Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-24 @ 9:32 PM
NCT ID:
NCT05755932
Brief 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
Study:
NCT05755932
Study Brief:
Protocol Section:
NCT05755932