A Safety and Tolerability Study of Arformoterol Tartrate Inhalation Solution in Pediatric Subjects

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine the safety and tolerability of Arformoterol Tartrate in children with asthma

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunovion
• Treatments: Albuterol; Formoterol Fumarate

Criteria

Inclusion Criteria:

• Male and Female

• Between Age 2 and 11, inclusive, at the time of consent

• Weight equal to or greater than 15 Kg

• History of physician-diagnosed asthma of at least 2 years duration for children age 6 and older, and at least 1 year duration for children 5 and younger.

Exclusion Criteria:

• Female subject who is pregnant or lactating.

• Subject who has a history of hospitalization for asthma within one year, or who is scheduled for in-patient hospitalization, including elective surgery during the course of the trial.

• Subject with any history of life-threatening asthma defined as a history of asthma episodes requiring intubation, associated with hypercapnia, respiratory arrest, or hypoxic seizures.

• Subject with a history of cancer.

• Subject with hyperthyroidism, diabetes, hypertension, cardiac diseases or seizure disorders.

• Subject with a history of cigarette smoking or use of any tobacco products.