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

Completed · Phase 3 · Has a placebo group

Conditions studied: Asthma

In brief

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

Key facts

Study ID

NCT00073814

Run by

Sumitomo Pharma America, Inc.

People needed

80

Starts

2002-12-01

Expected to finish

2003-06-01

Last updated by the study team

2012-02-22

Who can join

Age: 4 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Adolescent & Pediatric Associates, PC — Montgomery, Alabama, United States
• The Children's Clinic of Jonesboro, PA — Jonesboro, Arkansas, United States
• Integrated Research Group — Corona, California, United States
• Allergy & Asthma Specialists Medical Group — Huntington Beach, California, United States
• Asthma, Allergy & Respiratory Care Center — Long Beach, California, United States
• Madera Family Medical Group — Madera, California, United States
• Southern California Research — Mission Viejo, California, United States
• CHOC, PSF, AMC Disision of Allergy, Asthma & Immunology — Orange, California, United States
• Clinical Trials of Orange County — Orange, California, United States
• Allergy Associates Medical Group — San Diego, California, United States
• West Coast Clinical Trials, Inc. — Signal Hill, California, United States
• Allergy & Asthma Medical Group of Diablo Valley, Inc. — Walnut Creek, California, United States
• Asthma & Allergy Associates — Colorado Springs, Colorado, United States
• National Jewish Medical & Research Center — Denver, Colorado, United States
• The Allergy & Asthma Clinical Research Center — Lawrenceville, Georgia, United States
• Aeroallergy Research Laboratories of Savannah, Inc. — Savannah, Georgia, United States
• Department of Pediatric Critical Care, Kosair Children's Hospital — Louisville, Kentucky, United States
• The Pediatric Clinic — Bogalusa, Louisiana, United States
• Doctor's Care — New Orleans, Louisiana, United States
• Dolby Providers, Inc — New Orleans, Louisiana, United States
• Radiant Research — Bridgeton, Missouri, United States
• Essex-Morris Pediatric Group — Livingston, New Jersey, United States
• Princeton Center for Clinical Research — Princeton, New Jersey, United States
• Summit Pediatric Pulmonology — Summit, New Jersey, United States
• University of New Mexico, Health Sciences Center — Albuquerque, New Mexico, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.