Asthma Clinical Trial
Are you or your loved ones suffering from Asthma?
You may be eligible to participate in a clinical study to improve breathing problems caused by asthma.
Are you or your loved ones suffering from Asthma? You may be eligible to participate in a clinical study to improve breathing problems caused by asthma.
Details for the study
Treatments and/or Procedures
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 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 FEV1 ≥50% and <85% of their predicted normal value, after appropriate washout from bronchodilators, at the screening and randomization visits. - Subjects with a positive response to a reversibility test at screening (pre - post BD), within 1 year prior to or at screening defined as ΔFEV1≥12% and ≥200mL over baseline within 30 minutes after inhaling 4 puffs of albuterol HFA 90µg/actuation. - Use of inhaled corticosteroids (low/medium dose according to GINA Report 2016) with or without a LABD for 3 months (stable dose in the last 4 weeks) before screening visit - A cooperative attitude and ability to demonstrate correct use of the diary, peak flow meter, and pMDI inhalers. - A basal morning (7-10 am) serum cortisol level between 7-28 µg/dL at screening (V1). - A Body Mass Index: 18.5 ≤ BMI <35 kg/m2. Exclusion Criteria: - Pregnant (as evident by a positive urine hCG or serum β-hCG test) or lactating women and all women physiologically capable of becoming pregnant (i.e. women of childbearing potential) UNLESS they are willing to use a highly effective birth control method - Subjects who suffer from COPD as defined by the GOLD Report 2017, or are suspected of having Asthma COPD Overlap Syndrome (ACOS) as defined in GINA Report, 2016. - Inability to carry out pulmonary lung function testing, to comply with study procedures or with study drug intake. - Current smokers or ex-smokers (tobacco, vapor cigarettes, marijuana) with a smoking history of >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) >450ms for males or QTcF >470ms 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-IgE, anti-IL5 or other monoclonal or polycolonal 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.