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

NCT ID: NCT07301736

Last Updated: 2025-12-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 780 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-15
• Study Completion Date: 2027-06-03

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.

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

CHF5993 pMDI with HFA-152a

Intervention Type: DRUG

two puffs BID (twice daily)

Reference Treatment 1: CHF5993 pMDI with HFA-134a

BDP/FF/GB 100/6/12.5 µg

Group Type: ACTIVE_COMPARATOR

CHF5993 pMDI with HFA-134a

Intervention Type: DRUG

two puffs BID

Reference Treatment 2: CHF718 pMDI with HFA-134a

BDP 100 µg

Group Type: ACTIVE_COMPARATOR

CHF718 pMDI with HFA-134a

Intervention Type: DRUG

two puffs BID

Interventions

CHF5993 pMDI with HFA-152a

two puffs BID (twice daily)

Intervention Type: DRUG

CHF5993 pMDI with HFA-134a

two puffs BID

Intervention Type: DRUG

CHF718 pMDI with HFA-134a

two puffs BID

Intervention Type: DRUG

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chiesi Farmaceutici S.p.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Piotr KUNA, MD

Role: PRINCIPAL_INVESTIGATOR

Barlicki University Hospital Medical University of Lodz, Poland

Central Contacts

Chiesi Clinical Trial Info Chiesi Clinical Trials

Role: CONTACT

Phone: +39 0521 2791

Email: clinicaltrials_info@chiesi.com

Other Identifiers

2025-521456-35-00

Identifier Type: CTIS

Identifier Source: secondary_id

CLI-05993AA9-01

Identifier Type: -

Identifier Source: org_study_id