NCT01848769

Clinical Pharmacology Study of CHF1535 pMDI 50/6 µg Versus The Free Combination In Asthmatic Children 5-11 Years Old

A Single-dose, Open-Label, 2-Way Cross-Over, Clinical Pharmacology Study Of Chf 1535 50/6 HFA pMDI (Fixed Combination Of Beclomethasone Dipropionate 50µg Plus Formoterol Fumarate 6 µg) Using The Aerochamber Plus™ Spacer Device Versus The Free Combination Of Beclomethasone HFA pMDI And Formoterol HFA pMDI Available On The Market Using The Aerochamber Plus™ Spacer Device In Asthmatic Children

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 5 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

The rationale is to investigate the systemic availability of BDP/B17MP and formoterol after single oral inhalation of CHF 1535 50/6 pMDI vs the free combination of approved BDP and Formoterol pMDIs, in asthmatic children (5 to 11 years old).

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	CHF1535 pMDI + AC Plus	Four inhalations for a total dose of BDP/FF 200/24 mcg
DRUG	BDP + AC Plus	Four inhalations for a total dose of BDP 200 mcg
DRUG	Formoterol + AC Plus	Four inhalations for a total dose of Formoterol 24 mcg

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2013-05-07
• Last updated: 2020-07-31

Locations

1 site across 1 country: Denmark