A Safety, Efficacy and Tolerability Study in Pediatric Subjects With Asthma

Condition(s) targeted: Asthma

Intervention: Levalbuterol (Drug); Levalbuterol UDV TID (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Sepracor, Inc.

Overall contact:
Central Contact, Phone: 1-866-503-6351

A Safety, Efficacy, and Tolerability Study of Daily Dosing with Levalbuterol Tartrate HFA MDI and Placebo in Subjects Aged Birth to <48 Months with Asthma.

Official title: A Safety, Efficacy, and Tolerability Study of Daily Dosing With Levalbuterol Tartrate HFA MDI and Placebo in Subjects Aged Birth to <48 Months With Asthma

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change from baseline to Visit 4 in the mean daily composite score based on the Pediatric Asthma Caregiver Assessments

Secondary outcome:

Changes from baseline to Visits 3 and 4 in the mean daily composite score based on the daytime and nighttime asthma symptom scores

Change and percent change in the in-clinic PEF value from study baseline (Visit 2 predose) to postdose timepoints at Visit 2,3,4 timepoints in those subjects aged 24 to <48 months able to perform acceptable and reproducible PEF man

Change and percent change in the at-home mean daily PEF value from study baseline (mean of the daily PEF values from Visit 1 and 2) to Visits 3 and 4 (mean of the daily PEF values in the week prior to the visit) in subjects aged 24 to <48 month

Detailed description: This is a modified-blind, randomized, placebo-controlled, multicenter, parallel-group trial of levalbuterol HFA MDI administered using a facemask and holding chamber in subjects birth to <48 months with asthma.

Minimum age: N/A. Maximum age: 48 Months. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subject's parent/legal guardian must give written informed consent, including privacy

authorization, prior to study participation. Complete documentation regarding the consent process must be recorded in the case report form (CRF) and source documentation.

- Subject's parent/legal guardian must be willing and able to comply with the study

procedures and visit schedules.

- Subject, male or female, must be between the ages of birth and <48 months, exclusive,

at the time of consent.

- Subjects 24 to <48 months of age must have a history of physician-diagnosed asthma

(defined as at least 3 episodes of respiratory symptoms consistent with asthma symptoms including, but not limited to, cough, wheeze, or dyspnea). Subjects 0 to <24 months of age must have a history of 3 episodes of respiratory symptoms that in the judgement of the investigator could be consistent with asthma or reactive airways disease

- Subject must be in good health and not affected by any other chronic conditions,

including respiratory disorders other than asthma

Exclusion Criteria:

- Subject who requires or is expected to require any disallowed medications.

- Subject who has participated in an investigational drug study within 30 days, or who

is currently participating in another clinical trial.

- Subject or parent/legal guardian who has daily commitments during the study that

would interfere with trial measurements, compliance, or both.

- Subject who has a history of hospitalization for asthma, reactive airways disease, or

bronchospasm within 4 weeks or who is scheduled for in-patient hospitalization, including elective surgery during the course of the trial.

- Subject who has experienced significant blood loss within 60 days of study drug.

- Subject with a clinical diagnosis of cystic fibrosis.

- Subject who was born prematurely, defined as less than 38 weeks gestational age at

birth, and is <1 year of age.

- Subject whose body weight is less than 8. 0 kg. This minimum weight requirement is

based upon standard pediatric growth charts [CDC 2000].

- Subject with 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 levalbuterol or racemic albuterol

sulfate administration is contraindicated.

- Subject with a history of life-threatening asthma, defined as previous asthma

episodes requiring intubation or associated with hypercapnia, respiratory arrest, or hypoxic seizures.

- Subject with clinically significant abnormalities that may interfere with the

metabolism or excretion of the study drugs or study participation (eg, abnormalities of renal, hepatic, metabolic, or endocrine function).

- Subject with a history of cancer.

- Subject with any chronic or congenital cardiorespiratory condition other than asthma

including, but not limited to, bronchopulmonary dysplasia, congenital heart disease, and cystic fibrosis.

- Subject affected by an upper or lower respiratory tract infection in the 3 weeks

prior to Visit 1.

- Subject with a history of ventilation for a respiratory condition occurring at or

near birth, including those associated with prematurity or bronchopulmonary dysplasia. Ventilatory support for elective non-cardiopulmonary surgery is not exclusionary.

- Subject with any clinically significant abnormal laboratory values (hematology, blood

chemistry).

- Subject with a clinically significant abnormal 12-lead ECG that would put the subject

at risk for experiencing adverse cardiac effects.

- Subject who is a relative of a staff member.

