E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Eosinophilic Esophagitis |
Esofagite Eosinofila |
|
E.1.1.1 | Medical condition in easily understood language |
Eosinophilic Esophagitis |
Esofagite Eosinofila |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
evaluate the efficacy of budesoniode treatment, a viscous oral suspension, in patiens affected with Eosinophilic Esophagitis, in whom other type of therapies have failed or patients with relapse, or newly diagnosed patients. Evaluate treatment safety in terms of adverse reactions or impact on the cortical-adrenal activity. |
Valutare l'efficacia del trattamento con Budesonide,una sospensione orale viscosa, in pazienti affetti da Esofagite Eosinofila, nei quali altri tipi di terapie hanno fallito o pazienti con recidiva, o pazienti di primo accertamento. Valutare lasicurezza del trattamento in termini di reazioni avverse o di impatto sull'attività cortico-surrenalica |
|
E.2.2 | Secondary objectives of the trial |
Not Applicable |
Non Applicabile |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
patients of both gender aged below 18 yrs with diagnosis of eosinophilic esophagitis verified by histological examination of esophageal biopsies (eosinophil count >/= 15/HPF)
Newly diagnosed patients or previously put under restricted diet or treated with fluticasone/budesonide nebulizer suspension with negative results or relapse.
|
pazienti di ambo i sessi con età ≤ 18 anni con diagnosi di esofagite eosinofila accertata con EGDS ed esame istologico delle biopsie esofagee (eosinofili ≥15/HPF)
pazienti di nuova osservazione o precedentemente trattati con regime dietetico o con fluticasone/budesonide spray/sospensione per nebulizzazione con esiti negativi o in recidiva
|
|
E.4 | Principal exclusion criteria |
Age > 18 yrs
Patients with concomitant crhonic intestinal pathologies, heart or gut, respiratory or kidney malformations , neurological deficit, uncertain diagnosis of Eosinophilic Esophagitis |
età ≥ 18 anni
pazienti con concomitanti patologie croniche intestinali ed extraintestinali, malformazioni cardiache o dell’apparato gastrointestinale, respiratorio o renale, deficit neurologici, diagnosi incerta di Esofagite Eosinofila |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Decrease of eosinophilic infiltration, evaluated by biopsy at 0, 12 and 36 (follow-up) weeks. |
Riduzione infiltrazione Eosinofila, valutata al basale e alle settimane 12 e 36(follow-up) mediante biopsia |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
0, 12 and 36 (follow-up) week |
0, 12 e 36 (follow-up) settimane |
|
E.5.2 | Secondary end point(s) |
Not Applicable |
Non Applicabile |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Not Applicable |
Non Applicabile |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
LVLS |
Ultima visita dell'ultimo paziente |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |