NCT01349257

Pharmacokinetic Clinical Study of CHF1535 NEXT DPI® Versus CHF1535 pMDI

Study Title: A Single-dose, Open-label, Randomised, 2-way Crossover, Clinical Pharmacology Study of Four Inhalations of CHF 1535 100/6 NEXT DPI® (Fixed Combination of Beclomethasone Diproponate 100 µg Plus Formoterol Fumarate 6 µg) Versus the Same Dose of CHF 1535 100/6 pMDI Both Administered With Charcoal Block.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The aim of this clinical study is to compare the lung exposure of the contents of the trial drug after administration of the fixed combination between beclomethasone and formoterol delivered via the new Chiesi dry powder inhaler in comparison to the beclomethasone and formoterol delivered via the pressurised metered dose inhaler (pMDI) using a spacer device. To determine lung exposure, the treatments are administered with charcoal block.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	BDP/Formoterol	One single day treatment of CHF 1535 100/6 NEXT DPI®: CHF 1535 dry powder for inhalation (fixed combination of beclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg per actuation) administered via the NEXT DPI® dry powder inhaler with charcoal block.

Timeline

• Start date: 2011-05-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2011-05-06
• Last updated: 2020-07-31

Locations

1 site across 1 country: United Kingdom