Moderate or Severe Persistent Asthma MedDRA version: 12.0 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Interventions
Product Name: CHF5188 pMDI
Product Code: CHF5188
Pharmaceutical Form: Pressurised inhalation, solution
INN or Proposed INN: Budesonide
CAS Number: 51333-22-3
Other descriptive name: Budesonide
Concent
Sponsors
Chiesi Farmaceutici S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent obtained; 2. Male or female patients aged = 18 years; 3. Patients with moderate or severe asthma partly controlled with ICS or ICS/LABA at a stable dose for at least 8 weeks prior to inclusion, according to the GINA 2008 “Management Approach Based On Control"; 4. Patients with Forced Expiratory Volume in the first second (FEV1) = 60% and = 90% of predicted for the patient normal value; 5. Patients with a documented positive response to the reversibility test, defined as an increase of at least 12% and at least 250mL from pre-dosing values in the measurement of FEV1 within 30 minutes after the inhalation of 400 µg salbutamol pMDI; If the reversibility criteria are not met, the testing can be repeated once. This requirement must be met after re-testing during run-in period at least 24h prior to randomisation. 6. Patients with a co-operative attitude and ability to be trained to correctly use the pMDI. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Inability to carry out pulmonary function testing; 2. Diagnosis of COPD as defined by the current GOLD guidelines; 3. Current smokers or ex-smokers with total cumulative exposure equal or more than 5 pack-years and/or having stopped smoking one year or less prior to study start; 4. History of near fatal asthma or of a past hospitalisation for asthma in ICU; 5. Evidence of severe asthma exacerbation or symptomatic infection of the airways in the previous 4 weeks (e.g. oral corticosteroids intake); 6. Patients presenting with 3 or more asthma exacerbations in the previous year; 7. Hospitalisation due to asthma during the previous 8 weeks; 8. History of significant seasonal variation of asthma; 9. Patients treated with oral or intravenous corticosteroids in the past 4 weeks or depot injectable corticosteroids in the past 8 weeks; 10. Patients had used any of the following medications prior to screening and has not met the specified minimum wash-out period: short-acting ß2-agonists : 6 hours, long-acting ß2-agonists : 24 hours, short-acting anticholinergics : 12 hours, leukotriene modifiers : 4 weeks, Fixed combinations of an anti-cholinergic and short-acting ß2-agonist (e.g. Duovent® and Berodual®) :12 hours, oral or nebulised bronchodilators : 4 weeks, nebulised corticosteroids : 4 weeks, sodium cromoglycate or nedocromil sodium : 4 weeks; Patients have received live-attenuated virus vaccination within 2 weeks prior to screening (inactivated influenza vaccination is acceptable provided it is not administered 48h prior to screening) 12. Patients with a history or current evidence of heart failure, coronary artery disease, myocardial infarction, severe uncontrolled hypertension, cardiac arrhythmias or any other significant cardiovascular disease; 13. Patients presenting with a clinically significant abnormality at a 12-lead ECG or presenting a QTcF interval in ECG > 450msec (males) or > 470msec (females); 14. Patients presenting with serum potassium 6.0mmol/L; 15. Patients presenting with fasting blood glucose > 8 mmol/L; 16. Patients with a clinically significant or uncontrolled concomitant disease: e.g. uncontrolled hyperthyroidism, uncontrolled diabetes mellitus or other endocrine disease; significant hepatic impairment; significant pulmonary disease (e.g. tuberculosis, lung cancer or other), gastrointestinal disease (e.g. active peptic ulcer or other), neurological disease, haematological disease, autoimmune disorders or other; 17. Patients with active cancer or a history of cancer with less than 5 years disease free survival time or any other chronic disease with poor prognosis and /or affecting patient status; 18. Pregnant or lactating females or females at risk of pregnancy, i.e. those not making use of an effective contraceptive method (oral contraception, UID, double barrier method (spermicide + condoms or spermicide + diaphragm), tubal ligature). A pregnancy test will be performed at screening in women of childbearing potential; 19. Patients with a history of alcohol or drug abuse; 20. Patients with a known intolerance/hypersensitivity to beta2-aderenergic agonists, propellant gases/excipients; 21. Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study; 22. Patients who received any investigational new drug within the last 4 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate superiority of CHF5188 pMDI 400/4µg administered once-a-day in the morning over budesonide extrafine pMDI on trough FEV1 after 4 weeks of treatment in persistent moderate or severe asthmatic patients partly controlled with ICS or ICS/LABA.;Secondary Objective: - To compare the efficacy of CHF5188 given once-a-day with that of Seretide® Evohaler pMDI 50/25µg administered twice-a-day after 4 weeks of treatment - To assess the occurrence of tolerance by comparing the effect on trough and peak FEV1 after the first and the last dose of study drug - To monitor safety and tolerability ;Primary end point(s): Trough FEV1 (mean 23h-24h FEV1) after day 28 dose | — |
Countries
Germany, United Kingdom
Outcome results
None listed