Clinical trial NCT00073840: 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: levalbuterol
asthma
bronchoconstriction
adolescent
adult
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2003-12-11
Enrollment: 386
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 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: FEV1 (peak percent change from pre-dose averaged over the double-blind period).
timeFrame: 8 weeks
Secondary outcomes:
measure: --FEV1 [area under the % change from pre-dose FEV1 curve] and FEV1 [area under the % change from study baseline FEV1 curve]
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Oxford
country: United States
facility: Allergy & Asthma Center, LLC
state: Alabama
city: Tucson
country: United States
facility: Alta Clinical Research
state: Arizona
city: Corona
country: United States
facility: Integrated Research Group
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: Asthma, Allergy & Respiratory Care Center
state: California
city: Los Angeles
country: United States
facility: Allergy Research Foundation, Inc.
state: California
city: Madera
country: United States
facility: Madera Family Medical Group
state: California
city: Mission Viejo
country: United States
facility: Southern California Research
state: California
city: Oakland
country: United States
facility: Comprehensive Allergy Services
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 Jose
country: United States
facility: Allergy & Asthma Assoc. of Santa Clara Valley Research Center
state: California
city: Signal Hill
country: United States
facility: West Coast Clinical Trials
state: California
city: Walnut Creek
country: United States
facility: Allergy & Asthma Medical Group of Diablo Valley, Inc.
state: California
city: Thornton
country: United States
facility: 1st Allergy & Asthma Clinical Research Ctr
state: Colorado
city: Barnesville
country: United States
facility: Watts Medical Research
state: Georgia
city: Conyers
country: United States
facility: The Allergy & Asthma Clinical Research Center
state: Georgia
city: Savannah
country: United States
facility: Aeroallergy Research Laboratories of Savannah, Inc.
state: Georgia
city: Chicago
country: United States
facility: Rush Presbyterian - St. Luke's Medical Center Rush University
state: Illinois
city: South Bend
country: United States
facility: South Bend Clniic
state: Indiana
city: Metairie
country: United States
facility: Clinical Research Specialist
state: Louisiana
city: New Orleans
country: United States
facility: Doctor's Care
state: Louisiana
city: Slidell
country: United States
facility: Children's International Medical Research
state: Louisiana
city: Minneapolis
country: United States
facility: Clinical Research Institute
state: Minnesota
city: St. Louis
country: United States
facility: The Clinical Research Center, LLC
state: Missouri
city: Omaha
country: United States
facility: Heartland Clinical Research Inc.
state: Nebraska
city: Papillion
country: United States
facility: Asthma & Allergy Center PC
state: Nebraska
city: Las Vegas
country: United States
facility: Office of Yekaterina Khronusova, MD
state: Nevada
city: Bay Shore
country: United States
facility: Pulmonary Medical Research of NY, PLLC
state: New York
city: Cortland
country: United States
facility: Asthma & Allergy Associates PC
state: New York
city: Rochester
country: United States
facility: AAIR Research Center
state: New York
city: Tonawanda
country: United States
facility: Office or Richard Castaldo, MD
state: New York
city: Charlotte
country: United States
facility: Charlotte Lung and Health Center
state: North Carolina
city: Elizabeth City
country: United States
facility: Albermarle Allergy & Asthma PC
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Medical Research
state: North Carolina
city: Cincinnati
country: United States
facility: New Horizons Clinical Research, Inc.
state: Ohio
city: Oklahoma City
country: United States
facility: Allergy, Asthma & Clinical Research Center
state: Oklahoma
city: Portland
country: United States
facility: Allergy Associates Research Center, LLC
state: Oregon
city: Easton
country: United States
facility: Valley Clinical Research Center
state: Pennsylvania
city: Temple
country: United States
facility: Advanced Clinical Concepts
state: Pennsylvania
city: Greenville
country: United States
facility: Allergic Disease & Asthma Center PA
state: South Carolina
city: Mt. Pleasant
country: United States
facility: Allergy & Asthma Consultants, LLP
state: South Carolina
city: Austin
country: United States
facility: Allergy and Asthma Clinic of Central Texas
state: Texas
city: Dallas
country: United States
facility: Research Across America
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: San Antonio
country: United States
facility: Lung Diagnostics
state: Texas
city: Burke
country: United States
facility: PI - Coor Clinical Research, LLC
state: Virginia
city: Richmond
country: United States
facility: Pulmonary Associates of Richmond, inc.
state: Virginia
city: Spokane
country: United States
facility: Rockwood Clinics, PS
state: Washington
city: Greenfield
country: United States
facility: Allergy, Asthma and Sinus Center F.C.
state: Wisconsin
city: West Allis
country: United States
facility: Allergic Diseases, SC
state: Wisconsin
Study officials:
affiliation: Sumitomo Pharma America, Inc.
name: John Hanrahan, M.D.
role: STUDY_CHAIR
References:
citation: Duan QL, Gaume BR, Hawkins GA, Himes BE, Bleecker ER, Klanderman B, Irvin CG, Peters SP, Meyers DA, Hanrahan JP, Lima JJ, Litonjua AA, Tantisira KG, Liggett SB. Regulatory haplotypes in ARG1 are associated with altered bronchodilator response. Am J Respir Crit Care Med. 2011 Feb 15;183(4):449-54. doi: 10.1164/rccm.201005-0758OC. Epub 2010 Sep 17.