Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older With Asthma

Condition(s) targeted: Asthma

Intervention: levalbuterol tartrate MDI (Drug); racemic albuterol MDI (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Sepracor, Inc.

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).

Official title: An Efficacy and Safety Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older With Asthma

Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study

Primary outcome: percent change in FEV1 from visit predose averaged over the 8-week double-blind period

Secondary outcome:

area under the FEV1 percent change curve from visit pre-dose and from study baseline curves averaged over the double-blind period

peak percent change in FEV1 from study baseline

peak change in FEV1 from visit predose

peak percent of predicted FEV1

area under the FEV1 curve (AUC)

peak change and peak percent change in FEF25-75% from visit predose

peak change and peak percent change in FVC from visit predose

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.

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

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

Alabama Asthma and Allergy Center, Homewood, Alabama 35209, United States

MDC Research, Mobile, Alabama 36607, United States

Bensch Research Associates, Stockton, California 95207, United States

Allergy & Asthma Prevention & Treatment Center, San Diego, California 92131, United States

Allergy Research Foundation, Inc., Los Angeles, California 90025, United States

Clinical Trials of Orange County, Orange, California 92868, United States

Allergy & Asthma Assoc. of Santa Clara Valley Research Center, San Jose, California 95117, United States

Allergy, Asthma & Respiratory Care Center, Long Beach, California 90806, United States

Allergy & Asthma Medical Group & Research Center, San Diego, California 92123, United States

Integrated Research Group, Corona, California 92879, United States

Radiant Research, Inc., Encinitas, California 92024, United States

Allergy Associates Medical Group, San Diego, California 92120, United States

Allergy & Asthma Medical Group of Diablo Valley, Inc., Danville, California 94526, United States

Southern California Research Center, Viejo, California 92691, United States

Allergy & Asthma Specialists Medical Group, Huntington Beach, California 92647, United States

Clinical Research Centers of Colorado PC, Englewood, Colorado 80112, United States

National Jewish Medical & Research Center, Denver, Colorado 80206, United States

Asthma & Allergy Associates, PC, Pueblo, Colorado 81001, United States

Office of Ronald Saff, Tallahassee, Florida 32308, United States

Aeroallergy Research Laboratories of Savannah, Inc., Savannah, Georgia 31406, United States

Radiant Research Honolulu, Honolulu, Hawaii 96814, United States

Clinical Research Center of Indiana, Indianapolis, Indiana 46208, United States

Northshore Medical Research, Slidell, Louisiana 70458, United States

Allergy & Asthma Care Specialists, Metairie, Louisiana 70006, United States

University of Maryland School of Medicine, Baltimore, Maryland, United States

Northeast Medical Research Associates, Inc., N. Dartmouth, Massachusetts 02747, United States

PCHI, Needham, Massachusetts 02494, United States

Center for Clinical Research, Taunton, Massachusetts 02780, United States

Henry Ford Health System, Detroit, Michigan 48202, United States

Clinical Research Institute, Minneapolis, Minnesota 55402, United States

Mississippi Asthma & Allergy Clinic, Jackson, Mississippi, United States

Office of Clinical Research, University of Missouri-Columbia, Columbia, Missouri 65212, United States

Division of Allergy & Immunology, Washington Univ School of Med, St. Louis, Missouri 63110, United States

The Clinical Research Center, LLC, St. Louis, Missouri 63141, United States

St. Louis University, St. Louis, Missouri 63110, United States

The Children's Mercy Hospital, Kansas City, Missouri 64108, United States

Pulmonary and Allergy Associates, Springfield, New Jersey 07081, United States

Princeton Center for Clinical Research, Princeton, New Jersey 08540, United States

AAIR Research Center, Rochester, New York 14618, United States

PCCS, Albany, New York 12205, United States

Raleigh Pediatric Associates, Raleigh, North Carolina 27609, United States

Regional Allergy & Asthma Consultants, Asheville, North Carolina 28801, United States

Cornerstone Research Care, High Point, North Carolina 27262, United States

Bernstein Clinical Research Center, LLC, Cincinnati, Ohio 45231, United States

Allergy & Asthma Research, Eugene, Oregon 97401, United States

Allergy Associates Research Center, LLC, Portland, Oregon 97213, United States

University of Pittsburgh Division of Pulmonary, Pittsburgh, Pennsylvania 15213, United States

Temple University Hospital, Philadelphia, Pennsylvania 19140, United States

Asthma & Allergy Research Associates, Chester, Pennsylvania 19013, United States

Children's Hospital of Pittsburgh Division of Allergy, Immunology & Infectious Diseases, Pittsburgh, Pennsylvania 15213, United States

Allergy & Asthma Consultants, LLP, Mt. Pleasant, South Carolina 29464, United States

Radiant Research, Charleston, South Carolina 29407, United States

Office of Neil Kao, Greenville, South Carolina 29607, United States

Breath of Life Research Institute, Houston, Texas 77054, United States

Allergy & Asthma Center, Waco, Texas, United States

Lung Diagnostics, San Antonio, Texas, United States

North Texas Institute for Clinical Trials, Fort Worth, Texas 76132, United States

Allergy & Asthma Research Associates, Dallas, Texas 75231, United States

Office of Constantine Saadeh, Amarillo, Texas 79106, United States

Children's Hospital of the Kings Daughters, Norfolk, Virginia 23507, United States

Pulmonary Associates of Richmond, Inc., Richmond, Virginia 23225, United States

ASTHMA, Inc., Seattle, Washington 98105, United States

Allergic Diseases, SC, West Allis, Wisconsin 53227, United States

Starting date: May 2002
Ending date: January 2003
Last updated: June 6, 2008