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

NCT00073814 | Completed Phase 3

• 1 other identifier: 051-354
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 45

Brief Summary

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

Conditions

Asthma

Keywords

levalbuterol; pediatric; asthma

Outcome Measures

Primary Outcomes (1)

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

  Week 0, 2, 4

Secondary Outcomes (12)

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

  Week 0, 2, 4

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

  Week 0, 2, 4

• peak change in FEV1 from visit predose to each visit

  Week 0, 2, 4

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

  Week 0, 2, 4

• time to peak change

  Week 0, 2, 4

Study Arms (3)

1

EXPERIMENTAL

levalbuterol MDI 90 mcg QID

Drug: Levalbuterol tartrate MDI

2

ACTIVE COMPARATOR

racemic albuterol MDI 190 mcg QID

Drug: racemic albuterol MDI

3

PLACEBO COMPARATOR

Placebo MDI QID

Drug: Placebo

Interventions

Levalbuterol tartrate MDI DRUG

levalbuterol MDI 90 mcg QID

Also known as: Xopenex MDI

1

racemic albuterol MDI DRUG

racemic albuterol MDI 180 mcg QID

2

Placebo DRUG

Placebo MDI QID

3

Eligibility Criteria

• Age: 4 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (45)

Adolescent & Pediatric Associates, PC

Montgomery, Alabama, 36116, United States

Location

The Children's Clinic of Jonesboro, PA

Jonesboro, Arkansas, 72401, United States

Location

Integrated Research Group

Corona, California, 92879, United States

Location

Allergy & Asthma Specialists Medical Group

Huntington Beach, California, 92647, United States

Location

Asthma, Allergy & Respiratory Care Center

Long Beach, California, 90808, United States

Location

Madera Family Medical Group

Madera, California, 93637, United States

Location

Southern California Research

Mission Viejo, California, 92692, United States

Location

CHOC, PSF, AMC Disision of Allergy, Asthma & Immunology

Orange, California, 92868, United States

Location

Clinical Trials of Orange County

Orange, California, 92868, United States

Location

Allergy Associates Medical Group

San Diego, California, 92120, United States

Location

West Coast Clinical Trials, Inc.

Signal Hill, California, 90755, United States

Location

Allergy & Asthma Medical Group of Diablo Valley, Inc.

Walnut Creek, California, 94598, United States

Location

Asthma & Allergy Associates

Colorado Springs, Colorado, 80907, United States

Location

National Jewish Medical & Research Center

Denver, Colorado, 80206, United States

Location

The Allergy & Asthma Clinical Research Center

Lawrenceville, Georgia, 30045, United States

Location

Aeroallergy Research Laboratories of Savannah, Inc.

Savannah, Georgia, 31406, United States

Location

Department of Pediatric Critical Care, Kosair Children's Hospital

Louisville, Kentucky, 40202, United States

Location

The Pediatric Clinic

Bogalusa, Louisiana, 70429, United States

Location

Doctor's Care

New Orleans, Louisiana, 70122, United States

Location

Dolby Providers, Inc

New Orleans, Louisiana, 70127, United States

Location

Radiant Research

Bridgeton, Missouri, 63044, United States

Location

Essex-Morris Pediatric Group

Livingston, New Jersey, 07960, United States

Location

Princeton Center for Clinical Research

Princeton, New Jersey, 08540, United States

Location

Summit Pediatric Pulmonology

Summit, New Jersey, 07901, United States

Location

University of New Mexico, Health Sciences Center

Albuquerque, New Mexico, 87131, United States

Location

Pulmonary Associates of Mobile, PC

Ithaca, New York, 14850, United States

Location

Regional Allergy & Asthma Consultants, PA

Asheville, North Carolina, 28801, United States

Location

Pediatric Associates of Mt. Carmel

Cincinnati, Ohio, 45245, United States

Location

University Hospitals of Cleveland, Rainbow Babies & Children's Hospital

Cleveland, Ohio, 44106, United States

Location

Dr. Senders & Associates

University Heights, Ohio, 44118, United States

Location

Sooner Clinical Research

Oklahoma City, Oklahoma, 73112, United States

Location

Allergy & Asthma and Dermatology Research Center

Lake Oswego, Oregon, 97035, United States

Location

Clinical Research Institute of Southern Oregon

Medford, Oregon, 97504, United States

Location

Allergy Associates Research Center

Portland, Oregon, 97213, United States

Location

Bellevue Pediatric Association

Pittsburgh, Pennsylvania, 15202, United States

Location

Allergy & Asthma Consultants

Mt. Pleasant, South Carolina, 29464, United States

Location

Allergy, Asthma & Sinus Center, PC

Knoxville, Tennessee, 37922, United States

Location

Vanderbilt University ASAP Research

Nashville, Tennessee, 37203, United States

Location

Pediatric Allergy/Immunology Associates

Dallas, Texas, 75230, United States

Location

North Texas Institute for Clinical Trials

Fort Worth, Texas, 76132, United States

Location

Allergy & Asthma Associates

Houston, Texas, 77054, United States

Location

Breath of Life Research Institute

Houston, Texas, 77084, United States

Location

Sun Research Institute

San Antonio, Texas, 78205, United States

Location

PI- Coor Clinical Research, LLC

Burke, Virginia, 22015, United States

Location

Allergy & Asthma Associates

Kirkland, Washington, 98034, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2003
• First Posted: December 10, 2003
• Study Start: December 1, 2002
• Primary Completion: June 1, 2003
• Study Completion: June 1, 2003
• Last Updated: February 22, 2012

Record last verified: 2012-02

Locations

US (45)