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

Sponsor:	Sepracor, Inc.
Information provided by:	Sepracor, Inc.
ClinicalTrials.gov Identifier:	NCT00064389

Purpose

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.

Condition	Intervention	Phase
Asthma	Drug: levalbuterol tartrate HFA MDI Drug: racemic albuterol	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Official Title:	Long Term Safety Study of Levalbuterol and Racemic Albuterol 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 hydrochloride Albuterol sulfate Levalbuterol tartrate

U.S. FDA Resources

Further study details as provided by Sepracor, Inc.:

Primary Outcome Measures:

incidence of post-randomization adverse events [ Time Frame: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

rate of discontinuations due to adverse events [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
time-to-selected adverse events (AEs with an incidence ≥5%) [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
asthma attacks, asthma adverse events, and expanded-definition asthma events [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
clinical laboratory values [ Time Frame: Weeks -1, 0, 10, 11, 26, 27, 43, 44, 52, 53 ] [ Designated as safety issue: No ]
vital signs (blood pressure, heart rate, respiration rate, and body temperature) [ Time Frame: Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 26, 27, 34, 35, 43, 44, 52, 53 ] [ Designated as safety issue: No ]
ECG parameters [ Time Frame: Weeks -1, 0, 1, 10, 11, 26, 27, 43, 44, 52, 53 ] [ Designated as safety issue: Yes ]
physical examinations [ Time Frame: Weeks -1, 0, 26, 27, 52, 53 ] [ Designated as safety issue: No ]
rescue medication, and daytime asthma control days [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
FEV1, FVC, FEF25-75%, peak expiratory flow [ Time Frame: Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 26, 27, 34, 35, 43, 44, 52, 53 ] [ Designated as safety issue: No ]
Asthma Quality of Life Questionnaire (AQLQ) [ Time Frame: Weeks 0, 26, 27, 52, 53 ] [ Designated as safety issue: No ]
subject and physician global evaluations [ Time Frame: Weeks 26, 27, 52, 53 ] [ Designated as safety issue: No ]
(S) and (R) albuterol plasma concentrations [ Time Frame: Weeks -1, 0, 10, 11, 26, 27, 43, 44, 52, 53 ] [ Designated as safety issue: No ]
subject assessment of study inhaler device performance [ Time Frame: 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 ] [ Designated as safety issue: No ]

Enrollment:	746
Study Start Date:	January 2003
Study Completion Date:	July 2005
Primary Completion Date:	July 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental levalbuterol 90 mcg MDI QID	Drug: levalbuterol tartrate HFA MDI levalbuterol MDI 90 mcg QID
2: Active Comparator racemic albuterol HFA MDI 180 mcg QID	Drug: racemic albuterol racemic albuterol HFA MDI 180 mcg QID

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.

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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00064389

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Locations

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

Sponsors and Collaborators

Sepracor, Inc.

Responsible Party:	Sepracor Inc. ( Xopenex Medical Director )
Study ID Numbers:	051-356
Study First Received:	July 8, 2003
Last Updated:	June 6, 2008
ClinicalTrials.gov Identifier:	NCT00064389 History of Changes
Health Authority:	United States: Food and Drug Administration