A 12-Week Study in Asthmatic Children Ages 6 to <12 Years, Investigating the Efficacy and Safety of Symbicort pMDI 80/2.25 μg and Symbicort pMDI 80/4.5 μg, Compared With Budesonide pMDI 80 μg

Completed · Phase 3

Conditions studied: Asthma

In brief

The purpose is to investigate the Efficacy and Safety of Symbicort pMDI 80/2.25 μg and Symbicort pMDI 80/4.5 μg, Compared with Budesonide pMDI 80 μg, 2 Actuations Twice Daily, in Children Ages 6 to \<12 Years with Asthma during 12 weeks.

Key facts

Study ID

NCT02091986

Run by

AstraZeneca

People needed

882

Starts

2014-04-01

Expected to finish

2016-04-01

Last updated by the study team

2017-04-10

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 defined by the ATS for at least 6 months prior to Visit 2
• Have a morning pre-bronchodilator clinic FEV1 measured at least 6 hours after the last dose of inhaled SABA and at least 48 hours after last dose of inhaled LABA of 60% to 100% of predicted normal
• Demonstrated reversibility of clinic FEV1 of ≥12% from pre -albuterol/salbutamol level within 15 to 30 minutes after administration of a standard dose of albuterol/salbutamol.

You may not qualify if…

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

Where it is running

• Research Site — Montgomery, Alabama, United States
• Research Site — Gilbert, Arizona, United States
• Research Site — Little Rock, Arkansas, United States
• Research Site — Huntington Beach, California, United States
• Research Site — Long Beach, California, United States
• Research Site — Mission Viejo, California, United States
• Research Site — Newport Beach, California, United States
• Research Site — Ontario, California, United States
• Research Site — Stockton, California, United States
• Research Site — Walnut Creek, California, United States
• Research Site — Colorado Springs, Colorado, United States
• Research Site — Denver, Colorado, United States
• Research Site — Aventura, Florida, United States
• Research Site — Coral Gables, Florida, United States
• Research Site — Fort Walton Beach, Florida, United States
• Research Site — Hialeah, Florida, United States
• Research Site — Homestead, Florida, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Largo, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Williston, Florida, United States
• Research Site — Winter Park, Florida, United States
• Research Site — Savannah, Georgia, United States
• Research Site — Stockbridge, Georgia, United States
• Research Site — Hoover, Alabama, United States

Full record on ClinicalTrials.gov

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