Clinical Pharmacology of 35/4 NEXThaler® in Children 5-11 Years Old

Summary

The study will be conducted in asthmatic children aged 5 to 11 years and is based on a single-dose, open-label, randomized, 2-way cross-over design where a Dry Powder Inhaler (DPI) fixed combination of beclometasone dipropionate (BDP) 35 μg plus formoterol fumarate (FF) 4 μg is compared with the free combination of licensed BDP DPI and FF DPI

Timeline

Start

2016-08

Primary completion

2017-06

Completion

2017-06

Drugs

Indications