idiopathic angioedema
Conditions
Sponsors
Menarini International Operation Luxembourg SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Subjects must have given a written informed consent 2.Male or female; 3.Age = 18 years; 4.Diagnosis of chronic IAE (according to Kaplan-Greaves 2005 criteria) 5.Presence of = 4 days of moderate to severe cutaneous or mucosal symptoms of angioedema per 4 weeks, in the last 12 weeks or more 6.No angioedema symptoms when starting the treatment 7.C1-inhibitor functional levels = 60% of normal values 8.Able to complete screening and assessments 9.Women of childbearing potential must have a negative urine pregnancy test; 10.Willingness and ability to participate in the study. 11.No other experimental treatments. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1.Diagnosis of angioedema of any defined cause: allergic, hereditary/acquired C1-Inhibitor deficiency, ACE (Angiotensin Converting Enzyme) inhibitor or NSAID induced angioedema, drug and/or food/disease induced angioedema (according to Kaplan-Greaves 2005 criteria); 2.Participation in a clinical trial of another Investigational Product (IP) within the past month; 3.On treatment with ACE inhibitors or ARB (Angiotensin Receptor Blockers); 4.Evidence of clinically relevant cardiovascular disease or thrombophylic condition 5.History of autoimmune disorders, Hodgkin’s disease and any clinically significant condition (neurological, hepatic, renal or malignant diseases) that upon the judgment of the investigator contraindicates participation to the study; 6.Pregnancy and/or breast-feeding; 7.Mental condition rendering the subject, in the opinion of the investigator, unable to understand the nature, scope and possible consequences of the study; 8.Unlikely to comply with the protocol, for example, uncooperative attitude, inability to return for follow-up visits, or unlikely to complete the study for any reason; 9.Known hypersensitivity to bilastine, its excipients, H1-antihistamines, benzimidazoles 10.Patient with concomitant drugs as systemic or topical corticosteroids within 4 weeks, astemizole within 6 weeks, ketotifen within 2 weeks, any other systemic antihistamine (including loratadine, desloratadine, ebastine, rupatadine, mizolastine, cetirizine or levocetirizine) within 3 days, anti-leukotrienes within 3 days, sodium cromoglycate or nedocromil within 2 weeks, and tricyclic antidepressants within 1 week of randomization and ace-inibhitors, sartan drugs, cinnarizine, with the exception of the case in which some of them have been used for the symptoms.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of the antihistamine bilastine compared with placebo in preventing angioedema symptoms evaluated as reduction of the number of days with moderate to severe angioedema in patients with IAE, in comparison to baseline situation. ; Secondary Objective: 1.To assess the proportion of subjects that during the treatment period has a number of days with moderate to severe angioedema = 2 every 8 weeks 2.To assess the need for therapy of angioedema attacks and the duration of treatment 3.To assess the safety and tolerability of bilastine compared to placebo. ;Primary end point(s): To assess the efficacy of the antihistamine bilastine compared with placebo in preventing angioedema symptoms evaluated as reduction of the number of days with moderate to severe angioedema in patients with IAE, in comparison to baseline situation. ;Timepoint(s) of evaluation of this end point: Baseline assessment prior to randomization; final assessment at the end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.To assess the proportion of subjects that during the treatment period has a number of days with moderate to severe angioedema = 2 every 8 weeks 2.To assess the need for therapy of angioedema attacks and the duration of treatment 3.To assess the safety and tolerability of bilastine compared to placebo. ;Timepoint(s) of evaluation of this end point: Randomization visit until 30 days after the end of treatment | — |
Countries
Italy
Contacts
Public ContactAlessandra Spinali
A. Menarini Industrie Farmaceutiche Riunite S.r.l.
Outcome results
None listed