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

Phase 2 Completed 304 enrolled AstraZeneca

RandomizedParallel-groupQuadruple-blindTreatment

Summary

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

Timeline

Start: 2010-07
Primary completion: 2013-04
Completion: 2013-04

Outcome

Met primary endpoint

paper Budesonide treatment significantly improved morning PEF vs placebo; mean treatment effect (budesonide vs placebo) was 13.6 L/min (P < .0001). PMID 26460293 ↗

registry Placebo vs Budesonide; p <0.0001; LS mean difference 13.6 (95% CI 7.5 to 19.7) NCT01136382 ↗

Publications

Meltzer EO, Pearlman DS, Eckerwall G, Uryniak T, DePietro M, Lampl K. Efficacy and safety of budesonide administered by pressurized metered-dose inhaler in children with asthma. Ann Allergy Asthma Immunol. 2015 Dec;115(6):516-22. doi: 10.1016/j.anai.2015.09.007. Epub 2015 Oct 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Budesonide	Small molecule	160 ug	Other