Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older With Asthma - Full Text View

Purpose

The primary purpose of this study was to investigate the efficacy of levalbuterol compared to a placebo and compared to albuterol in the treatment and prevention of bronchoconstriction in adolescent and adult subjects with asthma, with all treatments administered 4 times a day (QID).

Condition	Intervention	Phase
Asthma	Drug: levalbuterol tartrate MDI Drug: racemic albuterol MDI Drug: Placebo	Phase 3

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 and Safety Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older With Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma

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

U.S. FDA Resources

Further study details as provided by Sunovion:

Primary Outcome Measures:

percent change in FEV1 from visit predose averaged over the 8-week double-blind period [ Time Frame: Weeks 0, 4, 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

area under the FEV1 percent change curve from visit pre-dose and from study baseline curves averaged over the double-blind period [ Time Frame: Weeks 0, 4, 8 ] [ Designated as safety issue: No ]
peak percent change in FEV1 from study baseline [ Time Frame: Weeks 0, 4, 8 ] [ Designated as safety issue: No ]
peak change in FEV1 from visit predose [ Time Frame: Weeks 0, 4, 8 ] [ Designated as safety issue: No ]
peak percent of predicted FEV1 [ Time Frame: Weeks 0, 4, 8 ] [ Designated as safety issue: No ]
area under the FEV1 curve (AUC) [ Time Frame: Weeks 0, 4, 8 ] [ Designated as safety issue: No ]
peak change and peak percent change in FEF25-75% from visit predose [ Time Frame: Weeks 0, 4, 8 ] [ Designated as safety issue: No ]
peak change and peak percent change in FVC from visit predose [ Time Frame: Weeks 0, 4, 8 ] [ Designated as safety issue: No ]

Enrollment:	445
Study Start Date:	May 2002
Study Completion Date:	January 2003
Primary Completion Date:	January 2003 (Final data collection date for primary outcome measure)

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

Detailed Description:

This was a Phase III, multicenter, randomized, double-blind, placebo- and active-controlled, parallel-group study of up to 9 weeks in duration. Seven days of QID single-blind placebo administration (via MDI) was followed by 56 days of QID double-blind active treatment. Following the run-in period, each subject was randomized to one of the following three treatments: levalbuterol HFA MDI 90 mcg (2 actuations of 45 mcg), racemic albuterol HFA MDI 180 mcg (2 actuations of 90 mcg), or placebo (2 actuations). Subjects were randomized in a 2:1:1 ratio of levalbuterol to racemic albuterol to placebo. In order to maintain blinding of the device, a placebo dose was administered with each treatment. 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:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Willing and able to comply with the study procedures and visit schedules
Male or female, at least 12 years of age
Female subjects 12-60 years of age must have a negative serum pregnancy test at study start.
Women of child bearing potential must be using an acceptable method of birth control
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 OTC asthma medication for at least 6 months prior to study start
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
Must have a chest X-ray that is not diagnostic of pneumonia, atelectasis, pulmonary fibrotic disease, pneumothorax, chronic obstructive pulmonary disease, etc.
Must be able to complete the diary cards and medical event calendars reliably on a daily basis, understand dosing instructions, 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
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
Have a history of hospitalization for asthma within 45 days prior to study start, or who is scheduled for in-patient hospitalization, including elective surgery
Have a known sensitivity to levalbuterol or racemic albuterol, or any excipients in any of these formulations
Subject using any prescription drug with which albuterol sulfate administration is contraindicated
Subject with currently diagnosed life-threatening asthma
History of cancer (exception: basal cell carcinoma in remission).
Subject with hyperthyroidism, diabetes, hypertension, cardiac diseases or seizure disorders that currently are not well controlled by medication
History of substance abuse or drug abuse within 12 months preceding study start
Subject with greater than 10 pack year history of cigarette smoking or use of any tobacco products within 6 months of study start
Documented history of bronchopulmonary aspergillosis or any form of allergic alveolitis
Have suffered from a clinically significant upper or lower respiratory tract infection in the 2 weeks prior to study start
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: NCT00073827

Show 63 Study Locations

Sponsors and Collaborators

Sunovion

More Information

No publications provided

Responsible Party:	Sunovion
ClinicalTrials.gov Identifier:	NCT00073827 History of Changes
Other Study ID Numbers:	051-353
Study First Received:	December 9, 2003
Last Updated:	February 21, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sunovion:

adolescent
adult
asthma
levalbuterol
bronchoconstriction

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 May 16, 2013