E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Rhinoconjunctivitis induced by Parietaria J. |
Rinocongiuntivite indotta da parietaria |
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E.1.1.1 | Medical condition in easily understood language |
Rhinoconjunctivitis induced by Parietaria J. |
Rinocongiuntivite indotta da parietaria |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001728 |
E.1.2 | Term | Allergic rhinoconjunctivitis |
E.1.2 | System Organ Class | 100000004853 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective is to evaluate the effect of Bilastine on nasal inflammatory parameters (eosinophil cells) assessed by means of a nasal scraping test following NPT after 7 ± 2 days of treatment vs baseline. |
L’obiettivo primario è di valutare l’effetto di Bilastina sui parametri infiammatori nasali (eosinofili) determinato tramite scraping nasale successivo al test di provocazione dopo 7 ± 2 giorni di trattamento rispetto al basale. |
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E.2.2 | Secondary objectives of the trial |
- To evaluate the effect of Bilastine on nasal inflammatory parameters (neutrophil cells) evaluated with a nasal scraping test following NPT after 7 ± 2 days of treatment vs baseline. - To assess the effect of Bilastine on reducing symptoms during NPT using the Total Symptom Score (TSS) in subjects sensitized to Parietaria Judaica. - To evaluate the effects of NPT with with the allergene parietaria judaica and parietaria officinalis (Allerkin® test) on nasal inflammatory parameters assessed by means of nasal Nitric Oxide (NO) measurement, Fractioned Exhaled Nitric Oxide (FeNO) and acoustic rhinomanometry before and after treatment with Bilastine. |
- Valutare l’effetto di Bilastina sui parametri infiammatori nasali (neutrofili) determinato tramite scraping nasale successivo al test di provocazione dopo 7 ± 2 giorni di trattamento rispetto al basale. - Valutare l’effetto di Bilastina nella riduzione dei sintomi durante il test di provocazione utilizzando il punteggio TSS (Total Symptom Score) in soggetti sensibilizzati a Parietaria Judaica. - Valutare gli effetti sul test di provocazione con l’allergene parietaria judaica e parietaria officinalis (test Allerkin®) sui parametri infiammatori determinati tramite misurazione nell’ossido nitrico (Nitric Oxide – NO) nasale, dell’ossido nitrico esalato frazionato (Fractioned Exhaled Nitric Oxide - FeNO) e tramite rinomanometria acustica prima e dopo il trattamento con Bilastina. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female, aged 18-65 years. 2. A reliable history consistent with moderate to severe persistent rhinoconjunctivitis (sneezing, rhinorrhea, itchy nose, nasal blockage and/or itchy eyes, red eyes, watering eyes and/or itchy ear/palate) on exposure to Parietaria J. for at least 2 years and that has required symptomatic treatment. 3. Mean Total Rhinoconjunctivitis Symptom Score (TSS) ≥10 from 4 nasal symptoms and non-nasal symptoms over last pollen season. |
1. Sesso maschile o femminile, età 18-65 anni. 2. Anamnesi affidabile coerente con rino-congiuntivite allergica persistente da moderata a severa (starnuti, rinorrea, prurito nasale, ostruzione nasale e/o prurito agli occhi, occhi arrossati, lacrimazione e/o prurito alle orecchie/palato) all’esposizione a Parietaria Judaica da almeno 2 anni e che ha richiesto un trattamento sintomatico. 3. Punteggio TSS medio per la rino-congiuntivite ≥10 da 4 sintomi nasali e 4 sintomi non-nasali nella precedente stagione pollinica. |
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E.4 | Principal exclusion criteria |
1. Diagnosis of asthma requiring Global Initiative for Asthma (GINA) Step 3 (www.ginasthma.org) or higher treatment. 2. If asthmatic, a deterioration of asthma that resulted in emergency treatment or hospitalization in the 12 months before randomization, or a life-threatening asthma attack (e.g. one requiring intubation and mechanical ventilation) at any time in the past. 3. Use of any oral or parenteral corticosteroid at any time within 1 month prior to Screening. 4. Asthma requiring high-dose inhaled corticosteroids (ICS) or anti-IgE therapy within 6 months prior to Screening. 5. Forced expiratory volume in 1 second (FEV1) <80% of predicted, or other evidence of partly controlled or uncontrolled asthma. 6. Clinically significant confounding symptoms of allergy to relevant local seasonal allergens (e.g. tree, grass, mugwort or mold). 