NCT05875025

Study to Assess the Effect of the New HFA-152a Propellant on Mucociliary Clearance

Open-label, Randomised, Controlled, 2-way Cross-over Study to Assess the Effect of Multiple Doses of the New HFA-152a Propellant Versus the Marketed HFA-134a Propellant on Mucociliary Clearance in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study was to assess the effect of multiple doses of the HFA-152a propellant and the HFA-134a propellant on mucociliary clearance (MCC).

Detailed description

This clinical trial was a Phase I, single-centre, multiple-dose, randomised, open-label, controlled, 2-way cross-over study to assess the effect on MCC of the new HFA-152a propellant (5 inhalations BID for 8 days) versus the marketed HFA-134a propellant (5 inhalations BID for 8 days) in adult healthy volunteers by measuring the clearance from the lungs of inhaled radioaerosol. A total of 20 subjects were randomised into the study. Standard safety assessments was conducted during the Study, including safety blood and urine laboratory tests, vital signs, physical examinations, ECGs, spirometry, and observations of any adverse events (AE).

Conditions

• Mucociliary Clearance

Interventions

Type	Name	Description
OTHER	Placebo formulated with HFA-152a propellant via pMDI	5 inhalations BID (morning and evening) for 8 consecutive days, starting from the morning of Day 1 until the morning of Day 8
OTHER	Placebo formulated with HFA-134a propellant via pMDI	5 inhalations BID (morning and evening) for 8 consecutive days, starting from the morning of Day 1 until the morning of Day 8

Timeline

• Start date: 2023-06-26
• Primary completion: 2023-09-08
• Completion: 2023-09-08
• First posted: 2023-05-25
• Last updated: 2024-11-12
• Results posted: 2024-11-12

Locations

1 site across 1 country: United Kingdom