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

A vizsgálat adatai

Ki végzi

Chiesi Farmaceutici S.p.A.

Azonosító

NCT07301736EU 2025-521456-35-00

A regiszteradat frissítve

2026. június 25.

Eredeti leírás

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.A teljes eredeti leírásKevesebb

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.

Bevonási feltételek: 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).

Kizáró feltételek: 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 ; Lung resection; Respiratory disorders other than asthma; 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; 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; Non-persistent asthma: exercise-induced, seasonal asthma (as the only asthma-related diagnosis) not requiring daily asthma control medicine; Run-in compliance: e-Diary completion <75% and run-in treatment compliance <75% at randomisation.

ClinicalTrials.gov NCT07301736 · EU CTIS 2025-521456-35-00