7. Immunosuppressive treatment within 3 months prior to Visit 1(except steroids for allergic and asthma symptoms). 8. Previous immunotherapy treatment with any Parietaria allergen product for more than 1 month within 5 years prior to screening. 9. Malignancy, autoimmune diseases, acute systemic disease. 10. Concomitant nasal diseases (chronic rhinosinusitis, nasal polyps, nasal turbinate hypertrophy). 11. Hypersensitivity to the active ingredients (bilastine, parietaria judaica, parietaria officinalis, naphazoline hydrochloride and salbutamol) or to excipients of the study treatments. 12. Patients at high risk of systemic reactions. 13. Patients with contraindications for adrenaline or other emergency room drugs. 14. Pregnancy or breastfeeding. 15. Women of childbearing potential (WOCBP), including peri-menopausal woman who had a menstrual period within 1 year, will not be allowed to participate in the study unless they use effective methods of contraception during the study period and for 4 weeks after study completion. |
1. Diagnosi di asma che richiede un trattamento GINA (Global Initiative for Asthma) Step 3 (www.ginasthma.org) o superiore. 2. Se asmatico, peggioramento dell’asma che ha avuto come esito un trattamento di emergenza o un ricovero ospedaliero nei 12 mesi precedenti la randomizzazione, o un attacco d’asma che ha messo il paziente in pericolo di vita (ad es. un attacco d’asma che ha richiesto intubazione e ventilazione meccanica) in qualsiasi momento nel passato. 3. Utilizzo di qualsiasi corticosteroide orale o per via parenterale in qualsiasi momento nel mese precedente lo screening. 4. Asma che ha richiesto corticosteroidi per inalazione (Inhaled Corticosteroids – ICS) ad alte dosi o terapia anti-IgE nei 6 mesi precedenti lo screening. 5. Volume espiratorio forzato in 1 secondo (Forced expiratory volume in 1 second - FEV1) < 80% del valore predetto, o altra evidenza di asma non controllata o parzialmente controllata. 6. Sintomi confondenti clinicamente significativi di allergia ai relativi allergeni locali stagionali (ad es. alberi, erba, artemisia o muffa). 7. Trattamento immunosoppressore nei 3 mesi precedenti la Visita 1 (ad eccezione di steroidi per sintomi allergici e di asma). 8. Pregressa immunoterapia con qualsiasi prodotto allergene di Parietaria per più di 1 mese nei 5 anni precedenti lo screening. 9. Patologia maligna, malattia autoimmune, patologia sistemica acuta. 10. Patologie nasali concomitanti (rino-sinusite cronica, polipi nasali, ipertrofia dei turbinati nasali). 11. Ipersensibilità agli ingredienti attivi (bilastina, parietaria judaica, parietaria officinalis, nafazolina cloridrato e salbutamolo) o agli eccipienti dei trattamenti in studio. 12. Pazienti ad alto rischio di reazioni sistemiche. 13. Pazienti che presentano controindicazioni all’adrenalina o ad altri farmaci da pronto soccorso. 14. Gravidanza o allattamento. 15. Le donne potenzialmente fertili, incluse le donne in fase di peri-menopausa che hanno avuto un ciclo mestruale entro l’anno, non potranno partecipare allo studio a meno che non utilizzino metodi contraccettivi efficaci durante il periodo di studio e per 4 settimane dopo il completamento dello stesso. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Difference in the percentage of responders between the two treatment groups. Responders are defined as patients with a 1-point or more reduction in eosinophils cells’ grading, evaluated with nasal scraping, from baseline to end of treatment. |
Differenza nella percentuale di pazienti responder nei due gruppi di trattamento. I pazienti responder sono definiti come i pazienti con una riduzione di 1 punto o più nella valutazione degli eosinofili determinata con lo scraping nasale, dal basale alla fine del trattamento. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
From baseline to end of treatment. |
Dal basale alla fine del trattamento. |
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E.5.2 | Secondary end point(s) |
Symptom improvement after nasal provocation test through TSS evaluation. |
Miglioramento dei sintomi dopo il test di provocazione nasale tramite valutazione TSS. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
During visit 2 and visit 3 |
Durante la visita 2 e la visita 3 |
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
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 | Information not present in EudraCT |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 15 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 15 |