NCT01370031

Pilot Pharmacokinetic Clenil Study With AeroChamber Plus™ or Volumatic™ Spacer Devices

Pilot, Open-Label, Randomized, Repeated Dose, 4-Way Cross-Over, Clinical Pharmacology Study of Beclomethasone Dipropionate (Clenil® Modulite®) 250 µg HFA pMDI Using the Aerochamber Plus™ Spacer Device Versus the Volumatic™ Spacer Device Without or With Charcoal Block in Asthmatic Adults Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate, at steady-state, the systemic exposure and the lung deposition of B17MP (active metabolite of BDP) as AUC0-12h,ss and Cmax,ss, after inhalation of BDP (Clenil® Modulite®) with the AeroChamber Plus™ spacer device or with the Volumatic™ spacer device without or with charcoal block.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Clenil® Modulite® via AeroChamber Plus™	Clenil® Modulite® 250 µg via AeroChamber Plus™ spacer during 14 days
DRUG	Clenil® Modulite® via Volumatic™ spacer	Clenil® Modulite® 250 µg via Volumatic™ spacer during 14 days
DRUG	Clenil® Modulite® via AeroChamber Plus™ plus charcoal block	Clenil® Modulite® via AeroChamber Plus™ spacer during 14 days (plus charcoal block at Day 14)
DRUG	Clenil® Modulite® administered via Volumatic™ spacer plus charcoal block	Clenil® Modulite® administered via Volumatic™ spacer during 14 days (plus charcoal block at day 14)

Timeline

• Start date: 2011-04-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2011-06-09
• Last updated: 2017-03-30

Locations

1 site across 1 country: United Kingdom