Clinical trial NCT00073827: Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older With Asthma
Official title: An Efficacy and Safety Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: adolescent
adult
asthma
levalbuterol
bronchoconstriction
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2003-12-11
Enrollment: 445
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 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: percent change in FEV1 from visit predose averaged over the 8-week double-blind period
timeFrame: Weeks 0, 4, 8
Secondary outcomes:
measure: area under the FEV1 percent change curve from visit pre-dose and from study baseline curves averaged over the double-blind period
timeFrame: Weeks 0, 4, 8
measure: peak percent change in FEV1 from study baseline
timeFrame: Weeks 0, 4, 8
measure: peak change in FEV1 from visit predose
timeFrame: Weeks 0, 4, 8
measure: peak percent of predicted FEV1
timeFrame: Weeks 0, 4, 8
measure: area under the FEV1 curve (AUC)
timeFrame: Weeks 0, 4, 8
measure: peak change and peak percent change in FEF25-75% from visit predose
timeFrame: Weeks 0, 4, 8
measure: peak change and peak percent change in FVC from visit predose
timeFrame: Weeks 0, 4, 8
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Alabama Asthma and Allergy Center
state: Alabama
city: Mobile
country: United States
facility: MDC Research
state: Alabama
city: Corona
country: United States
facility: Integrated Research Group
state: California
city: Danville
country: United States
facility: Allergy & Asthma Medical Group of Diablo Valley, Inc.
state: California
city: Encinitas
country: United States
facility: Radiant Research, Inc.
state: California
city: Huntington Beach
country: United States
facility: Allergy & Asthma Specialists Medical Group
state: California
city: Long Beach
country: United States
facility: Allergy, Asthma & Respiratory Care Center
state: California
city: Los Angeles
country: United States
facility: Allergy Research Foundation, Inc.
state: California
city: Orange
country: United States
facility: Clinical Trials of Orange County
state: California
city: San Diego
country: United States
facility: Allergy Associates Medical Group
state: California
city: San Diego
country: United States
facility: Allergy & Asthma Medical Group & Research Center
state: California
city: San Diego
country: United States
facility: Allergy & Asthma Prevention & Treatment Center
state: California
city: San Jose
country: United States
facility: Allergy & Asthma Assoc. of Santa Clara Valley Research Center
state: California
city: Stockton
country: United States
facility: Bensch Research Associates
state: California
city: Viejo
country: United States
facility: Southern California Research Center
state: California
city: Denver
country: United States
facility: National Jewish Medical & Research Center
state: Colorado
city: Englewood
country: United States
facility: Clinical Research Centers of Colorado PC
state: Colorado
city: Pueblo
country: United States
facility: Asthma & Allergy Associates, PC
state: Colorado
city: Tallahassee
country: United States
facility: Office of Ronald Saff
state: Florida
city: Savannah
country: United States
facility: Aeroallergy Research Laboratories of Savannah, Inc.
state: Georgia
city: Honolulu
country: United States
facility: Radiant Research Honolulu
state: Hawaii
city: Indianapolis
country: United States
facility: Clinical Research Center of Indiana
state: Indiana
city: Metairie
country: United States
facility: Allergy & Asthma Care Specialists
state: Louisiana
city: Slidell
country: United States
facility: Northshore Medical Research
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
city: N. Dartmouth
country: United States
facility: Northeast Medical Research Associates, Inc.
state: Massachusetts
city: Needham
country: United States
facility: PCHI
state: Massachusetts
city: Taunton
country: United States
facility: Center for Clinical Research
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Minneapolis
country: United States
facility: Clinical Research Institute
state: Minnesota
city: Jackson
country: United States
facility: Mississippi Asthma & Allergy Clinic
state: Mississippi
city: Columbia
country: United States
facility: Office of Clinical Research, University of Missouri-Columbia
state: Missouri
city: Kansas City
country: United States
facility: The Children's Mercy Hospital
state: Missouri
city: St. Louis
country: United States
facility: Division of Allergy & Immunology, Washington Univ School of Med
state: Missouri
city: St. Louis
country: United States
facility: St. Louis University
state: Missouri
city: St. Louis
country: United States
facility: The Clinical Research Center, LLC
state: Missouri
city: Princeton
country: United States
facility: Princeton Center for Clinical Research
state: New Jersey
city: Springfield
country: United States
facility: Pulmonary and Allergy Associates
state: New Jersey
city: Albany
country: United States
facility: PCCS
state: New York
city: Rochester
country: United States
facility: AAIR Research Center
state: New York
city: Asheville
country: United States
facility: Regional Allergy & Asthma Consultants
state: North Carolina
city: High Point
country: United States
facility: Cornerstone Research Care
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Pediatric Associates
state: North Carolina
city: Cincinnati
country: United States
facility: Bernstein Clinical Research Center, LLC
state: Ohio
city: Eugene
country: United States
facility: Allergy & Asthma Research
state: Oregon
city: Portland
country: United States
facility: Allergy Associates Research Center, LLC
state: Oregon
city: Chester
country: United States
facility: Asthma & Allergy Research Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh Division of Allergy, Immunology & Infectious Diseases
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Division of Pulmonary
state: Pennsylvania
city: Charleston
country: United States
facility: Radiant Research
state: South Carolina
city: Greenville
country: United States
facility: Office of Neil Kao
state: South Carolina
city: Mt. Pleasant
country: United States
facility: Allergy & Asthma Consultants, LLP
state: South Carolina
city: Amarillo
country: United States
facility: Office of Constantine Saadeh
state: Texas
city: Dallas
country: United States
facility: Allergy & Asthma Research Associates
state: Texas
city: Fort Worth
country: United States
facility: North Texas Institute for Clinical Trials
state: Texas
city: Houston
country: United States
facility: Breath of Life Research Institute
state: Texas
city: San Antonio
country: United States
facility: Lung Diagnostics
state: Texas
city: Waco
country: United States
facility: Allergy & Asthma Center
state: Texas
city: Norfolk
country: United States
facility: Children's Hospital of the Kings Daughters
state: Virginia
city: Richmond
country: United States
facility: Pulmonary Associates of Richmond, Inc.
state: Virginia
city: Seattle
country: United States
facility: ASTHMA, Inc.
state: Washington
city: West Allis
country: United States
facility: Allergic Diseases, SC
state: Wisconsin
Study officials:
References: