NCT05755932

Study to Assess Effect of Next-Generation Propellant MDI on Mucociliary Clearance Vs. HFA Propellant MDI in Healthy Participants

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

A Study to Assess the Effect of the HFO MDI Propellant on Mucociliary Clearance Compared to the HFA MDI Propellant in Healthy Participants

Detailed description

A randomized, double-blind, multi-site, two-way crossover study to assess the effect on MCC and safety of HFO propellant compared to HFA propellant in healthy participants. Mucociliary clearance will be determined after 1 week of twice daily (BID) administration of HFO MDI (test) and HFA MDI (reference). The study will comprise a Screening Period 7 to 14 days prior to first dosing; Two Treatment Periods (TPs) of 7 days each (+ up to 3 days), with a 7 to 14 day Washout Period between the 2 TPs; and a final safety Follow-up Visit 5 to 7 days after the final dose administration in TP2. Participants will receive treatments in 1 of 2 possible treatment sequences: A followed by B, or B followed by A. Study treatment will be administered via MDI device as 6 inhalations BID (every morning and evening approximately 12 hours apart): Treatment A: HFO MDI; 6 inhalations per dose - test formulation Treatment B: HFA MDI; 6 inhalations per dose - reference formulation

Conditions

• Mucociliary Clearance

Interventions

Type	Name	Description
DRUG	HFO-1234ze(E)	* Dose formulation: metered dose inhaler (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
DRUG	HFA-134a	* Dose formulation: metered dose inhaler (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.

Timeline

• Start date: 2023-06-14
• Primary completion: 2024-07-22
• Completion: 2024-07-22
• First posted: 2023-03-06
• Last updated: 2026-02-25

Locations

5 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated drug study