Rhinoconjunctivitis induced by Parietaria J. MedDRA version: 20.0 Level: LLT Classification code 10001728 Term: Allergic rhinoconjunctivitis System Organ Class: 100000004853
Conditions
Interventions
Trade Name: ROBILAS - 20 MG COMPRESSE 20 COMPRESSE IN BLISTER AL/AL
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: BILASTINA
CAS Number: 0202189-78-4
Current Sponsor code: NA
Other descr
Sponsors
MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG SA
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: 1 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: - 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.;Main Objective: 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.;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.;Timepoint(s) of evaluation of this end point: From baseline to end of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Symptom improvement after nasal provocation test through TSS evaluation.;Timepoint(s) of evaluation of this end point: During visit 2 and visit 3 | — |
Countries
Italy
Contacts
Public ContactDipartimento Medico
OPIS s.r.l.
Outcome results
None listed