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

Summary

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.

Timeline

Start

2010-09

Primary completion

2011-12

Completion

2011-12

Outcome

Met primary endpoint

paper All formoterol doses showed significantly higher average 12-hour forced expiratory volume in 1 second (FEV1; area under the curve) versus placebo (primary efficacy). PMID 24717790 ↗

registry analysis (superiority or other test); BUD 160/FM 9.0 vs BUD 160; p <0.0001; LS mean difference 0.114 (95% CI 0.087 to 0.142); ANCOVA NCT01136655 ↗

Publications

• Berger WE, Gillen M, Eckerwall G, Uryniak T, Trudo FJ, Lampl KL. Bronchodilator effect of single-dose formoterol administered by pressurized metered-dose inhaler in children with asthma aged 6 to <12 years receiving budesonide. Allergy Asthma Proc. 2014 Mar-Apr;35(2):134-40. doi: 10.2500/aap.2014.35.3746.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Formoterol	Other / unclassified	2.25 ug	Inhaled
Subject	Formoterol	Other / unclassified	4.5 ug	Inhaled
Subject	Formoterol	Other / unclassified	9 ug	Inhaled
Subject	Formoterol	Other / unclassified	12 ug	Inhaled
Background	Budesonide	Small molecule	40 ug	Inhaled

Indications