Central Contact, Phone: 1-866-503-6351

Little Rock Allergy & Asthma Clinical Research Center, Little Rock, Arkansas 72205, United States; Recruiting
Study Coordinator, Phone: 501-224-1156

Clinical Trials of Orange County, Inc., Orange, California 92868, United States; Recruiting
Study Coordinator, Phone: 714-744-2773

Allergy & Asthma Care Center of Southern California, Long Beach, California 90808, United States; Recruiting
Study Coordinator, Phone: 562-429-3329

Allergy and Asthma Consultants, Redwood, California 94063, United States; Recruiting
Study Coordinator, Phone: 650-216-6111

All Seasons Allergy and Asthma Center, P.A., Fort Walton Beach, Florida 32547, United States; Recruiting
Study Coordinator, Phone: 850-862-3020

Brookstone Centre Parkway, Columbus, Georgia 31904, United States; Recruiting
Study Coordinator, Phone: 706-324-4012

Sneeze, Wheeze & Itch Associates LLC, Normal, Illinois 61761, United States; Recruiting
Study Coordinator, Phone: 309-452-0995

Northern Illinois Research Associates, DeKalb, Illinois 60115, United States; Recruiting
Study Coordinator, Phone: 815-758-5100

Nassim, McMonigle, Mescia & Associates, New Albany, Indiana 47150, United States; Recruiting
Study Coordinator, Phone: 502-231-1982

Grand Blanc Medical, Grand Blanc, Michigan 48439, United States; Recruiting
Study Coordinator, Phone: 810-953-3600

Craig A. Spiegel MD, Bridgeton, Missouri 63044, United States; Recruiting
Study Coordinator, Phone: 314-913-0172

Midwest Allergy and Asthma center, Omaha, Nebraska 68130, United States; Recruiting
Study Coordinator, Phone: 402-778-3650

The Asthma & Allergy Center, P.C., Papillion, Nebraska 68046, United States; Recruiting
Study Coordinator, Phone: 402-592-2055

Maimonides Medical Center, Brooklyn, New York 11219, United States; Recruiting
Study Coordinator, Phone: 718-283-6251

Dayton Clinical Research, Dayton, Ohio 45406, United States; Recruiting
Study Coordinator, Phone: 937-276-4311

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio 45229, United States; Recruiting
Study Coordinator, Phone: 513-636-6771

Allergy, Asthma and clinical Research Center, Oklahoma City, Oklahoma 73120, United States; Recruiting
Study Coordinator, Phone: 405-752-0393

Eminence Research, LLC, Oklahoma City, Oklahoma 73139, United States; Recruiting
Study Coordinator, Phone: 405-632-2815

Asthma and Allergy Research Associates, Upland, Pennsylvania 19013, United States; Recruiting
Study Coordinator, Phone: 610-876-2103

ADAC Research, PA, Greenville, South Carolina 29607, United States; Recruiting
Study Coordinator, Phone: 864-627-3800, Ext: 214

AAC Research - PC, Charleston, South Carolina 29414, United States; Recruiting
Study Coordinator, Phone: 843-576-2538

The Asthma Institute, PLLC, Chattanooga, Tennessee 37421, United States; Recruiting
Study Coordinator, Phone: 423-308-1818

Live Oak Allergy and Asthma Clinic, Live Oak, Texas 78233, United States; Recruiting
Study Coordinator, Phone: 210-646-6978

Quality Assurance Research Center, Inc., San Antonio, Texas 78205, United States; Recruiting
Study Coordinator, Phone: 210-341-2002

Western Sky Medical Research, El Paso, Texas 79903, United States; Recruiting
Study Coordinator, Phone: 915-544-2557

West Houston Clinical Research Service, Houston, Texas 77055, United States; Recruiting
Study Coordinator, Phone: 281-738-2642

Allergy & Asthma Care of Waco, Waco, Texas 76712, United States; Recruiting
Study Coordinator, Phone: 254-753-3646

Allergy and Asthma Research Institute, Waco, Texas 76712, United States; Recruiting
Study Coordinator, Phone: 254-751-1144

Dallas Allergy Immunology Research, Dallas, Texas 75230, United States; Recruiting
Study Coordinator, Phone: 972-566-6831

Virginia Adult and Pediatric Allergy and Asthma, PC, Richmond, Virginia 23229, United States; Recruiting
Study Coordinator, Phone: 804-282-2471

PI-Coor Clinical Research, LLC, Burke, Virginia 22015, United States; Recruiting
Study Coordinator, Phone: 703-426-0800

Bellingham Asthma, Allergy, & Immunology Clinic, Bellingham, Washington 98225, United States; Recruiting
Study Coordinator, Phone: 360-733-5733

Starting date: December 2008
Ending date: January 2011
Last updated: August 21, 2009