The effect of a new HFA-152a propellant on normal lung clearance

• Research type

  Research Study

• Full title

  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.

• IRAS ID

  326075

• Contact name

  Rory Taylor

• Sponsor organisation

  Chiesi Farmaceutici S.p.A

• Clinicaltrials.gov Identifier

  2022-003247-97, EudraCT

• Duration of Study in the UK

  0 years, 4 months, 30 days

• Research summary

  This study has been designed to assess the effect of multiple doses of the new propellant (HFA-152a)within an inhaler HFA-152a versus the marketed propellant (HFA-134a) in a currently marketed inhaler device on mucociliary clearance (the ability to clear the lungs through the use of mucus and cilia) in healthy volunteers.

  Each subject will be administered multiple doses (5 inhalations twice daily [BID] for 8 consecutive days) of each of the two following treatments

  • Test treatment: placebo HFA-152a propellant pMDI;
  • Reference treatment: placebo HFA 134a propellant pMDI.

  The administration of the study treatment will occur using two pressurised metered dose inhalers (pMDI) (one for each of the two treatment periods) for each subject. Each subject will complete two 8-day treatment periods, each including an 8-day treatment administration. The two treatment periods will be separated by a 7 to 14 day wash out period.

  The study will be conducted in up to 20 adult male and female healthy volunteers, aged 18 to 55 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, subjects 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.

  Subjects will be required to attend the study unit on up to seven occasions and will take the study treatment at home during the 8 day treatment period. Except from the first and last dose for each treatment periods that will be administered at the clinic.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  23/SC/0107

• Date of REC Opinion

  20 Apr 2023

• REC opinion

  Favourable Opinion