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

• Status: Terminated
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunovion
• Treatments: Albuterol

Criteria

Inclusion Criteria:

1. 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.

2. Subject experiencing acute bronchospasm requiring a bronchodilator and who have a history of wheezing.

Exclusion Criteria:

1. Subject with a severe illness that, in the opinion of the Investigator, could jeopardize subject safety.

2. 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.

3. Subject received ipratropium within 4 hours prior to ED or physician's office admittance.

4. Subject who participated in an investigational drug study within 30 days prior to enrollment, or who previously participated in the current study.

5. Subject with a known sensitivity to levalbuterol or racemic albuterol or any of the excipients contained in any of these formulations.

6. Subject using any prescription drug (including beta-blockers) with which levalbuterol or racemic albuterol sulfate administration is contraindicated.

7. 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).

8. Subject with a history of cancer.