Therapeutic Equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a in Subjects With Mild to Moderate Asthma (TRECONY)

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

This study will compare an asthma inhaler that uses a new climate friendly alternative propellant to an asthma inhaler with an existing propellant. We want to make sure both versions of the inhaler work the same way for people with mild to moderate asthma.

Study Overview

• Status: Recruiting
• Conditions: Asthma
• Intervention / Treatment: Drug: CHF5993 pMDI with HFA-152a; Drug: CHF5993 pMDI with HFA-134a; Drug: CHF718 pMDI with HFA-134a

Detailed Description

This global study aims to compare whether the investigational inhaler with the new HFA-152a propellant is as safe, effective and well tolerated in patients with asthma as the inhalers that use the existing HFA-134a propellant. HFA-152a is a propellant gas that is designed to have a lower global warming potential and to be more climate friendly. The study will be conducted in Europe, Latin America, Ukraine, South Africa and United Kingdom. It is planned to randomize 468 patients.

• Study Type: Interventional
• Enrollment (Estimated): 780
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Chiesi Clinical Trial Info Chiesi Clinical Trials; Phone Number: +39 0521 2791; Email: clinicaltrials_info@chiesi.com

Study Locations

• United Kingdom
  • Dagenham, United Kingdom, RM9 5QP
    • Recruiting
    • Elpida Trials - Parloes Hub
    • Contact: Ravali Goriparthi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male and female adults (18 ≤ age ≤ 75 years) with a diagnosis of Asthma for at least 6 months prior to screening and with diagnosis before the age of 50 years;
• Non-smokers, ex-smokers;
• Body mass index: within the range of 18.0 to 35.0 kg/m2 inclusive;

• Stable asthma therapy: a stable maintenance treatment for at least 4 weeks prior to screening with:

  1. low or medium doses of ICS (Inhaled Corticosteroids) alone; or
  2. low or medium doses of ICS + LABA (Long-acting β2-agonist) (fixed or free combination).
• Controlled or partly controlled based on an Asthma Control Questionnaire - 7 Items (ACQ-7) score <1.5 at screening and at randomisation.
• Pre-BD (Bronchodilator) FEV1 >40% and <90% of the predicted normal value, after appropriate wash out from BDs, at the Screening Visit (V1).
• A demonstrated increase in either FEV1 or forced vital capacity of >12% and >200 mL from baseline within 30 minutes (min) after inhalation of 400 µg salbutamol (i.e. albuterol) pMDI at the Screening Visit (V1).

Exclusion Criteria:

• History of near fatal asthma or hospitalisation for asthma in intensive care unit, inpatient setting or emergency room access for asthma in the previous 6 months prior to screening, which in the judgement of the Investigator may place the subjects at undue risk;
• Recent asthma exacerbation requiring systemic corticosteroids (SCSs), or emergency room admission or hospitalisation within 3 months prior to screening and/or during the run-in period ;
• Non-persistent asthma: exercise-induced, seasonal asthma (as the only asthma-related diagnosis) not requiring daily asthma control medicine;

• Asthma subjects currently treated with any of the following :

  1. High dose ICS;
  2. Long-acting muscarinic antagonist (LAMA);
  3. Systemic, depot or slow-release corticosteroids within 12 weeks prior to screening;
  4. Any other asthma treatments (e.g. cromolyn sodium, nedocromil sodium, leukotriene modifiers) within 4 weeks prior to screening;
  5. Any biologic therapy (e.g. omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, tezepelumab) within 6 months prior to screening;
• Respiratory disorders other than asthma
• Lung resection;
• Lower respiratory tract infection;
• Lung cancer and history of lung cancer;
• Subjects with active cancer or a history of cancer (other than lungs) ;
• Patients who have clinically significant cardiovascular condition;
• Run-in compliance: e-Diary completion <75% and run-in treatment compliance <75% at randomisation;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Treatment: CHF5993 pMDI (Pressurised Metered Dose Inhaler) with HFA-152a; BDP (Beclometasone Dipropionate)/FF (Formoterol Fumarate)/GB (Glycopyrronium Bromide) 100/6/12.5 µg	Drug: CHF5993 pMDI with HFA-152a; two puffs BID (twice daily)
Active Comparator: Reference Treatment 1: CHF5993 pMDI with HFA-134a; BDP/FF/GB 100/6/12.5 µg	Drug: CHF5993 pMDI with HFA-134a; two puffs BID
Active Comparator: Reference Treatment 2: CHF718 pMDI with HFA-134a; BDP 100 µg	Drug: CHF718 pMDI with HFA-134a; two puffs BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve from time zero to 4 hours (AUC0-4h) on Day 1	Day 1
Change from baseline in pre-dose FEV1 on Day 28	Day 28

Collaborators and Investigators

• Sponsor: Chiesi Farmaceutici S.p.A.
• Investigators: Principal Investigator: Piotr KUNA, MD, Barlicki University Hospital Medical University of Lodz, Poland

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2025
• Primary Completion (Estimated): June 3, 2027
• Study Completion (Estimated): June 3, 2027

Study Registration Dates

• First Submitted: December 11, 2025
• First Submitted That Met QC Criteria: December 11, 2025
• First Posted (Estimated): December 24, 2025

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma; norflurane
• Other Study ID Numbers: CLI-05993AA9-01; 2025-521456-35-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No