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A single dose, randomised, double blind, double dummy, placebo-controlled, three-period crossover clinical study, comparing the efficacy, safety and tolerability of Formoterol-HFA pMDI 12 microgram p...

Mise à jour : Il y a 4 ans
Référence : EUCTR2006-000907-41

A single dose, randomised, double blind, double dummy, placebo-controlled, three-period crossover clinical study, comparing the efficacy, safety and tolerability of Formoterol-HFA pMDI 12 microgram per actuation administered by means of a "spacer" device (AeroChamber Plus) with that of Formoterol-HFA pMDI 12 microgram per actuation in 5- to 12-year-old children with persistent moderate to severe asthma

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Extrait

The objective of this study is to demonstrate that Formoterol-HFA pMDI 12 µg with spacer (AeroChamber Plus) is clinically equivalent in terms of efficacy to Formoterol-HFA pMDI following a single dose administration in 5- to 12-year-old children with persistent moderate to severe asthma

Critère d'inclusion

  • Persistent moderate to severe childhood asthma (5 to 12 years of age, inclusive)

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