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 objective of this study is to investigate the efficacy of levalbuterol 90 ug (2 actuations, 45 ug each) versus placebo (2 actuations) 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

A double-blind, randomized, placebo- and active-controlled, multicenter, parallel-group trial of levalbuterol in subjects 12 years of age and older with asthma. Study participation will include one 1-week single-blind placebo run-in and an 8-week, randomized,double-blind, active-treatment period with four treatment groups. 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)

386

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
      • Oxford, Alabama, United States, 36203
        • Allergy & Asthma Center, LLC
    • Arizona
      • Tucson, Arizona, United States, 85745
        • Alta Clinical Research
    • California
      • Corona, California, United States, 92879
        • Integrated Research Group
      • Encinitas, California, United States, 92024
        • Radiant Research, Inc.
      • Huntington Beach, California, United States, 92647
        • Allergy & Asthma Specialists Medical Group
      • Long Beach, California, United States, 90808
        • Asthma, Allergy & Respiratory Care Center
      • Los Angeles, California, United States, 90025
        • Allergy Research Foundation, Inc.
      • Madera, California, United States, 93637
        • Madera Family Medical Group
      • Mission Viejo, California, United States, 92691
        • Southern California Research
      • Oakland, California, United States, 94609
        • Comprehensive Allergy Services
      • 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 Jose, California, United States, 95117
        • Allergy & Asthma Assoc. of Santa Clara Valley Research Center
      • Signal Hill, California, United States, 90755
        • West Coast Clinical Trials
      • Walnut Creek, California, United States, 94598
        • Allergy & Asthma Medical Group of Diablo Valley, Inc.
    • Colorado
      • Thornton, Colorado, United States, 80233
        • 1st Allergy & Asthma Clinical Research Ctr
    • Georgia
      • Barnesville, Georgia, United States, 30204
        • Watts Medical Research
      • Conyers, Georgia, United States, 30013
        • The Allergy & Asthma Clinical Research Center
      • Savannah, Georgia, United States, 31406
        • AeroAllergy Research Laboratories of Savannah, Inc.
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush Presbyterian - St. Luke's Medical Center Rush University
    • Indiana
      • South Bend, Indiana, United States, 46617
        • South Bend Clniic
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Clinical Research Specialist
      • New Orleans, Louisiana, United States, 70122
        • Doctor's Care
      • Slidell, Louisiana, United States, 70458
        • Children's International Medical Research
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
        • Clinical Research Institute
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • The Clinical Research Center, LLC
    • Nebraska
      • Omaha, Nebraska, United States, 68134
        • Heartland Clinical Research Inc.
      • Papillion, Nebraska, United States, 68046
        • Asthma & Allergy Center PC
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Office of Yekaterina Khronusova, MD
    • New York
      • Bay Shore, New York, United States, 11706
        • Pulmonary Medical Research of NY, PLLC
      • Cortland, New York, United States, 13046
        • Asthma & Allergy Associates PC
      • Rochester, New York, United States, 14618
        • AAIR Research Center
      • Tonawanda, New York, United States, 14150
        • Office or Richard Castaldo, MD
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Charlotte Lung and Health Center
      • Elizabeth City, North Carolina, United States, 27909
        • Albermarle Allergy & Asthma PC
      • Winston-Salem, North Carolina, United States, 27103
        • Piedmont Medical Research
    • Ohio
      • Cincinnati, Ohio, United States, 45241
        • New Horizons Clinical Research, Inc.
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Allergy, Asthma & Clinical Research Center
    • Oregon
      • Portland, Oregon, United States, 97213
        • Allergy Associates Research Center, LLC
    • Pennsylvania
      • Easton, Pennsylvania, United States, 18045
        • Valley Clinical Research Center
      • Temple, Pennsylvania, United States, 19560
        • Advanced Clinical Concepts
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Allergic Disease & Asthma Center PA
      • Mt. Pleasant, South Carolina, United States, 29464
        • Allergy & Asthma Consultants, LLP
    • Texas
      • Austin, Texas, United States, 78749
        • Allergy and Asthma Clinic of Central Texas
      • Dallas, Texas, United States, 75234
        • Research Across America
      • Houston, Texas, United States, 77024
        • Breco Research
      • Houston, Texas, United States, 77084
        • Breath of Life Research Institute
      • San Antonio, Texas, United States, 78229
        • Lung Diagnostics
    • Virginia
      • Burke, Virginia, United States, 22015
        • PI - Coor Clinical Research, LLC
      • Richmond, Virginia, United States, 23225
        • Pulmonary Associates of Richmond, Inc.
    • Washington
      • Spokane, Washington, United States, 99220
        • Rockwood Clinics, PS
    • Wisconsin
      • Greenfield, Wisconsin, United States, 53228
        • Allergy, Asthma and Sinus Center F.C.
      • 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

