A Study Testing the Superiority of CHF 1535 pMDI 800/24µg Total Daily Dose Compared to CHF 718 pMDI 800µg Total Daily Dose in Adults With Asthma on Medium or High-Dose Inhaled Corticosteroid

Inclusion Criteria:

1. Informed consent: A signed and dated written informed consent obtained prior to anystudy-related procedures.

2. Sex and age: Male or female aged ≥18 and ≤75 years.

3. Diagnosis of asthma: A documented history of asthma for at least 1 year, with onsetbefore age 40

4. Stable asthma therapy: Use of medium-dose ICS with or without a LABA or high-doseICS alone for 3 months (at a stable dose for at least 4 weeks prior to screening).

5. Lung function: Subjects with a pre-bronchodilator FEV1 ≥40% and ≤85% of predicted,after appropriate washout from bronchodilators, at the screening and randomizationvisits. In addition, the absolute value of the first pre-dose FEV1 at randomization (V2) must be at least 80% of the pre-bronchodilator value attained at screening.

6. Reversibility post-bronchodilator: Subjects with a positive reversibility tobronchodilator at screening, defined as an increase in FEV1 > 12% and > 200mLcompared to baseline within 30 minutes after 4 inhalations of albuterol HFA pMDI 90µg/actuation. Note for IC#5 and IC#6: In case the reversibility and/or quality threshold is notmet at screening, the test can be performed once before randomization.

7. Female subjects: a. WOCBP fulfilling one of the following criteria: i. WOCBP with fertile malepartners: they and/or their partner must be willing to use a highly effective birthcontrol method from the signing of the informed consent form and until the follow-upcontact or ii. WOCBP with non-fertile male partners (contraception is not requiredin this case). b. Female subjects of non-childbearing potential defined as physiologicallyincapable of becoming pregnant (i.e. post-menopausal or permanently sterile as perdefinitions given in Appendix 2). Tubal ligation or partial surgical interventionsare not acceptable. If indicated, as per investigator's request, post-menopausalstatus may be confirmed by follicle-stimulating hormone levels (according to locallaboratory ranges).

8. Cooperative attitude and ability to demonstrate correct use of the pMDI inhalers andeDiary/peak flow meter.

Exclusion Criteria:

1. Pregnancy or lactation: where pregnancy is defined as the state of a female afterconception and until termination of the gestation, confirmed by a positive pregnancytest (serum and urine pregnancy test to be performed at screening visit and urinepregnancy test to be performed prior to randomization).

2. Poor compliance with run-in medication or eDiary completion <50% beforerandomization.

3. History of "at risk" asthma: History of near-fatal asthma or of a pasthospitalization for asthma in intensive care unit which, in the judgement of theinvestigator, may place the subject at undue risk.

4. Recent asthma exacerbation: Hospitalization, emergency room admission or use ofsystemic corticosteroids for an asthma exacerbation in the 4 weeks prior toscreening visit or during the run-in period.

5. Unresolved respiratory tract infection (RTI) in the 4 weeks prior to the screeningvisit or during run-in period. Documented coronavirus disease 2019 (COVID-19)diagnosis within the last 8 weeks or complications from this disease, which have notresolved within 14 days prior to screening.

6. Unstable ICS dose during the 4 weeks prior to screening visit, including any changein dose, schedule, or formulation.

7. Use of systemic corticosteroid medication in the 4 weeks prior to screening orslow-release corticosteroids in the 12 weeks before screening.

8. Respiratory disorders other than asthma: History of a diagnosis of cystic fibrosis,bronchiectasis, COPD (as defined by the current GOLD Report), alpha-1 antitrypsindeficiency, or any other significant lung disease which may interfere with studyevaluations.

9. Smoking status: Current smokers or ex-smokers with total cumulative exposure equalto or more than 10 pack-years or having stopped smoking within one year prior toscreening visit.

10. E-cigarette status: Current e-cigarettes users at the time of the screening visit.

11. Cannabis usage: Current use of inhaled or oral cannabis products (e.g. marijuana).

12. Substance abuse: Subjects with a history of alcohol or substance/drug abuse within 12 months prior to screening.

13. Cardiovascular diseases: Subjects who have clinically significant cardiovascularcondition such as, but not limited to, unstable ischemic heart disease, NYHA ClassIII/IV heart failure, acute ischemic heart disease within one year prior to studyentry, known history of atrial fibrillation or history of sustained andnon-sustained cardiac arrhythmias diagnosed within the last 6 months prior toscreening, not controlled with a rate control strategy. Note: Subjects withPermanent Atrial Fibrillation (for at least 6 months) with a resting ventricularrate <100/min, controlled with a rate control strategy (i.e., selective β-blocker,calcium channel blocker, pacemaker placement, digoxin, or ablation therapy) can beconsidered for the enrollment.

14. ECG criteria: An abnormal and clinically significant 12-lead electrocardiogram (ECG)which may impact the safety of the subject according to Investigator's judgement. Interms of the QTcF, subjects with QTcF >450ms for males or QTcF >470ms for females atscreening or at randomization visits (criterion not applicable for subject withpacemaker or permanent atrial fibrillation).

15. Other medical conditions: Other active severe acute or chronic medical orpsychiatric condition or laboratory abnormality that may increase the riskassociated with study participation or study drug administration or may interferewith the interpretation of study results and, in the judgment of the investigator,would make the subject inappropriate for entry into this study.

16. Vaccination: Subjects having received a vaccination within 2 weeks prior toscreening or during the run-in period.

17. Subjects' wellbeing: Subjects mentally or legally incapacitated, including but notlimited to subjects who are institutionalized or incarcerated.

18. Hypersensitivity: Subjects with known intolerance, hypersensitivity orcontraindication to treatment with ß2-agonists, ICS, or propellant gases/excipients.

19. Surgery: Subjects with major surgery in the 3 months prior to the screening visit orplanned surgery during the study.

20. Additional treatment: Subjects treated with non-potassium sparing diuretics (unlessadministered as a fixed-dose combination with a potassium conserving drug or changedto potassium sparing before the screening), non-selective beta-blocking drugs,quinidine, quinidine-like anti-arrhythmic, or any medication with a QTc prolongationpotential or a history of QTc prolongation.

21. Subjects treated with monoamine oxidase inhibitors (MAOIs) and tricyclicantidepressants.

22. Subjects with concomitant immunosuppressive therapy, use of oral or injectedcorticosteroids, anti-IgE, anti-IL5 or other monoclonal or polyclonal antibodieswithin 12 weeks prior to screening.

23. Subjects who are receiving any therapy that could interfere with the study drugsaccording to investigator's opinion.

24. Participating in other investigational trial: Subjects who have received aninvestigational drug within 1 month or 5 half-lives (whichever is greater) prior toscreening visit, or have been previously randomized in this trial, or are currentlyparticipating in another clinical trial.

25. Spacer: The need to use a spacer for correct self-administration of a pMDI.