Clinical trial NCT00064389: Long Term Safety Study of Levalbuterol and Racemic Albuterol in Subjects Twelve Years of Age and Older With Asthma
Official title: Long Term Safety Study of Levalbuterol and Racemic Albuterol in Subjects Twelve Years of Age and Older With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2003-07-09
Enrollment: 746
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility 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

Primary outcomes:
measure: incidence of post-randomization adverse events
timeFrame: 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 outcomes:
measure: rate of discontinuations due to adverse events
timeFrame: 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
measure: time-to-selected adverse events (AEs with an incidence ≥5%)
timeFrame: 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
measure: asthma attacks, asthma adverse events, and expanded-definition asthma events
timeFrame: 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
measure: clinical laboratory values
timeFrame: Weeks -1, 0, 10, 11, 26, 27, 43, 44, 52, 53
measure: vital signs (blood pressure, heart rate, respiration rate, and body temperature)
timeFrame: Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 26, 27, 34, 35, 43, 44, 52, 53
measure: ECG parameters
timeFrame: Weeks -1, 0, 1, 10, 11, 26, 27, 43, 44, 52, 53
measure: physical examinations
timeFrame: Weeks -1, 0, 26, 27, 52, 53
measure: rescue medication, and daytime asthma control days
timeFrame: 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
measure: FEV1, FVC, FEF25-75%, peak expiratory flow
timeFrame: Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 26, 27, 34, 35, 43, 44, 52, 53
measure: Asthma Quality of Life Questionnaire (AQLQ)
timeFrame: Weeks 0, 26, 27, 52, 53
measure: subject and physician global evaluations
timeFrame: Weeks 26, 27, 52, 53
measure: (S) and (R) albuterol plasma concentrations
timeFrame: Weeks -1, 0, 10, 11, 26, 27, 43, 44, 52, 53
measure: subject assessment of study inhaler device performance
timeFrame: 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
Other outcomes:
Locations:
city: Birmington
country: United States
facility: Jefferson Clinic PC
state: Alabama
city: Mobile
country: United States
facility: Pulmonary Associates Research Division
state: Alabama
city: Montgomery
country: United States
facility: Montgomery Pulmonary Consultants
state: Alabama
city: Oxford
country: United States
facility: Center of Research Excellence, LLC
state: Alabama
city: Phoenix
country: United States
facility: Lovelace Scientific Resources
state: Arizona
city: Tucson
country: United States
facility: Alta Clinical Research, LLC
state: Arizona
city: Corona
country: United States
facility: Integrated Research Group
state: California
city: Fair Oaks
country: United States
facility: Northern California Research Corp
state: California
city: Long Beach
country: United States
facility: Allergy, Asthma & Respiratory Care Center
state: California
city: Madera
country: United States
facility: Madera Family Medical Group
state: California
city: Orange
country: United States
facility: Clinical Trials of Orange County, Inc.
state: California
city: San Diego
country: United States
facility: Institute of Healthcare Assessment, Inc.
state: California
city: Westlake Village
country: United States
facility: Westlake Medical Research, Inc.
state: California
city: Denver
country: United States
facility: Office of Constantine Falliers, MD
state: Colorado
city: Ft. Lauderdale
country: United States
facility: Office of Gary Richmond, MD
state: Florida
city: Ft. Myers
country: United States
facility: CNS Clinical Trials
state: Florida
city: Kissimmee
country: United States
facility: FPA Clinical Research
state: Florida
city: Longwood
country: United States
facility: Orlando Clinic for Asthma & Respiratory Diseases
state: Florida
city: Miami
country: United States
facility: Allergy Sinus Asthma Research Institute
state: Florida
city: Miami
country: United States
facility: Florida Center for Alergy & Asthma Research
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: Atlanta
country: United States
facility: Family Allergy & Asthma Center, PC
state: Georgia
city: Conyers
country: United States
facility: The Allergy & Asthma Clinic Research Center
state: Georgia
city: Savannah
country: United States
facility: Aeroallergy Research
state: Georgia
city: Bloomington
country: United States
facility: Sneeze, Wheeze and Itch, LLC
state: Illinois
city: Chicago
country: United States
facility: Rush Presbyterian - St. Luke's Medical Center
state: Illinois
city: Glenview
country: United States
facility: Children's Asthma Respiratory & Exercise Specialists
state: Illinois
city: Springfield
country: United States
facility: Cardinal Respiratory, PC
state: Illinois
city: Indianapolis
country: United States
facility: Clinical Research Center of Indiana
state: Indiana
city: South Bend
country: United States
facility: South Bend Clinic
state: Indiana
city: Olathe
country: United States
facility: Consultants in Pulmonary Medicine
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates
state: Kansas
city: Covington
country: United States
facility: Northshore Medical Research
state: Louisiana
city: Wheaton
country: United States
facility: Institute for Asthma & Allergy, PC
state: Maryland
city: Taunton
country: United States
facility: Center for Clinical Research
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital & Medical Centers
state: Michigan
city: Flint
country: United States
facility: Hurley Child and Adolescent Asthma Center
state: Michigan
city: Minneapolis
country: United States
facility: Clinical Research Institute
state: Minnesota
city: Jefferson City
country: United States
facility: Allergy, Asthma, Immunology Services, LLC
state: Missouri
city: St. Charles
country: United States
facility: Midwest Chest Consultants, PC
state: Missouri
city: St. Louis
country: United States
facility: Washington University School of Medicine, Division of Allergy & Immunology
state: Missouri
city: Missoula
country: United States
facility: Montana Medical Research, LLC
state: Montana
city: Lincoln
country: United States
facility: Allergy, Asthma & Immunology Associates, PC
state: Nebraska
city: Omaha
country: United States
facility: Heartland Clinical Research Inc.
