Long Term Safety Study of Levalbuterol and Racemic Albuterol in Subjects Twelve Years of Age and Older With Asthma

The purpose of this study is to evaluate the safety of levalbuterol as compared to racemic albuterol based on the frequencies of adverse events reporting during a 12-month period of chronic dosing of adolescent and adult subjects with asthma.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: levalbuterol tartrate HFA MDI; Drug: racemic albuterol

Detailed Description

This was a randomized, open-label, active controlled, multicenter, parallel-group safety study in subjects 12 years of age and older with asthma. Subjects of appropriate age who completed the Phase III levalbuterol HFA MDI trials (Studies 051-353 or 051-355) were eligible to participate. Studies 051-353 and 051-355, both entitled "An Efficacy and Safety Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older with Asthma" were multicenter, randomized, double-blind, placebo- and active-controlled, parallel-group studies of up to nine weeks in duration (a one-week single-blind placebo run in period followed by an eight-week double-blind treatment period). Subjects who completed Studies 051 353 and 051 355 but who were not immediately eligible to rollover into the current study could also participate but only after a 30-day washout. New subjects and subjects who participated in the Phase III trials who were not immediately eligible (ie, had a >30-day washout) were considered to be de novo subjects.Study participation included 10 study visits over a 12 month period.

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): 746
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5K 1Z9
      • Trial Management Group
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2H 2A6
      • St. Boniface General Hospital
  • Ontario
    • Mississauga, Ontario, Canada, L5B 1N1
      • Clinical Research Group
    • Niagara Falls, Ontario, Canada, L2E 7H1
      • Niagara Clinical Research, Inc.
    • Toronto, Ontario, Canada, M6H 3M2
      • Primary Care Lung Clinic
• United States
  • Alabama
    • Birmington, Alabama, United States, 35233
      • Jefferson Clinic PC
    • Mobile, Alabama, United States, 36608
      • Pulmonary Associates Research Division
    • Montgomery, Alabama, United States, 36111
      • Montgomery Pulmonary Consultants
    • Oxford, Alabama, United States, 36203
      • Center of Research Excellence, LLC
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Lovelace Scientific Resources
    • Tucson, Arizona, United States, 85745
      • Alta Clinical Research, LLC
  • California
    • Corona, California, United States, 92506
      • Integrated Research Group
    • Fair Oaks, California, United States, 95628
      • Northern California Research Corp
    • Long Beach, California, United States, 90806
      • Allergy, Asthma & Respiratory Care Center
    • Madera, California, United States, 93637
      • Madera Family Medical Group
    • Orange, California, United States, 92868
      • Clinical Trials of Orange County, Inc.
    • San Diego, California, United States, 92120
      • Institute of HealthCare Assessment, Inc.
    • Westlake Village, California, United States, 91361
      • Westlake Medical Research, Inc.
  • Colorado
    • Denver, Colorado, United States, 80209
      • Office of Constantine Falliers, MD
  • Florida
    • Ft. Lauderdale, Florida, United States, 33316
      • Office of Gary Richmond, MD
    • Ft. Myers, Florida, United States, 33907
      • CNS Clinical Trials
    • Kissimmee, Florida, United States, 34741
      • FPA Clinical Research
    • Longwood, Florida, United States, 32750
      • Orlando Clinic for Asthma & Respiratory Diseases
    • Miami, Florida, United States, 33173
      • Allergy Sinus Asthma Research Institute
    • Miami, Florida, United States, 33176
      • Florida Center for Alergy & Asthma Research
    • Orlando, Florida, United States, 32806
      • Orlando Clinical Research Center
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Family Allergy & Asthma Center, PC
    • Conyers, Georgia, United States, 30013
      • The Allergy & Asthma Clinic Research Center
    • Savannah, Georgia, United States, 31046
      • Aeroallergy Research
  • Illinois
    • Bloomington, Illinois, United States, 61761
      • Sneeze, Wheeze and Itch, LLC
    • Chicago, Illinois, United States, 60612
      • Rush Presbyterian - St. Luke's Medical Center
    • Glenview, Illinois, United States, 60025
      • Children's Asthma Respiratory & Exercise Specialists
    • Springfield, Illinois, United States
      • Cardinal Respiratory, PC
  • Indiana
    • Indianapolis, Indiana, United States, 46208
      • Clinical Research Center of Indiana
    • South Bend, Indiana, United States, 46617
      • South Bend Clinic
  • Kansas
    • Olathe, Kansas, United States, 66061
      • Consultants in Pulmonary Medicine
    • Wichita, Kansas, United States, 67207
      • Heartland Research Associates
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • Northshore Medical Research
  • Maryland
    • Wheaton, Maryland, United States
      • Institute for Asthma & Allergy, PC
  • Massachusetts
