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

February 21, 2012 updated by: Sunovion

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

445

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Homewood, Alabama, United States, 35209
        • Alabama Asthma and Allergy Center
      • Mobile, Alabama, United States, 36607
        • MDC Research
    • California
      • Corona, California, United States, 92879
        • Integrated Research Group
      • Danville, California, United States, 94526
        • Allergy & Asthma Medical Group of Diablo Valley, Inc.
      • Encinitas, California, United States, 92024
        • Radiant Research, Inc.
      • Huntington Beach, California, United States, 92647
        • Allergy & Asthma Specialists Medical Group
      • Long Beach, California, United States, 90806
        • Allergy, Asthma & Respiratory Care Center
      • Los Angeles, California, United States, 90025
        • Allergy Research Foundation, Inc.
      • Orange, California, United States, 92868
        • Clinical Trials of Orange County
      • San Diego, California, United States, 92120
        • Allergy Associates Medical Group
      • San Diego, California, United States, 92123
        • Allergy & Asthma Medical Group & Research Center
      • San Diego, California, United States, 92131
        • Allergy & Asthma Prevention & Treatment Center
      • San Jose, California, United States, 95117
        • Allergy & Asthma Assoc. of Santa Clara Valley Research Center
      • Stockton, California, United States, 95207
        • Bensch Research Associates
      • Viejo, California, United States, 92691
        • Southern California Research Center
    • Colorado
      • Denver, Colorado, United States, 80206
        • National Jewish Medical & Research Center
      • Englewood, Colorado, United States, 80112
        • Clinical Research Centers of Colorado PC
      • Pueblo, Colorado, United States, 81001
        • Asthma & Allergy Associates, PC
    • Florida
      • Tallahassee, Florida, United States, 32308
        • Office of Ronald Saff
    • Georgia
      • Savannah, Georgia, United States, 31406
        • Aeroallergy Research Laboratories of Savannah, Inc.
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • Radiant Research Honolulu
    • Indiana
      • Indianapolis, Indiana, United States, 46208
        • Clinical Research Center of Indiana
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Allergy & Asthma Care Specialists
      • Slidell, Louisiana, United States, 70458
        • Northshore Medical Research
    • Maryland
      • Baltimore, Maryland, United States
        • University of Maryland School of Medicine
    • Massachusetts
      • N. Dartmouth, Massachusetts, United States, 02747
        • Northeast Medical Research Associates, Inc.
      • Needham, Massachusetts, United States, 02494
        • PCHI
      • Taunton, Massachusetts, United States, 02780
        • Center for Clinical Research
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
        • Clinical Research Institute
    • Mississippi
      • Jackson, Mississippi, United States
        • Mississippi Asthma & Allergy Clinic
    • Missouri
      • Columbia, Missouri, United States, 65212
        • Office of Clinical Research, University of Missouri-Columbia
      • Kansas City, Missouri, United States, 64108
        • The Children's Mercy Hospital
      • St. Louis, Missouri, United States, 63110
        • Division of Allergy & Immunology, Washington Univ School of Med
      • St. Louis, Missouri, United States, 63110
        • St. Louis University
      • St. Louis, Missouri, United States, 63141
        • The Clinical Research Center, LLC
    • New Jersey
      • Princeton, New Jersey, United States, 08540
        • Princeton Center For Clinical Research
      • Springfield, New Jersey, United States, 07081
        • Pulmonary and Allergy Associates
    • New York
      • Albany, New York, United States, 12205
        • PCCS
      • Rochester, New York, United States, 14618
        • AAIR Research Center
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Regional Allergy & Asthma Consultants
      • High Point, North Carolina, United States, 27262
        • Cornerstone Research Care
      • Raleigh, North Carolina, United States, 27609
        • Raleigh Pediatric Associates
    • Ohio
      • Cincinnati, Ohio, United States, 45231
        • Bernstein Clinical Research Center, LLC
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Allergy & Asthma Research
      • Portland, Oregon, United States, 97213
        • Allergy Associates Research Center, LLC
    • Pennsylvania
      • Chester, Pennsylvania, United States, 19013
        • Asthma & Allergy Research Associates
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital
      • Pittsburgh, Pennsylvania, United States, 15213
        • Children's Hospital of Pittsburgh Division of Allergy, Immunology & Infectious Diseases
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Division of Pulmonary
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Radiant Research
      • Greenville, South Carolina, United States, 29607
        • Office of Neil Kao
      • Mt. Pleasant, South Carolina, United States, 29464
        • Allergy & Asthma Consultants, LLP
    • Texas
      • Amarillo, Texas, United States, 79106
        • Office of Constantine Saadeh
      • Dallas, Texas, United States, 75231
        • Allergy & Asthma Research Associates
      • Fort Worth, Texas, United States, 76132
        • North Texas Institute for Clinical Trials
      • Houston, Texas, United States, 77054
        • Breath of Life Research Institute
      • San Antonio, Texas, United States
        • Lung Diagnostics
      • Waco, Texas, United States
        • Allergy & Asthma Center
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Children's Hospital of the Kings Daughters
      • Richmond, Virginia, United States, 23225
        • Pulmonary Associates of Richmond, Inc.
    • Washington
      • Seattle, Washington, United States, 98105
        • ASTHMA, Inc.
    • Wisconsin
      • West Allis, Wisconsin, United States, 53227
        • Allergic Diseases, SC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
levalbuterol MDI 90 mcg QID
Drug: levalbuterol tartrate MDI
levalbuterol 90 mcg QID
Other Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
percent change in FEV1 from visit predose averaged over the 8-week double-blind period
Time Frame: Weeks 0, 4, 8
Weeks 0, 4, 8

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Weeks 0, 4, 8
peak percent change in FEV1 from study baseline
Time Frame: Weeks 0, 4, 8
Weeks 0, 4, 8
peak change in FEV1 from visit predose
Time Frame: Weeks 0, 4, 8
Weeks 0, 4, 8
peak percent of predicted FEV1
Time Frame: Weeks 0, 4, 8
Weeks 0, 4, 8
area under the FEV1 curve (AUC)
Time Frame: Weeks 0, 4, 8
Weeks 0, 4, 8
peak change and peak percent change in FEF25-75% from visit predose
Time Frame: Weeks 0, 4, 8
Weeks 0, 4, 8
peak change and peak percent change in FVC from visit predose
Time Frame: Weeks 0, 4, 8
Weeks 0, 4, 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunovion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2002

Primary Completion (Actual)

January 1, 2003

Study Completion (Actual)

January 1, 2003

Study Registration Dates

First Submitted

December 9, 2003

First Submitted That Met QC Criteria

December 10, 2003

First Posted (Estimate)

December 11, 2003

Study Record Updates

Last Update Posted (Estimate)

February 22, 2012

Last Update Submitted That Met QC Criteria

February 21, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 051-353

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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