PK of BDP/FF/GB Single-inhaler Triple Therapy in Japanese vs. Caucasians

PHASE1CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

March 18, 2019

Primary Completion Date

July 24, 2019

Study Completion Date

July 24, 2019

Conditions
AsthmaChronic Obstructive Pulmonary Disease
Interventions
DRUG

Therapeutic Dose 1

CHF 5993 100/6/12.5 µg pMDI, fixed combination of BDP 100 µg + FF 6 µg + GB 12.5 µg.

DRUG

Therapeutic Dose 2

CHF 5993 200/6/12.5 µg pMDI, fixed combination of BDP 200 µg + FF 6 µg + GB 12.5 µg.

DRUG

Supra-therapeutic Dose

CHF 5993 200/6/12.5 µg pMDI, fixed combination of BDP 200 µg + FF 6 µg + GB 12.5 µg.

DRUG

Placebo

CHF 5993 placebo pMDI

Trial Locations (1)

SW17 0RE

Richmond Pharmacology Ltd, London

All Listed Sponsors
lead

Chiesi Farmaceutici S.p.A.

INDUSTRY

NCT03859414 - PK of BDP/FF/GB Single-inhaler Triple Therapy in Japanese vs. Caucasians | Biotech Hunter | Biotech Hunter