Respiratory
Conditions
Interventions
CHF5993 pMDI HFA 152a
CHF5993 pMDI HFA 134a
CHF718 pMDI HFA 134a
Sponsors
Chiesi Farmaceutici S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent: obtained prior to any study-related procedure; 2. Sex and age: male and female adults aged =18 and =75 years; 3. Body mass index: within the range of 18.0 to 35.0 kg/m2 inclusive; 4. Smoking status: non-smokers or ex-smokers who smoked =10 pack-years (pack-years = the number of cigarette packs per day x the number of years) and stopped smoking >1 year (6 months for e-cigarettes) prior to screening; 5. Diagnosis of asthma: documented physician-diagnosed asthma for at least 6 months prior to screening and with diagnosis before the age of 50 years; 6. Stable asthma therapy: a stable maintenance treatment for at least 4 weeks prior to screening with: a. low or medium doses of ICS alone; or b. low or medium doses of ICS + LABA (fixed or free combination). 7.Asthma control: controlled or partly controlled based on an Asthma Control Questionnaire - 7 Items (ACQ-7) score 40% and 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). 10. Rescue medication: subjects must be able to replace their current rescue medication with a salbutamol (i.e. albuterol) inhaler for use as needed for the duration of the study. Subjects should be able to withhold short-acting ß2-agonist (SABA) use for at least 6 h prior to lung function assessments during study visits; 11. Current therapy: subjects must be able to safely discontinue their asthma medications (ICS with or without LABA) during the run-in period and for the remainder of the study; 12. Spacer non-use: subjects must be able to inhale the study treatment without using a spacer;
Exclusion criteria
Exclusion criteria: 1. History of high-risk asthma: 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; 2. Recent asthma exacerbation: 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 (to be checked again at randomisation); 3. Non-persistent asthma: exercise-induced, seasonal asthma (as the only asthma-related diagnosis) not requiring daily asthma control medicine; 4. Asthma subjects currently treated with any of the following (to be re-checked at randomisation).: a. High dose ICS; b. Long-acting muscarinic antagonist (LAMA); c. Systemic, depot or slow-release corticosteroids within 12 weeks prior to screening; d. Any other asthma treatments (e.g. cromolyn sodium, nedocromil sodium, leukotriene modifiers) within 4 weeks prior to screening; e. Any biologic therapy (e.g. omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, tezepelumab) within 6 months prior to screening; 5. Respiratory disorders other than asthma any concomitant respiratory disorder other than asthma that, in the opinion of the Investigator and/or Medical Monitor, will interfere with the evaluation of the investigational medicinal product (IMP) or interpretation of subject safety or study results. This can include but is not limited to, diagnosis of chronic obstructive pulmonary disease as defined by the current guidelines (e.g. Global Initiative for Chronic Obstructive Lung Disease 2024 guidelines), known alpha-1 antitrypsin deficiency, active tuberculosis, bronchiectasis, sarcoidosis, pulmonary hypertension and interstitial lung disease/pulmonary fibrosis. 6. Lung resection:subjects with a history of lobectomy, pneumonectomy or other sizable lung volume resection(>25% removed).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate the therapeutic equivalence of CHF5993 pMDI HFA-152a versus (vs.) CHF5993 pMDI HFA-134a in terms of change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve from time zero to 4 hours (h) (AUC0-4h) on Day 1 and in pre-dose FEV1 on Day 28 in adults with mild to moderate, controlled/partly controlled asthma. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability profile of the study treatments in adults with mild to moderate, controlled/partly controlled asthma. | — |
Countries
South Africa
Contacts
Public ContactSuzaan Sirrals
Snr Clinical Operations Manager
Outcome results
None listed