  • Must give written informed consent (IC) prior to participation in the study. For subjects 12 - 17 years of age, the IC must be signed parent or legal guardian. Females must sign the Women of Childbearing Potential Addendum
  • Be willing and able to comply with the study procedures and visit schedules
  • Male or female, at least 12 years of age
  • Females 12-60 years of age must have a negative serum pregnancy test at Visit 1 (V1)
  • Women of child bearing potential must be using an acceptable method of birth control
  • Must have a documented diagnosis of asthma for a min. of 6 mos. prior to V1
  • At V1, the subject must demonstrate a baseline FEV1 within >45% and <75% of predicted for their height, age, gender, and race
  • Following abstention from medications used to treat asthma, subject must demonstrate >12% reversibility of airflow obstruction within 15-30 min. following inhalation of 180 µg (2 actuations, 90 µg ea.) of racemic albuterol MDI
  • 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 mos. prior to V1
  • 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 and demonstrate how to use the MiniWright PEF meter

Exclusion Criteria

  • Subject who is expected to require any disallowed medications
  • Female subject who is pregnant or lactating
  • Subject who has participated in an investigational drug study within 30 days prior to V1, 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 9AM
  • 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 45 days prior to V1, or who is scheduled for in-patient hospitalization during 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
  • Subject with currently diagnosed life-threatening asthma
  • Subject with clinically significant abnormalities that may interfere with the metabolism or excretion of the study drug
  • Have a history of cancer (exception: basal cell carcinoma in remission)
  • Have hyperthyroidism, diabetes, hypertension, cardiac diseases, or seizure disorders not well controlled by medication or that may interfere with the successful completion of this protocol
  • Have a history of substance or drug abuse within 12 mos. preceding V1 or a positive urine drug screening at V1
  • Have greater than 10 pack year history of cigarette smoking or use of any tobacco products within 6 mos. of V1
  • Have a 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 V1
  • Have any clinically significant abnormal laboratory values
  • Have a clinically significant abnormal 12-lead ECG that may jeopardize the subject's ability to complete study
  • 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
Active Comparator: I
Levalbuterol 90 ųg QID (manufacturing site A or B)
Drug: levalbuterol
  • Levalbuterol 90 ųg QID (manufacturing sites A or B);
  • Racemic Albuterol 180 ųg QID;
  • Placebo QID
Other Names:
  • Xopenex HFA (levalbuterol tartrate)Inhalation Aerosol
Active Comparator: II
Racemic Albuterol 180 ųg QID
Drug: levalbuterol
  • Levalbuterol 90 ųg QID (manufacturing sites A or B);
  • Racemic Albuterol 180 ųg QID;
  • Placebo QID
Other Names:
  • Xopenex HFA (levalbuterol tartrate)Inhalation Aerosol
Placebo Comparator: III
Placebo QID
Drug: levalbuterol
  • Levalbuterol 90 ųg QID (manufacturing sites A or B);
  • Racemic Albuterol 180 ųg QID;
  • Placebo QID
Other Names:
  • Xopenex HFA (levalbuterol tartrate)Inhalation Aerosol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
FEV1 (peak percent change from pre-dose averaged over the double-blind period).
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
--FEV1 [area under the % change from pre-dose FEV1 curve] and FEV1 [area under the % change from study baseline FEV1 curve]
Time Frame: 9 weeks
9 weeks

Collaborators and Investigators

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

Sponsor

Sunovion

Investigators

  • Study Chair: John Hanrahan, M.D., Sunovion

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

December 1, 2002

Primary Completion (Actual)

June 1, 2003

Study Completion (Actual)

June 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

  • 051-355

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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