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

• Status: Completed
• Trial end date: 2018-12-05
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the dose-response of different doses of CHF 781 pMDI on lung function and other clinical outcomes, to identify the optimal dose(s) in terms of benefit/ risk ratio for further development in the target patient population.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chiesi Farmaceutici S.p.A.
• Treatments: Beclomethasone

Criteria

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.