Study identifier:D5985C00006
ClinicalTrials.gov identifier:NCT05755932
EudraCT identifier:N/A
CTIS identifier:N/A
A Randomized, Double-blind, Two-way Crossover Study to Assess the Effect of Hydrofluoroolefin (HFO) Propellant Metered Dose Inhaler (MDI) on Mucociliary Clearance Compared with Hydrofluoroalkane (HFA) Propellant MDI in Healthy Participants
Mucociliary Clearance
Phase 3
Yes
HFO MDI, HFA MDI
All
35
Interventional
18 Years - 60 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Basic Science
Verified 01 Jul 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Treatment A: HFO MDI Test arm, 6 inhalations BID for 7 days | Drug: HFO MDI - Dose formulation: MDI - Unit dose strength(s): Experimental (propellant only) - Dosage level(s): 6 inhalations, BID - Route of administration: Oral inhalation - Participants will receive treatment A in 1 of 2 possible treatment sequences: AB or BA Other Name: Propellant in MDI |
Active Comparator: Treatment B: HFA MDI Reference arm, 6 inhalations BID for 7 days | Drug: HFA MDI - Dose formulation: MDI - Unit dose strength(s): Reference (propellant only) - Dosage level(s): 6 inhalations, BID - Route of administration: Oral inhalation - Participants will receive treatment B in 1 of 2 possible treatment sequences: AB or BA. Other Name: Propellant in MDI |