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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Clenil® Modulite® 250 µg via AeroChamber Plus™ spacer during 14 days
Clenil® Modulite® 250 µg via Volumatic™ spacer during 14 days
Clenil® Modulite® via AeroChamber Plus™ spacer during 14 days (plus charcoal block at Day 14)
Medicines Evaluation Unit, Wythenshawe Hospital
Manchester, United Kingdom
Systemic exposure to B17MP (active metabolite of BDP) at steady state after repeated dose of Clenil® Modulite®
Plasma AUC0-12h,ss for B17MP
Time frame: 0-12 hours
Systemic exposure to B17MP (active metabolite of BDP) at steady state after repeated dose of Clenil® Modulite®
Plasma Cmax,ss for B17MP
Time frame: 0-12 hours
evaluation of the pharmacokinetic profile of BDP
AUC and Cmax for BDP
Time frame: 0-12 hours
Vital signs assessment
Heart rate and Blood pressure assessment
Time frame: from screening (week -1) to week 8
haematology and blood chemistry assessment
haematology and blood chemistry assessment
Time frame: at screening (week - 1) and week 8
Number of patients with Adverse events
Adverse events
Time frame: during the 11 weeks of study
FEV1 predose assessment
FEV1 predose assessment as lung function parameter
Time frame: from screening (week-1) to week 8
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Clenil® Modulite® administered via Volumatic™ spacer during 14 days (plus charcoal block at day 14)