Stable persistent asthma MedDRA version: 13.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: CHF 5188 pMDI
Pharmaceutical Form: Pressurised inhalation, solution
INN or Proposed INN: Budesonide
CAS Number: 51333223
Current Sponsor code: CHF 1536
Concentration unit: µg microgram(s
Sponsors
Chiesi Farmaceutici S.p.A
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · Written informed consent obtained; · Male or female patients aged = 18 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients will not be enrolled at Visit 1 into the run-in period if they meet any of the following criteria: · Inability to carry out pulmonary function testing; · Diagnosis of COPD as defined by the current GOLD guidelines; · Current smoker or ex-smoker with total cumulative exposure equal or more than 5 pack-years and/or having stopped smoking one year or less prior to study start; · History of near fatal asthma; · Evidence of severe asthma exacerbation or symptomatic infection of the airways in the previous 4 weeks (e.g. oral corticosteroids intake); · Patients presenting with 3 or more asthma exacerbations in the previous year; · Hospitalisation due to asthma during the previous 8 weeks; · Patients treated with oral or intravenous corticosteroids in the past 4 weeks or depot injectable corticosteroids in the past 8 weeks; · Patients treated with short-acting ß2-agonists in the past 8 hours, long-acting ß2-agonists in the past 48 hours, short-acting anticholinergics in the past 12 hours, long-acting anticholinergics (i.e. tiotropium bromide) in the past 48 hours, leukotriene antagonists in the past 2 weeks; · Patients treated with Duovent® and Berodual® in the past 12 hours; · Patients treated with an inhaled combination drug (eg Seretide®, Symbicort®) in the past 48 hours; · Patients who have changed their dose or formulation of inhaled corticosteroids during the previous 4 weeks; · History or current evidence of heart failure, coronary artery disease, myocardial infarction, severe uncontrolled hypertension, cardiac arrhythmias or any other significant cardiovascular disease; · Patients presenting with a clinically significant abnormality at a 12-lead ECG; · Patients presenting with serum potassium 6.0 mmol/L; · Patients presenting with fasting blood glucose > 8 mmol/L; · Clinically significant or unstable concomitant disease, · Cancer or any other chronic disease with poor prognosis and /or affecting patient status; · Pregnant or lactating females or females at risk of pregnancy, i.e. those not making use of an effective contraceptive method. A pregnancy test will be performed at screening in women of childbearing potential; · History of alcohol or drug abuse; · Allergy, sensitivity or intolerance to beta2-aderenergic agonists and/or study drug formulation ingredients; · Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study; · Patients who received any investigational new drug within the last 8 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish the cardiac safety (QTcB interval) and the efficacy (FEV1) of cumulative-doses of CHF 5188.;Secondary Objective: To evaluate the safety and tolerability of CHF 5188 given in cumulative doses.;Primary end point(s): · QTcB interval (change from pre-dose to 6 hours after the last cumulative dose) · FEV1 (% change from pre-dose to 120 min after the last cumulative dose). | — |
Countries
United Kingdom
Outcome results
None listed