Comparison of the effects of 2 propellants in adults with mild asthma

• Research type

  Research Study

• Full title

  A single-dose, randomised, double-blind, controlled, 2-way cross-over study to assess the potential for bronchoconstriction of the new propellant HFA-152a versus the marketed HFA-134a propellant, in adult subjects with mild asthma.

• IRAS ID

  317394

• Contact name

  Dave Singh

• Contact email

  DSingh@meu.org.uk

• Sponsor organisation

  Chiesi Farmaceutici S.p.A.

• Clinicaltrials.gov Identifier

  NCT05472662

• Duration of Study in the UK

  0 years, 4 months, 10 days

• Research summary

  Summary of Research
  Asthma is frequently treated with inhaled metered doses of medications delivered via a pressurised inhalation device (pMDI). Such devices employ a liquified gas as a propellant to generate an aerosol cloud for inhalation. Ozone depleting effects of chlorofluorocarbons (CFCs) led to a switch in the 1990s to hydrofluoroalkane (HFA) propellants, including HFA-134a. There is growing concern, however, over the contribution to global warming of many HFAs, including HFA-134a. Like other manufacturers, Chiesi seeks to employ a more planet friendly propellant to replace those in current use. One such propellant is HFA-152a.

  This study is designed to compare the effects of a new propellant, HFA-152a, with a marketed propellant HFA-134a delivered via a pMDI and to find out if the new propellant might cause narrowing of the airways (bronchoconstriction). The safety and tolerability of HFA-152a will also be assessed.

  Twenty four adults with mild asthma will be included in this 2-way cross-over study, each inhaling large single doses (10 puffs within 12 minutes) of both of two treatments (i.e. propellant HFA-134a or HFA-152a only). The treatments will be separated by 2-7 days and administered in random order without either the participants or research staff knowing which treatment is administered first or second.

  The study is expected to last 6 weeks for each participant and involves 4 clinic visits: Pre-Screening (V0), Screening (V1), Treatment Period 1 (V2), Treatment Period 2 (V3) and a phone call 7- 10 days after V3.

  Safety and tolerability will be assessed from clinical laboratory and lung function tests, historical review of any symptoms, physical examination, vital signs, electrocardiograms, urinalysis and pregnancy tests in women of child bearing potential.

  Additionally, as an exploratory measure, a questionnaire will be used to enable participants to report the taste sensation after each treatment period.

  Summary of Results
  : A lay summary of results will be provided by October 2023

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  22/EM/0144

• Date of REC Opinion

  1 Jul 2022

• REC opinion

  Favourable Opinion