A Study of Levalbuterol Tartrate HFA Inhalation Aerosol Metered Dose Inhaler (MDI) in Pediatric Subjects

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Asthma

In brief

This is a study of levalbuterol tartrate HFA inhalation aerosol MDI in pediatric subjects birth to ≤ 48 months of age who go to the Emergency Department (ED) or their physician's office with an acute bronchospasm. Subjects presenting to the ED or physician's office with an acute bronchospasm must have a history of reactive airways disease, based on subjects' parent/guardian report.

Key facts

Study ID

NCT02150499

Run by

Sumitomo Pharma America, Inc.

People needed

18

Starts

2014-07-01

Expected to finish

2014-12-01

Last updated by the study team

2016-04-08

Who can join

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

You may qualify if…

• Male or female from birth to 48 months of age, inclusive, whose parent(s) or legal guardian(s) provide written informed consent prior to study participation and are willing to comply with study procedures.
• Subject experiencing acute bronchospasm requiring a bronchodilator and who have a history of wheezing.

You may not qualify if…

• Subject with a severe illness that, in the opinion of the Investigator, could jeopardize subject safety.
• Subject received ≥ 8 puffs (MDI) of a beta-2 agonist or 2.5 mg of nebulized levalbuterol, or albuterol 5.0 mg within 4 hours prior to ED or physician's office admittance.
• Subject received ipratropium within 4 hours prior to ED or physician's office admittance.
• Subject who participated in an investigational drug study within 30 days prior to enrollment, or who previously participated in the current study.
• 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 (including beta-blockers) with which levalbuterol or racemic albuterol sulfate administration is contraindicated.
• Subject with a history of clinically significant abnormalities that could interfere with the metabolism or excretion of the study medication (eg, renal, hepatic, metabolic, or endocrine abnormalities).
• Subject with a history of cancer.

Where it is running

• Score Physician Alliance, LLC — St. Petersburg, Florida, United States
• Northern Illinios Research Associates — DeKalb, Illinois, United States
• Northern Illinois Associates — DeKalb, Illinois, United States
• Michael W. Simon, MD, PSC — Nicholasville, Kentucky, United States
• Willis-Knighton Physician Network / Portico Pediatrics — Shreveport, Louisiana, United States
• Mid Michigan Sleep Center — Grand Blanc, Michigan, United States
• Craig Spiegel, MD — Bridgeton, Missouri, United States
• St. Peter's University Hospital — New Brunswick, New Jersey, United States
• Capital Pediatrics & Adolescent Center PLLC — Raleigh, North Carolina, United States
• Capitol Pediatric & Adolescent Center PLLC — Raleigh, North Carolina, United States
• Dayton Clinical Research — Dayton, Ohio, United States
• Charleston Allergy & Asthma Research — Summerville, South Carolina, United States
• Holston Medical Group — Kingsport, Tennessee, United States
• TTS Research — Boerne, Texas, United States
• Allergy Asthma Research Institute — Waco, Texas, United States
• PI-Coor Clinical Research — Burke, Virginia, United States
• Advanced Pediatrics — Vienna, Virginia, United States

Full record on ClinicalTrials.gov

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