Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-24 @ 9:32 PM
Study NCT ID:
NCT05755932
Status:
COMPLETED
Last Update Posted:
2025-07-31
First Post:
2023-02-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Assess Effect of Next-Generation Propellant MDI on Mucociliary Clearance Vs. HFA Propellant MDI in Healthy Participants
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: