Who is sponsoring NCT02787967?

NCT02787967 is sponsored by Chiesi Farmaceutici S.p.A..

What drugs are being tested in NCT02787967?

Interventions: CHF 1535 35/4µg NEXThaler®, free comb. beclomethasone DPI and formoterol DPI.

What is the status of NCT02787967?

NCT02787967 is currently COMPLETED.

Last reviewed 2018-02-01 · How we verify

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

NCT02787967 Phase 2 COMPLETED

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

Details

Lead sponsor	Chiesi Farmaceutici S.p.A.
Phase	Phase 2
Status	COMPLETED
Enrolment	26
Start date	2016-08
Completion	2017-06

Conditions

Asthma

Interventions

CHF 1535 35/4µg NEXThaler®
free comb. beclomethasone DPI and formoterol DPI

Primary outcomes

Plasma Area Under Curve (AUC0-t) for B17MP, active metabolite of BDP — predose, 15,30min, 1,2,4,6,8 hours post dose
B17MP: Profile of Pharmacokinetics

Countries

Denmark