule: 1 puff at 0 and 30 minutes, 2 puffs at 60 minutes, 4 puffs at 90 minutes and 8 puffs at 120 minutes. Treatment will be administered with an AeroChamber Plus ™ spacer for the first cohort (spacer cohort) of subjects and without the AeroChamber Plus ™ spacer (non-spacer cohort) for the second cohort of subjects.

Drug: Levalbuterol HFA MDI followed by Racemic albuterol HFA MDI

(a) Subjects will receive both treatments: (a) levalbuterol HFA MDI; 45 micrograms (16 cumulative doses); followed by (b) racemic albuterol HFA MDI; 90 micrograms (16 cumulative doses)

Other Names:

Xopenex HFA MDI
albuterol HFA MDI

Active Comparator: B

Subjects will receive both treatments: (a) racemic albuterol HFA MDI; 90 micrograms (16 cumulative doses) followed by (b) levalbuterol HFA MDI; 45 micrograms (16 cumulative doses) The first treatment will be administered, followed by a 7 ±2 days washout period, after which the second of the two treatments will be administered. Cumulative dosing will occur according to the following schedule: 1 puff at 0 and 30 minutes, 2 puffs at 60 minutes, 4 puffs at 90 minutes and 8 puffs at 120 minutes. Treatment will be administered with an AeroChamber Plus ™ spacer for the first cohort (spacer cohort) of subjects and without the AeroChamber Plus ™ spacer (non-spacer cohort) for the second cohort of subjects.

Drug: Racemic Albuterol followed by levalbuterol HFA MDI

(a) Subjects will receive both treatments: (a) racemic albuterol HFA MDI; 90 micrograms (16 cumulative doses) followed by (b) levalbuterol HFA MDI; 45 micrograms (16 cumulative doses)

Other Names:

albuterol HFA MDI
Xopenex HFA MDI

Detailed Description:

A randomized, double-blind, active-controlled multicenter, two-way crossover study of HFA levalbuterol (with and without a spacer) in subjects 4-11 years of age with asthma. 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, male or female, must be between the ages of 4 to 11 years, inclusive, at the time of consent.
Female subjects who are 8 years of age or older will have a negative serum pregnancy test at study start.
Subject must have a documented diagnosis of asthma for a minimum of 6 months prior to study start.
Subject must be in good health with the exception of their reversible airways disease and not suffering from any chronic condition that might affect their respiratory function.
Subject must have a chest X-ray or have one taken within 12 months prior to randomization may be used.
Subject's parent/legal guardian must be able to complete the diary cards and medical event calendars reliably on a daily basis and understand dosing instructions. Any subject who is not able to do this must have a parent/legal guardian who can assist them during the study with these activities.

Exclusion Criteria:

Female subject who is pregnant or lactating.
Subject who has participated in an investigational drug study within 30 days prior to study start, or who is currently participating in another clinical trial.
Subject whose schedule prevents him or her from taking the first daily dose of study medication and/or starting study visits before 9 AM.
Subject who has travel commitments during the study that would interfere with trial measurements or compliance or both.
Subject who has a history of hospitalization for asthma within 4 weeks prior to study start, or who is scheduled for in-patient hospitalization, including elective surgery during the course of the trial
Subject with 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.
Subject with currently diagnosed life-threatening asthma defined as a history of asthma episodes requiring intubation, associated with hypercapnia, respiratory arrest, or hypoxic seizures within 3 months prior to study start.
Subject with a history of cancer.
Subject with hyperthyroidism, diabetes, hypertension, cardiac diseases or seizure disorders.
Subject with a history of substance abuse or drug abuse within 12 months preceding study start.
Subject with a history of cigarette smoking or use of any tobacco products.
Subject with a documented history of bronchopulmonary aspergillosis or any form of allergic alveolitis.
Subject who has suffered from a clinically significant upper or lower respiratory tract infection in the 2 weeks prior to study start.
Subject with unstable asthma; or who have had a change in asthma therapy; or a visit to the Emergency Department or hospital for worsening asthma within 4 weeks.
Subject who is a staff member or relative of a staff member.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00684866

Locations

United States, California

Madera, California, United States

San Diego, California, United States
United States, Georgia

Savannah, Georgia, United States
United States, Kentucky

Louisville, Kentucky, United States
United States, New York

Cortland, New York, United States
United States, Oregon

Medford, Oregon, United States

Portland, Oregon, United States
United States, Pennsylvania

Chester, Pennsylvania, United States
United States, Tennessee

Knoxville, Tennessee, United States
United States, Texas

Dallas, Texas, United States

Houston, Texas, United States

Sponsors and Collaborators

Sunovion

More Information

No publications provided

Responsible Party:	Xopenex Medical Director, Sunovion Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:	NCT00684866 History of Changes
Other Study ID Numbers:	051-311
Study First Received:	May 23, 2008
Last Updated:	November 1, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sunovion:

Asthma
Levalbuterol
Racemic Albuterol

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