Overview

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.