NCT02787967

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

A Single-dose, Open-label, Randomized, 2-way Cross-over Study of CHF 1535 35/4 NEXThaler® (Fixed Combination of Beclometasone Dipropionate (BDP) 35 μg Plus Formoterol Fumarate (FF) 4 μg Versus the Free Combination of Licensed BDP DPI (Dry Powder Inhaler) and FF DPI in Asthmatic Children

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 5 Years – 11 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is a pharmacokinetic comparison of NEXThaler 35/4 μg versus the free combination of Beclomethasone DPI and Formoterol DPI in children (5 to 11 years old) of a formulation already approved in adults.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	CHF 1535 35/4µg NEXThaler®	4 (four) inhalations (total dose: BDP/FF 140/16 µg)
DRUG	free comb. beclomethasone DPI and formoterol DPI	2 (two) inhalations BDP 100 µg DPI + 4 (four) inhalations FF 6 µg DPI (total dose: BDP 200 µg + FF 24 µg

Timeline

• Start date: 2016-08-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2016-06-02
• Last updated: 2018-02-05

Locations

1 site across 1 country: Denmark