Study of Daily Dosing With Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects 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.

Study of Daily Dosing with Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects with Asthma

Official title: An Efficacy, Safety, and Tolerability Study of Daily Dosing With Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects With Asthma

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

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

Secondary outcome:

under the FEV1 percent change from visit predose curve averaged over the double-blind period

peak change and peak percent change in FEV1 from visit predose to each visit

peak change in FEV1 from visit predose to each visit

peak percent change in FEV1 from study baseline over the double blind period

time to peak change

peak percent of predicted FEV1 at each visit and over the double-blind period

area under the FEV1 percent change from predose curve at each visit

area under the FEV1 percent change from study baseline curve at each visit and averaged over the double-blind period

percent of predicted FEV1 AUC at each visit

percent change in predose FEV1 from study baseline at each visit

number and percent of responders

time to onset of response and duration of response

Detailed description: This was a Phase III, double-blind, randomized, placebo- and active-controlled, multicenter, parallel-group study of up to 6 weeks in duration. Seven days of QID single-blind, placebo administration (via HFA MDI) was followed by 28 days of QID, double-blind treatment. A follow-up visit was required only for subjects who had, in the opinion of the investigator, a clinically significant finding at Visit 6 /ET that would put the subject at risk. A final follow up phone evaluation was conducted 7 days after the completion of Visit 6/ET.

Minimum age: 4 Years. Maximum age: 11 Years. Gender(s): Both.

Criteria:

Inclusion Criteria

- Subject and subject's p/l guardian must be willing and able to comply with the study

procedures and visit schedules

- Subject, male or female, between the ages of 4 to 11 yrs

- Female subjects 8 yrs or older will have a negative serum pregnancy test

- Must 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 over-the-counter asthma medication for at least 6 mos. prior to study start

- Must be in good health with the exception of 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

- Subject's p/l guardian must be able to complete the diary cards and medical event

calendars reliably on a daily basis, understand dosing instructions and questionnaire completion, 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

- Schedule prevents him or her from taking the first daily dose of study medication

and/or starting study visits before 9 AM

- Have travel commitments during the study that would interfere with trial measurements

or compliance or both

- Have a history of hospitalization for asthma within 60 days prior to study start, or

who is scheduled for in-patient hospitalization, including elective surgery during the course of 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

- Have currently diagnosed life-threatening asthma defined as a history of asthma

episodes requiring intubation, associated with hypercapnia, respiratory arrest, or hypoxic seizures within 3 mos. prior to study start

- Have a history of cancer

- Subject with hyperthyroidism, diabetes, hypertension, cardiac diseases or seizure

disorders that currently are not well controlled by medication or that may interfere with the successful completion of this protocol

- Have a history of substance abuse or drug abuse within 12 months preceding V1 or a

positive urine drug screening at study start

- Have a documented history of bronchopulmonary aspergillosis or any form of allergic

alveolitis

- Has suffered from a clinically significant upper or lower respiratory tract infection

in the 2 wks prior to study start

- Have a history of cigarette smoking or use of any tobacco products

- Subject who is a relative of a staff member

Adolescent & Pediatric Associates, PC, Montgomery, Alabama 36116, United States

The Children's Clinic of Jonesboro, PA, Jonesboro, Arkansas 72401, United States

Southern California Research, Mission Viejo, California 92692, United States

CHOC, PSF, AMC Disision of Allergy, Asthma & Immunology, Orange, California 92868, United States

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

Allergy & Asthma Medical Group of Diablo Valley, Inc., Walnut Creek, California 94598, United States

West Coast Clinical Trials, Inc., Signal Hill, California 90755, United States

Asthma, Allergy & Respiratory Care Center, Long Beach, California 90808, United States

Madera Family Medical Group, Madera, California 93637, United States

Integrated Research Group, Corona, California 92879, United States

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

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

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

Asthma & Allergy Associates, Colorado Springs, Colorado 80907, United States

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

The Allergy & Asthma Clinical Research Center, Lawrenceville, Georgia 30045, United States

Department of Pediatric Critical Care, Kosair Children's Hospital, Louisville, Kentucky 40202, United States

Dolby Providers, Inc, New Orleans, Louisiana 70127, United States

The Pediatric Clinic, Bogalusa, Louisiana 70429, United States

Doctor's Care, New Orleans, Louisiana 70122, United States

Radiant Research, Bridgeton, Missouri 63044, United States

Essex-Morris Pediatric Group, Livingston, New Jersey 07960, United States

Summit Pediatric Pulmonology, Summit, New Jersey 07901, United States

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

University of New Mexico, Health Sciences Center, Albuquerque, New Mexico 87131, United States

Pulmonary Associates of Mobile, PC, Ithaca, New York 14850, United States

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

Pediatric Associates of Mt. Carmel, Cincinnati, Ohio 45245, United States

University Hospitals of Cleveland, Rainbow Babies & Children's Hospital, Cleveland, Ohio 44106, United States

Dr. Senders & Associates, University Heights, Ohio 44118, United States

Sooner Clinical Research, Oklahoma City, Oklahoma 73112, United States

Allergy & Asthma and Dermatology Research Center, Lake Oswego, Oregon 97035, United States

Clinical Research Institute of Southern Oregon, Medford, Oregon 97504, United States

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

Bellevue Pediatric Association, Pittsburgh, Pennsylvania 15202, United States

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

Allergy, Asthma & Sinus Center, PC, Knoxville, Tennessee 37922, United States

Vanderbilt University ASAP Research, Nashville, Tennessee 37203, United States

Breath of Life Research Institute, Houston, Texas 77084, United States

Sun Research Institute, San Antonio, Texas 78205, United States

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

Allergy & Asthma Associates, Houston, Texas 77054, United States

Pediatric Allergy/Immunology Associates, Dallas, Texas 75230, United States

PI- Coor Clinical Research, LLC, Burke, Virginia 22015, United States

Allergy & Asthma Associates, Kirkland, Washington 98034, United States

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