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

NCT07301736 | Recruiting Phase 2

• 2 other identifiers: CLI-05993AA9-012025-521456-35-00
• Study Type: interventional
• Target: 780
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Test Treatment: CHF5993 pMDI (Pressurised Metered Dose Inhaler) with HFA-152a

EXPERIMENTAL

BDP (Beclometasone Dipropionate)/FF (Formoterol Fumarate)/GB (Glycopyrronium Bromide) 100/6/12.5 µg

Drug: CHF5993 pMDI with HFA-152a

Reference Treatment 1: CHF5993 pMDI with HFA-134a

ACTIVE COMPARATOR

BDP/FF/GB 100/6/12.5 µg

Drug: CHF5993 pMDI with HFA-134a

Reference Treatment 2: CHF718 pMDI with HFA-134a

ACTIVE COMPARATOR

BDP 100 µg

Drug: CHF718 pMDI with HFA-134a

Interventions

CHF5993 pMDI with HFA-152a DRUG

two puffs BID (twice daily)

Test Treatment: CHF5993 pMDI (Pressurised Metered Dose Inhaler) with HFA-152a

CHF5993 pMDI with HFA-134a DRUG

two puffs BID

Reference Treatment 1: CHF5993 pMDI with HFA-134a

CHF718 pMDI with HFA-134a DRUG

two puffs BID

Reference Treatment 2: CHF718 pMDI with HFA-134a

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• low or medium doses of ICS (Inhaled Corticosteroids) alone; or
• 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).

You may not qualify if:

• 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 :
• High dose ICS;
• Long-acting muscarinic antagonist (LAMA);
• Systemic, depot or slow-release corticosteroids within 12 weeks prior to screening;
• Any other asthma treatments (e.g. cromolyn sodium, nedocromil sodium, leukotriene modifiers) within 4 weeks prior to screening;
• 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;

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (1)

Elpida Trials - Parloes Hub

Dagenham, RM9 5QP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Asthma

Interventions

norflurane

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Piotr KUNA, MD

  Barlicki University Hospital Medical University of Lodz, Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chiesi Clinical Trial Info Chiesi Clinical Trials

CONTACT

+39 0521 2791; clinicaltrials_info@chiesi.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 24, 2025
• Study Start: December 17, 2025
• Primary Completion (Estimated): June 3, 2027
• Study Completion (Estimated): June 3, 2027
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)