    • Taunton, Massachusetts, United States, 02780
      • Center for Clinical Research
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital & Medical Centers
    • Flint, Michigan, United States, 45832
      • Hurley Child and Adolescent Asthma Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55402
      • Clinical Research Institute
  • Missouri
    • Jefferson City, Missouri, United States, 65101
      • Allergy, Asthma, Immunology Services, LLC
    • St. Charles, Missouri, United States, 63301
      • Midwest Chest Consultants, PC
    • St. Louis, Missouri, United States, 63110
      • Washington University School of Medicine, Division of Allergy & Immunology
  • Montana
    • Missoula, Montana, United States, 59804
      • Montana Medical Research, LLC
  • Nebraska
    • Lincoln, Nebraska, United States, 68505
      • Allergy, Asthma & Immunology Associates, PC
    • Omaha, Nebraska, United States, 68134
      • Heartland Clinical Research Inc.
    • Omaha, Nebraska, United States, 68144
      • Office of Meera Dewan, MD
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08003
      • Delaware Valley Institute for Clinical Research
    • Tinton Falls, New Jersey, United States, 07701
      • Clinical Research Center of Allergy & Asthma Consultants
  • New Mexico
    • Albuquerque, New Mexico, United States, 87108
      • Lovelace Scientific Resources
    • Los Alamos, New Mexico, United States, 87544
      • Allergy & Asthma of Northern NM
  • New York
    • Bay Shore, New York, United States, 11706
      • Pulmonary Medical Research of NY
    • Cortland, New York, United States, 13045
      • Asthma & Allergy Associates, PC
    • Staten Island, New York, United States, 10304
      • Office of Michael Marcus, MD
    • Tonawanda, New York, United States, 14150
      • Office of Richard Castaldo
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Regional Allergy & Asthma Consultants
    • Charlotte, North Carolina, United States, 28207
      • Charlotte Lung & Health Center
    • Charlotte, North Carolina, United States, 28262
      • Neem Research Group, Inc.
    • High Point, North Carolina, United States
      • Cornerstone Research Care
    • Winston-Salem, North Carolina, United States, 27103
      • Carolina MedTrials, LLC
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Allergy & Asthma Care Center
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Sterling Research Group
    • Cincinnati, Ohio, United States, 45241
      • New Horizons Clinical Research
    • Columbus, Ohio, United States, 43235
      • Optimed Research LLC
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Allergy, Asthma & Clinical Research Center
  • Oregon
    • Lake Oswego, Oregon, United States, 97035
      • Allergy, Asthma and Dermatology Research Center
    • Medford, Oregon, United States, 97504
      • Medford Medical Clinic, LLP
  • Pennsylvania
    • Bellevue, Pennsylvania, United States, 15202
      • Bellevue Pediatric Associates
    • Easton, Pennsylvania, United States, 18045
      • Valley Clinical Research Center
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Hospital
    • Philadelphia, Pennsylvania, United States, 19115
      • Allergy & Asthma Research of NJ, Inc.
    • Shillington, Pennsylvania, United States, 19607
      • Advanced Clinical Concepts
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Neem Research Group of Charleston
    • Columbia, South Carolina, United States, 29201
      • Neem Research Group Inc.
    • Greenville, South Carolina, United States, 29607
      • Allergic Disease & Asthma Center, PA
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • Asthma Institute
    • Knoxville, Tennessee, United States, 37917
      • The Allergy Associates
  • Texas
    • Amarillo, Texas, United States, 79106
      • Office of Constantine Saadeh
    • Austin, Texas, United States, 78749
      • Allergy & Asthma Clinical of Central Texas
    • Galveston, Texas, United States, 00000
      • UTX Medical
    • Houston, Texas, United States, 77054
      • Breath of Life Research Institute
    • Houston, Texas, United States, 77070
      • Clinical Trials of North Houston
    • Houston, Texas, United States, 77024
      • Breco Research
    • New Braunfels, Texas, United States, 78130
      • Central Texas Health Research
    • San Antonio, Texas, United States, 78229
      • Lung Diagnostics
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Hampton Roads Center for Clinical Research
    • Richmond, Virginia, United States, 23225
      • Pulmonary Associates of Richmond Inc.
    • Richmond, Virginia, United States, 23294
      • National Clinical Research
    • Richmond, Virginia, United States, 23229
      • Virginia Adult & Pediatric Allergy & Asthma PC
  • Washington
    • Spokane, Washington, United States, 99204
      • The Physician's Clinic of Spokane
  • Wisconsin
    • Greenfield, Wisconsin, United States, 53228
      • Allergy, Asthma, and Sinus Center F.C.
    • Milwaukee, Wisconsin, United States, 53209
      • Milwaukee Medical Clinic
    • West Allis, Wisconsin, United States, 53227
      • Allergic Diseases, S.C.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

