A 6-week Study in Asthmatic Children Aged 6 to <12 Yrs Comparing Budesonide pMDI 160ug Twice Daily With Placebo

Completed · Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

This purpose of the study is to investigate if budesonide pMDI 160 �g twice a day during 6 weeks is effective and safe in treating asthmatic children aged 6 to \<12 years

Key facts

Study ID

NCT01136382

Run by

AstraZeneca

People needed

304

Starts

2010-07-01

Expected to finish

2013-04-01

Last updated by the study team

2014-08-01

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 2 that has required daily inhaled corticosteroid in the low dose range OR LTRA as monotherapy for at least 30 days prior to Visit 2.
• Has a morning clinic pre-bronchodilator FEV1 measured at least 6 hours after the last dose of inhaled short acting beta agonist of greater than or equal to 70% and less than or equal to 95% of predicted normal
• Demonstrated reversibility of FEV1 of ≥12% from pre short acting beta agonist level within 15 to 30 minutes after administration of a standard dose of short acting beta agonist OR has a documented reversibility of ≥ 12 % within 12 months prior to Visit 2.

You may not qualify if…

• Has been hospitalized at least once or required emergency treatment (was seen in the emergency room or had an urgent care visit) more than once for an asthma-related condition during the 6 months prior to Visit 2
• Has required treatment with systemic corticosteroids (eg, oral, parenteral, or rectal) for any reason within the 12 weeks prior to Visit 2

Where it is running

• Research Site — Fresno, California, United States
• Research Site — Granada Hills, California, United States
• Research Site — Huntington Beach, California, United States
• Research Site — Mission Viejo, California, United States
• Research Site — Orange, California, United States
• Research Site — Palmdal, California, United States
• Research Site — Rolling Hills Estate, California, United States
• Research Site — San Diego, California, United States
• Research Site — Stockton, California, United States
• Research Site — Centennial, Colorado, United States
• Research Site — Colorado Springs, Colorado, United States
• Research Site — Denver, Colorado, United States
• Research Site — Coral Gables, Florida, United States
• Research Site — Orange City, Florida, United States
• Research Site — Sarasota, Florida, United States
• Research Site — Albany, Georgia, United States
• Research Site — Gainesville, Georgia, United States
• Research Site — Normal, Illinois, United States
• Research Site — Overland Park, Kansas, United States
• Research Site — Bethesda, Maryland, United States
• Research Site — North Dartmouth, Massachusetts, United States
• Research Site — Ypsilanti, Michigan, United States
• Research Site — Plymouth, Minnesota, United States
• Research Site — Columbia, Missouri, United States
• Research Site — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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