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

Completed · Phase 2

Conditions studied: Asthma

In brief

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

Key facts

Study ID

NCT00583947

Run by

Sumitomo Pharma America, Inc.

People needed

53

Starts

2008-01-01

Expected to finish

2008-12-01

Last updated by the study team

2012-02-22

Who can join

Age: 2 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Beverly Hills, California, United States
• Study site — Orange, California, United States
• Study site — Savannah, Georgia, United States
• Study site — Normal, Illinois, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Medford, Oregon, United States
• Study site — Portland, Oregon, United States
• Study site — Upland, Pennsylvania, United States
• Study site — Orangeburg, South Carolina, United States
• Study site — Spartanburg, South Carolina, United States
• Study site — Dallas, Texas, United States
• Study site — Burke, Virginia, United States
• Study site — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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