A Study in Asthmatic Children (6 to <12 Yrs) Comparing Single Doses of Formoterol and Foradil® Evaluating Efficacy

Completed · Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

This purpose of the study is to investigate the bronchodilating effects of 3 different dosages of formoterol given in combination with budesonide as Symbicort pMDI.

Key facts

Study ID

NCT01136655

Run by

AstraZeneca

People needed

54

Starts

2010-09-01

Expected to finish

2011-12-01

Last updated by the study team

2013-10-31

Who can join

Age: 6 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has a documented clinical diagnosis of asthma for at least 6 months prior to Visit 1
• Has a FEV1 measured at least 6 hours after the last dose of inhaled, short-acting β2-agonist (SABA) and at least 48 hours after the last dose of inhaled long-acting β2-agonist of =60% and =85% of predicted normal.
• Demonstrated reversibility of FEV1 of =15% from pre short acting beta agonist level within 15 to 30 minutes after administration of a standard dose of short acting beta agonist

You may not qualify if…

• Has been hospitalized for >24 hours at least once or required emergency treatment or urgent care visit more than once for an asthma-related condition during the 6 months prior to Visit 1
• Has required treatment with systemic corticosteroids (eg, oral, parenteral, or rectal) for any reason within the 12 weeks prior to Visit 1.

Where it is running

• Research Site — Huntington, California, United States
• Research Site — Long Beach, California, United States
• Research Site — Mission Viejo, California, United States
• Research Site — Orange, California, United States
• Research Site — Rolling Hills Estate, California, United States
• Research Site — Sarasota, Florida, United States
• Research Site — Omaha, Nebraska, United States
• Research Site — Morrisville, North Carolina, United States
• Research Site — Raleigh, North Carolina, United States
• Research Site — Eugene, Oregon, United States
• Research Site — Lake Oswego, Oregon, United States
• Research Site — Medford, Oregon, United States
• Research Site — Portland, Oregon, United States
• Research Site — Altoona, Pennsylvania, United States
• Research Site — Upland, Pennsylvania, United States
• Research Site — Charleston, South Carolina, United States
• Research Site — El Paso, Texas, United States
• Research Site — San Antonio, Texas, United States
• Research Site — Waco, Texas, United States
• Research Site — Springfield, Virginia, United States
• Research Site — Dublin, Bulgaria
• Research Site — Dublin, Czechia
• Research Site — Budapest, Hungary
• Research Site — Dublin, Hungary
• Research Site — Miskolc, Hungary

Full record on ClinicalTrials.gov

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