state: Nebraska
city: Omaha
country: United States
facility: Office of Meera Dewan, MD
state: Nebraska
city: Cherry Hill
country: United States
facility: Delaware Valley Institute for Clinical Research
state: New Jersey
city: Tinton Falls
country: United States
facility: Clinical Research Center of Allergy & Asthma Consultants
state: New Jersey
city: Albuquerque
country: United States
facility: Lovelace Scientific Resources
state: New Mexico
city: Los Alamos
country: United States
facility: Allergy & Asthma of Northern NM
state: New Mexico
city: Bay Shore
country: United States
facility: Pulmonary Medical Research of NY
state: New York
city: Cortland
country: United States
facility: Asthma & Allergy Associates, PC
state: New York
city: Staten Island
country: United States
facility: Office of Michael Marcus, MD
state: New York
city: Tonawanda
country: United States
facility: Office of Richard Castaldo
state: New York
city: Asheville
country: United States
facility: Regional Allergy & Asthma Consultants
state: North Carolina
city: Charlotte
country: United States
facility: Charlotte Lung & Health Center
state: North Carolina
city: Charlotte
country: United States
facility: Neem Research Group, Inc.
state: North Carolina
city: High Point
country: United States
facility: Cornerstone Research Care
state: North Carolina
city: Winston-Salem
country: United States
facility: Carolina MedTrials, LLC
state: North Carolina
city: Fargo
country: United States
facility: Allergy & Asthma Care Center
state: North Dakota
city: Cincinnati
country: United States
facility: Sterling Research Group
state: Ohio
city: Cincinnati
country: United States
facility: New Horizons Clinical Research
state: Ohio
city: Columbus
country: United States
facility: Optimed Research LLC
state: Ohio
city: Oklahoma City
country: United States
facility: Allergy, Asthma & Clinical Research Center
state: Oklahoma
city: Lake Oswego
country: United States
facility: Allergy, Asthma and Dermatology Research Center
state: Oregon
city: Medford
country: United States
facility: Medford Medical Clinic, LLP
state: Oregon
city: Bellevue
country: United States
facility: Bellevue Pediatric Associates
state: Pennsylvania
city: Easton
country: United States
facility: Valley Clinical Research Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Allergy & Asthma Research of NJ, Inc.
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Shillington
country: United States
facility: Advanced Clinical Concepts
state: Pennsylvania
city: Charleston
country: United States
facility: Neem Research Group of Charleston
state: South Carolina
city: Columbia
country: United States
facility: Neem Research Group Inc.
state: South Carolina
city: Greenville
country: United States
facility: Allergic Disease & Asthma Center, PA
state: South Carolina
city: Chattanooga
country: United States
facility: Asthma Institute
state: Tennessee
city: Knoxville
country: United States
facility: The Allergy Associates
state: Tennessee
city: Amarillo
country: United States
facility: Office of Constantine Saadeh
state: Texas
city: Austin
country: United States
facility: Allergy & Asthma Clinical of Central Texas
state: Texas
city: Galveston
country: United States
facility: UTX Medical
state: Texas
city: Houston
country: United States
facility: Breco Research
state: Texas
city: Houston
country: United States
facility: Breath of Life Research Institute
state: Texas
city: Houston
country: United States
facility: Clinical Trials of North Houston
state: Texas
city: New Braunfels
country: United States
facility: Central Texas Health Research
state: Texas
city: San Antonio
country: United States
facility: Lung Diagnostics
state: Texas
city: Norfolk
country: United States
facility: Hampton Roads Center for Clinical Research
state: Virginia
city: Richmond
country: United States
facility: Pulmonary Associates of Richmond Inc.
state: Virginia
city: Richmond
country: United States
facility: Virginia Adult & Pediatric Allergy & Asthma PC
state: Virginia
city: Richmond
country: United States
facility: National Clinical Research
state: Virginia
city: Spokane
country: United States
facility: The Physician's Clinic of Spokane
state: Washington
city: Greenfield
country: United States
facility: Allergy, Asthma, and Sinus Center F.C.
state: Wisconsin
city: Milwaukee
country: United States
facility: Milwaukee Medical Clinic
state: Wisconsin
city: West Allis
country: United States
facility: Allergic Diseases, S.C.
state: Wisconsin
city: Vancouver
country: Canada
facility: Trial Management Group
state: British Columbia
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital
state: Manitoba
city: Mississauga
country: Canada
facility: Clinical Research Group
state: Ontario
city: Niagara Falls
country: Canada
facility: Niagara Clinical Research, Inc.
state: Ontario
city: Toronto
country: Canada
facility: Primary Care Lung Clinic
state: Ontario
Study officials:
References: