Therapeutic equivalence of CHF993 pMDI 1 00/6/12.5 uj HFA-152a in subjects with mild-moderate asthma
Research type
Research Study
Full title
A Phase II, multinational, multicentre, double-blind, randomised, active-controlled, 3-way cross-over study to evaluate the therapeutic equivalence of CHF5993 pMDI 100/6/12.5 μg HFA-152a versus CHF5993 pMDI 100/6/12.5 μg HFA-134a in subjects with mild to moderate asthma (TRECONY)
IRAS ID
1012890
Contact name
Clinical Project Manager Clinical Project Manager
Contact email
Sponsor organisation
Chiesi Farmaceutici S.p.A.
Research summary
This study is testing the medicine, called CHF5993, with a new propellant, in asthma. The inhaler uses an environmentally friendly gas (called HFA-152a) instead of the current propellant (HFA-134a). The aim is to assess whether the inhaler with the new propellant is as safe, efficient and well tolerated as the inhaler with the existing propellant, in patients with asthma.
Around 336 adults aged 18 to 75 (approx. 28 UK patients) with mild to moderate asthma will take part in this study at about 200 locations worldwide. The study lasts about 20 weeks and includes 8 visits.
If after hearing about the study, reading the Participant Information Sheet (PIS) & Informed Consent Form (ICF) and speaking to the study doctor patients decide to participate they will be asked to sign the ICF.
After consent, patient will be given placebo for 2 weeks. Then if patients are eligible they will be randomly assigned in a sequence to the following groups during 3 different period of 4 weeks each:
-CHF5993 with the new propellant gas (HFA-152a)
-CHF5993 with the existing propellant gas (HFA-134a)
-CHF718 with the existing propellant gas (HFA-134a): The CHF718 arm is defined as sensitivity arm. The sensitivity arm of a clinical trial is defined as the trial's ability to distinguish an effective treatment from a less effective or an ineffective one.This is a “cross-over” study, meaning all participants will receive each treatment in a different order. The study is double-blind, so neither participant nor the doctor will know which treatment is being received at any time.
Study procedures include: physical exams, ECGs, lung tests, blood/urine samples, questionnaires, and e-diaries.
Rescue medication (like salbutamol) can be utilised if needed. The doctor will explain everything clearly, including how and when to use each inhaler and instructions will be provided with each medication.
REC name
London - South East Research Ethics Committee
REC reference
25/LO/0748
Date of REC Opinion
30 Oct 2025
REC opinion
Further Information Favourable Opinion