Number Type Age Range Length of study Compensation
CCD-05993AA3-01 Adult Asthma 18 - 75 yrs. approx. 8 weeks for time/travel
This is a phase II, multicenter, randomized, double-blind, placebo and active controlled dose ranging 5-arm parallel group study to identify the optimal dose of CHF 781 pMDI with respect to lung function and other clinical efficacy and safety outcomes.
- 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 ≥ 60% and <80% 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), defined as ΔFEV1≥12% and ≥200mL over baseline 10-15 minutes after inhaling 4 puffs of albuterol HFA 90µg/actuation.
- Subjects under stable dose of ICS (low/medium dose according to GINA guidelines 2016) for 3 months before screening visit.
- A cooperative attitude and ability to demonstrate correct use of the diary, peak flow meter, and pMDI inhalers.
- A basal morning (8-10 am) serum cortisol level between 7-28 µg/dL at screening (V1).
- A Body Mass Index: 18.5 ≤ BMI <30 kg/m2.
- 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 current GOLD 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 and vapor cigarettes) 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) >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-IgE, anti-IL5 or other monoclonal or polycolonal antibodies within 12 weeks prior to screening.
- Use of potent cytochrome P450 3A4 inhibitors 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.