An 8-week Dose Ranging Study of CHF 718 pMDI in Asthmatic Subjects

Inclusion Criteria

• Male or female subjects aged ≥18 and ≤75 years who have signed an Informed Consent form prior to initiation of any study-related procedure.
• A diagnosis of asthma as defined in the Global Initiative for Asthma (GINA) Report, 2016, documented for at least 1 year prior to screening.
• Subjects with poorly controlled or uncontrolled asthma evidenced by a score at the Asthma Control Questionnaire 7 © (ACQ-7) ≥1.5 (this criterion must be met at screening and at randomization visits).
• Subjects with a pre-bronchodilator Forced Expiratory Volume in the 1st Second (FEV1) ≥50% and 10 pack-years or having stopped smoking one year or less prior to screening visit.
• History of life-threatening asthma, clinically significant uncontrolled disease or respiratory infection.
• An asthma exacerbation requiring oral corticosteroids within 3 months or hospitalization within 6 months prior to screening.
• Subjects with unresolved bacterial or viral respiratory tract, sinus or middle ear infection affecting asthma status within 2 weeks prior to screening.
• Subjects who received a vaccination within 2 weeks prior to screening or during the run-in.
• Subjects with oral candidiasis at screening or at randomization.
• Subjects with any clinically significant, uncontrolled condition
• Subjects who have clinically significant cardiovascular condition
• Subjects who have a clinically significant abnormal 12-lead ECG that results in active medical problem which may impact the safety of the subject according to Investigator's judgement.
• Subjects whose 12-lead ECG shows Fridericia corrected QT interval (QTcF) >450 ms for males or QTcF >470 ms for females at screening and randomization visits.
• Subjects with known intolerance/hypersensitivity or contra-indication to treatment with ß2-adrenergic receptor agonists, inhaled corticosteroids or propellant gases/excipients.
• Subjects with concomitant immunosuppressive therapy, use of oral or injected corticosteroids, anti-Immunoglobulin E (IgE), anti-Interleukin 5 (IL5), or other monoclonal or polyclonal antibodies within 12 weeks prior to screening.
• Use of potent cytochrome P450 3A4 inhibitors and inducers within 4 weeks prior to screening.
• History of alcohol abuse and/or substance/drug abuse within 12 months prior to screening.
• Subjects who have received an investigational drug within 1 month or 5 half-lives (whichever is greater) prior to screening visit, or have been previously randomized in this trial, or are currently participating in another clinical trial.
• Subjects who are mentally or legally incapacitated, or subjects accommodated in an establishment as a result of an official or judicial order.
• Subjects who have undergone major surgery in the 3 months prior to screening visit or have a planned surgery during the trial.