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).
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
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
Allergy & Asthma Center, LLC, Oxford, Alabama 36203, United States
Alta Clinical Research, Tucson, Arizona 85745, United States
Integrated Research Group, Corona, California 92879, United States
Radiant Research, Inc., Encinitas, California 92024, United States
Allergy & Asthma Specialists Medical Group, Huntington Beach, California 92647, United States
Asthma, Allergy & Respiratory Care Center, Long Beach, California 90808, United States
Allergy Research Foundation, Inc., Los Angeles, California 90025, United States
Madera Family Medical Group, Madera, California 93637, United States
Southern California Research, Mission Viejo, California 92691, United States
Comprehensive Allergy Services, Oakland, California 94609, United States
Clinical Trials of Orange County, Orange, California 92868, United States
Allergy & Asthma Medical Group & Research Center, San Diego, California 92123, United States
Allergy Associates Medical Group, San Diego, California 92120, United States
Allergy & Asthma Assoc. of Santa Clara Valley Research Center, San Jose, California 95117, United States
West Coast Clinical Trials, Signal Hill, California 90755, United States
Allergy & Asthma Medical Group of Diablo Valley, Inc., Walnut Creek, California 94598, United States
1st Allergy & Asthma Clinical Research Ctr, Thornton, Colorado 80233, United States
Watts Medical Research, Barnesville, Georgia 30204, United States
The Allergy & Asthma Clinical Research Center, Conyers, Georgia 30013, United States
Aeroallergy Research Laboratories of Savannah, Inc., Savannah, Georgia 31406, United States
Rush Presbyterian - St. Luke's Medical Center Rush University, Chicago, Illinois 60612, United States
South Bend Clniic, South Bend, Indiana 46617, United States
Clinical Research Specialist, Metairie, Louisiana 70006, United States
Doctor's Care, New Orleans, Louisiana 70122, United States
Children's International Medical Research, Slidell, Louisiana 70458, United States
Clinical Research Institute, Minneapolis, Minnesota 55402, United States
The Clinical Research Center, LLC, St. Louis, Missouri 63141, United States
Heartland Clinical Research Inc., Omaha, Nebraska 68134, United States
Asthma & Allergy Center PC, Papillion, Nebraska 68046, United States
Office of Yekaterina Khronusova, MD, Las Vegas, Nevada 89119, United States
Pulmonary Medical Research of NY, PLLC, Bay Shore, New York 11706, United States
Asthma & Allergy Associates PC, Cortland, New York 13046, United States
AAIR Research Center, Rochester, New York 14618, United States
Office or Richard Castaldo, MD, Tonawanda, New York 14150, United States
Charlotte Lung and Health Center, Charlotte, North Carolina 28207, United States
Albermarle Allergy & Asthma PC, Elizabeth City, North Carolina 27909, United States
Piedmont Medical Research, Winston-Salem, North Carolina 27103, United States
New Horizons Clinical Research, Inc., Cincinnati, Ohio 45241, United States
Allergy, Asthma & Clinical Research Center, Oklahoma City, Oklahoma 73120, United States
Allergy Associates Research Center, LLC, Portland, Oregon 97213, United States
Valley Clinical Research Center, Easton, Pennsylvania 18045, United States
Advanced Clinical Concepts, Temple, Pennsylvania 19560, United States
Allergic Disease & Asthma Center PA, Greenville, South Carolina 29607, United States
Allergy & Asthma Consultants, LLP, Mt. Pleasant, South Carolina 29464, United States
Allergy and Asthma Clinic of Central Texas, Austin, Texas 78749, United States
Research Across America, Dallas, Texas 75234, United States
Breath of Life Research Institute, Houston, Texas 77084, United States
Breco Research, Houston, Texas 77024, United States
Lung Diagnostics, San Antonio, Texas 78229, United States
PI - Coor Clinical Research, LLC, Burke, Virginia 22015, United States
Pulmonary Associates of Richmond, inc., Richmond, Virginia 23225, United States
Rockwood Clinics, PS, Spokane, Washington 99220, United States
Allergy, Asthma and Sinus Center F.C., Greenfield, Wisconsin 53228, United States
Allergic Diseases, SC, West Allis, Wisconsin 53227, United States