NCT05898984

Clinical Study to Evaluate the Safety, Tolerability and the Concentration of the BDP (Beclomethasone Dipropionate), Active Metabolite of BDP, FF( Formoterol Fumarate) and GB (Glycopyrronium Bromide), After Inhalation of CHF 5993 at Two Different Doses and QVAR®

A Single Dose, Randomized, Open-label, 3-Way Cross-over Clinical Pharmacology Study, to Evaluate the Systemic Exposure of BDP, Beclomethasone 17-monoproprionate, Formoterol Fumarate, and Glycopyrronium Bromide, After Inhalation of the Fixed Combination BDP/FF/GB HFA pMDI (CHF 5993) at Two Different Strengths and of BDP Hydrofluoroalkane (HFA), in Healthy Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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).

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Test product (T):CHF 5993 BDP/FF/GB 200/6/12.5 µg pMDI	CHF 5993 BDP/FF/GB 200/6/12.5 µg pMDI with HFA 134a propellant (fixed combination of BDP \[200 μg\], FF \[6 μg\] and GB \[12.5 μg\] via pMDI): 4 inhalations alternated with 4 inhalations of CHF 5993 placebo, corresponding to 8 inhalations in total and giving a total daily dose (TDD) of BDP/FF/GB: 800/24/50 µg. Reference product 1 (R1): CHF 5993 BDP/FF/GB 100/6/12.5 µg pMDI with HFA 134a propellant (fixed combination of BDP \[100 μg\], FF \[6 μg\] and GB \[12.5 μg\] via pMDI): 4 inhalations alternated with 4 inhalations of CHF 5993 placebo, corresponding to 8 inhalations in total and giving a TDD of BDP/FF/GB: 400/24/50 µg. Reference product 2 (R2): BDP HFA (QVAR REDIHALER®, BDP 80 μg): pressurised, breath-actuated, metered dose aerosol with a dose counter): 8 inhalations (TDD of BDP: 640 µg ex-actuator, 800 µg ex valve).
DRUG	Reference product 1 (R1): CHF 5993 BDP/FF/GB 100/6/12.5 µg pMDI	with HFA 134a propellant (fixed combination of BDP \[100 μg\], FF \[6 μg\] and GB \[12.5 μg\] via pMDI): 4 inhalations alternated with 4 inhalations of CHF 5993 placebo, corresponding to 8 inhalations in total and giving a TDD of BDP/FF/GB: 400/24/50 µg
DRUG	Reference product 2 (R2): BDP HFA (QVAR REDIHALER®, BDP 80 μg)	pressurised, breath-actuated, metered dose aerosol with a dose counter): 8 inhalations (TDD of BDP: 640 µg ex-actuator, 800 µg ex valve).

Timeline

• Start date: 2023-04-24
• Primary completion: 2023-07-14
• Completion: 2023-07-14
• First posted: 2023-06-12
• Last updated: 2024-10-31

Locations

1 site across 1 country: Belgium