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Clinical Trial Summary

The study is being conducted to compare the pharmacokinetic (PK) of BDP (and its main active metabolite B17MP), FF, and GB between CHF 5993 BDP/FF/GB 200/6/12.5 µg pMDI and CHF 5993 BDP/FF/GB 100/6/12.5 µg pMDI (pressurized Metered Dose Inhaler), to assess the proportionality of systemic exposure to BDP and B17MP (17-Monoproprionate), and the systemic exposure to FF and GB with increasing doses of BDP. The study includes a QVAR REDIHALER® arm too.


Clinical Trial Description

The main purpose of this study is to evaluate the systemic exposure to B17MP, FF, and GB as the area under the concentration-time curve from zero to time 't' where t is the last quantifiable time point (AUC0-t) and maximum plasma concentration (Cmax) across two different dose strengths of CHF 5993 BDP/FF/GB (200/6/12.5 μg and 100/6/12.5 μg). The secondary purposes of the study are: 1. To evaluate the pharmacokinetic profile of BDP and additional pharmacokinetic parameters of B17MP, FF, and GB across two different dose strengths of CHF 5993 BDP/FF/GB (200/6/12.5 μg and 100/6/12.5 μg); 2. To compare the exposure to BDP and B17MP between the high dose BDP/FF/GB (total daily dose [TDD]: 800/24/50 µg) and the highest US-approved dose of QVAR (TDD 800 µg). 3. generate additional safety and tolerability information of the two CHF 5993 pDMI strengths, after a single dose. Participation in the study will last for a maximum of 70 days for each subject (starting from randomization). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05898984
Study type Interventional
Source Chiesi Farmaceutici S.p.A.
Contact Chiesi clinical Trial Info
Phone +3950212791
Email clinicaltrials_info@chiesi.com
Status Recruiting
Phase Phase 1
Start date April 24, 2023
Completion date August 3, 2023

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