The effect of a HFO propellant MDI inhaler on lung clearance

  • Research type

    Research Study

  • Full 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

  • IRAS ID

    340410

  • Contact name

    Lyn Corry

  • Contact email

    lyn.corry@bddpharma.com

  • Sponsor organisation

    Aztrazeneca

  • Clinicaltrials.gov Identifier

    NCT05755932

  • Duration of Study in the UK

    0 years, 2 months, 17 days

  • Research summary

    This study has been designed to assess the effect on Mucociliary clearance (the ability to clear the lungs through the use of mucus and cilia) and safety of HFO (hydrofluoroolefin) propellant compared to a HFA (hydrofluoroalkane) propellant within an inhaler in healthy participants.

    There will be two treatment periods of 7 days each with a 7-14 day washout period between the 2 treatment periods and a safety follow up visit 5-7 days after the final dose administration.

    The following treatments will be administered during the study:
    Treatment A: HFO Meter Dose Inhaler; 6 inhalations per dose - test formulation
    Treatment B: HFA Meter Dose Inhaler; 6 inhalations per dose - reference formulation

    Participants will be randomized to sequence.

    This multicentre study will be conducted in up to 30 adult male and female healthy volunteers, aged 18 to 60 years old. In this study we will use scinitigraphic imaging to assess the effect of the propellant on mucociliary clearance. To look at this parameter, participants will inhale particles which contain a small amount of radiation. The amount of radiation which reaches the lungs and how quickly it is cleared away will be calculated using the scintigraphic images.

    Prior to commencement of this study at the BDD site a qualification procedure will be conducted to demonstrate the ability of the BDD site to conduct the study procedures and collect the quality of research data required using the standardised procedure set out for this study. This will involve enrolment of 1 -3 healthy participant who will inhale radiolabel particles (99mTc) (no treatment will be administered).

    The images obtained from the qualification procedure will be submitted to a central reading site (University of North Carolina) for review and confirmation of acceptability.

  • REC name

    West of Scotland REC 5

  • REC reference

    24/WS/0037

  • Date of REC Opinion

    15 Apr 2024

  • REC opinion

    Further Information Favourable Opinion