• Willing and able to comply with study procedures and visit schedules
• Females 12-60 yrs must have a negative serum pregnancy test at study start
• Women of child bearing potential must use acceptable method of birth control throughout study
• Confirmed diagnosis of asthma minimum of 6 mos. prior to study start
• Have stable baseline asthma and have been using B-adrenergic agonist, and/or anti-asthma anti-inflammatory meds, and/or OTC asthma meds. >6 mos. prior to study start
• In good health with exception of reversible airways disease and not suffering from any chronic condition that might affect their respiratory function
• Had chest X-ray w/in 12 mos. prior to randomization that is not diagnostic of pneumonia, atelectasis, pulmonary fibrotic disease, pneumothorax, chronic obstructive pulmonary disease etc.
• Subject rolling over from either Sepracor study 051-353 or 051-355 must have successfully completed the study
• Subject who is not immediately rolled over from Sepracor study 051-353 or 051-355 must wait >30 days and will be regarded as a de novo subject
• Able to complete daily diary cards and medical event calendars reliably, understand dosing instructions, demonstrate how to use the MiniWright PEF meter. Minor subjects must have a parent/legal guardian assist them during the study with these activities

Exclusion Criteria

• Female who is pregnant or lactating
• Participated in investigational drug study w/in 30 days prior to study start, or currently participating in another clinical trial, other than Sepracor studies 051-353 or 051-355
• Subject who early terminated from Sepracor study 051-353 or 051-355
• Subject whose schedule prevents him or her from taking the first daily dose of study medication and/or starting study visits before 10 AM
• Have travel commitments during the study that would interfere with trial measurements and/or compliance
• History of hospitalization for asthma w/in 45 days prior to study start, or scheduled for in-patient hospitalization, including elective surgery during 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 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 or may interfere with the successful completion of this protocol
• History of substance abuse or drug abuse within 12 months preceding V1
• Subject with >10 pack/yr 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

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1; levalbuterol 90 mcg MDI QID	Drug: levalbuterol tartrate HFA MDI; levalbuterol MDI 90 mcg QID; Other Names: Xopenex HFA MDI
ACTIVE_COMPARATOR: 2; racemic albuterol HFA MDI 180 mcg QID	Drug: racemic albuterol; racemic albuterol HFA MDI 180 mcg QID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
incidence of post-randomization adverse events	Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53

Secondary Outcome Measures

Outcome Measure	Time Frame
rate of discontinuations due to adverse events	Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53
time-to-selected adverse events (AEs with an incidence ≥5%)	Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53
asthma attacks, asthma adverse events, and expanded-definition asthma events	Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53
clinical laboratory values	Weeks -1, 0, 10, 11, 26, 27, 43, 44, 52, 53
vital signs (blood pressure, heart rate, respiration rate, and body temperature)	Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 26, 27, 34, 35, 43, 44, 52, 53
ECG parameters	Weeks -1, 0, 1, 10, 11, 26, 27, 43, 44, 52, 53
physical examinations	Weeks -1, 0, 26, 27, 52, 53
rescue medication, and daytime asthma control days	Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53
FEV1, FVC, FEF25-75%, peak expiratory flow	Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 26, 27, 34, 35, 43, 44, 52, 53
Asthma Quality of Life Questionnaire (AQLQ)	Weeks 0, 26, 27, 52, 53
subject and physician global evaluations	Weeks 26, 27, 52, 53
(S) and (R) albuterol plasma concentrations	Weeks -1, 0, 10, 11, 26, 27, 43, 44, 52, 53
subject assessment of study inhaler device performance	Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53

Collaborators and Investigators

• Sponsor: Sunovion

Study record dates

Study Major Dates

• Study Start: January 1, 2003
• Primary Completion (ACTUAL): July 1, 2005
• Study Completion (ACTUAL): July 1, 2005

Study Registration Dates

• First Submitted: July 8, 2003
• First Submitted That Met QC Criteria: July 8, 2003
• First Posted (ESTIMATE): July 9, 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

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Reproductive Control Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Albuterol
• Other Study ID Numbers: 051-356