About this sponsor
We are an international company based in Parma, with more than 80 years of experience and a strong focus on research, development, production and the commercialization of innovative medicines in th...
You will receive
Study related treatment at no cost
Compensation of $50 per visit (6 visits)
Study related procedures
Travel expenses covered
Medical related treatment
No insurance needed
To qualify, you must be
Male or Female
18 - 75
This is where the study procedures will take place
Travel expenses may be reimbursed
Recruiting United States, Pearland Texas
Recruiting United States, Daytona Beach Florida
Recruiting United States, San Diego California
Recruiting United States, Colorado Springs Colorado
Recruiting United States, Medford Oregon
Withdrawn United States, Sylvania Ohio
Recruiting United States, Gastonia North Carolina
Recruiting United States, Cypress Texas
Recruiting United States, Kissimmee Florida
Recruiting United States, Los Angeles California
Recruiting United States, Clearwater Florida
Withdrawn United States, Madison Wisconsin
About This Condition
Click each topic to learn more
Who can participate?
Ideal candidates should meet the following criteria
- A Body Mass Index: 18.5 ≤ BMI <30 kg/m2.
- A cooperative attitude and ability to demonstrate correct use of the diary, peak flow meter, and pMDI inhalers.
- Subjects under stable dose of ICS (low/medium dose according to GINA guidelines 2016) for 3 months before screening visit.
- 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 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 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).
- A diagnosis of asthma as defined in the GINA Report, 2016, documented for at least 1 year prior to screening.
- 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 basal morning (8-10 am) serum cortisol level between 7-28 µg/dL at screening (V1).
Reasons you may not be a good fit
- 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 with known intolerance/hypersensitivity or contra-indication to treatment with ß2-adrenergic receptor agonists, inhaled corticosteroids or propellant gases/excipients.
- 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.
- 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.
- 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.
- History of life-threatening asthma, clinically significant uncontrolled disease or respiratory infection.
- 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.
- Inability to carry out pulmonary lung function testing, to comply with study procedures or with study drug intake.
- 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.
- 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 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.
About This Study
An 8 week Dose Ranging Study of CHF 718 pMDI in Asthmatic Subjects
An 8-week, Multicenter, Randomized, Double-blind, Placebo and Active-controlled, Parallel Group, Dose-ranging Study to Evaluate the Efficacy and Safety of 3 Doses of CHF 718 pMDI (HFA Beclomethasone Dipropionate Via Pressured Metered Dose Inhaler) in Asthmatic Subjects.
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.
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. After a 2 week run-in period under rescue albuterol as needed and background inhaled corticosteroid (ICS), patients will be randomized to one of the 5 study treatment groups. After randomization, patients will be assessed after 4 and 8 weeks of study treatment at the center. A follow-up phone call will be performed a week after the last visit. During the study, daily asthma symptoms, peak expiratory flow, rescue and background medication use, and compliance with the study medication will be recorded via subject diary. Treatment-Emergent Adverse Events (TEAEs) will be assessed and recorded throughout the study. At screening and subsequent visits, patients will undergo physical and vital signs examinations, spirometry measurements, and 12-lead ECG. Routine hematology, blood chemistry, and pregnancy testing will be performed before enrollment and at end of study. 24-hr urine cortisol and creatinine will be assessed before and after the first dose and just before the last dose of study treatment.
What will be monitored/measured (Outcomes)
Change from baseline in pre-dose morning FEV1 at Week 8
24-hr Urinary Free Cortisol and Creatinine
Change from baseline in pre-dose morning FEV1 at Week 4
12-lead ECG parameters (HR, QTcF, QRS, PR)
Standard blood chemistry and hematology
Adverse Events (AEs) and Adverse Drug Reactions (ADRs)
Change from baseline in % asthma control days
Change from baseline in % asthma symptoms-free days
Change from baseline in % rescue medication-free days
Change from baseline in ACQ-7 score at Week 4 and 8
4Weeks & 8 Weeks
Vital signs (systolic and diastolic blood pressure)
Change from baseline in pre-dose morning FVC at Week 4 and 8
4 Weeks & 8 Weeks
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