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

NCT05755932 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-02-25

No results posted yet for this study

Summary

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

Conditions

  • Mucociliary Clearance

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • William D Bennett, PhD · University of North Carolina, Chapel Hill

  • Andreas Schmid, MD · University of Kansas Medical Center

  • Timothy Corcoran, PhD · UPMC Montefiore Hospital

  • Peter Mogayzel, MD, PhD, MBA · Johns Hopkins University

  • Douglas Conrad, MD · University of California, San Diego

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-14
Primary Completion
2024-07-22
Completion
2024-07-22
FDA Drug
Yes

Countries

  • United States
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05755932 on ClinicalTrials.gov