Bilastine for Allergic rhinoconjunctivitis

Inclusion criteria

• {"criterion_text":"- Participants of either sex (male or female) aged ≥ 6 and < 12 years with a body weight of at least 15 kg at the time of enrolment\n- Participants must have a documented clinical history (at least 1 year) of AR and must present mild-moderate clinical symptoms at the time of inclusion in the study\n- Participants with AR must have a positive skin reaction/RAST test documented in their clinical history within a year prior to the date of their inclusion in the study: a positive prick test (papule diameter of at least 3 mm) or specific IgE > 0.70 KUA/L, at least against one allergen.\n- Participants must have a clinical history of positive response to oral antihistamine treatment\n- Participants must have a T5CSS score ≥ 8 points (out of 15) instantaneous symptoms at the screening visit\n- Participants must have at least one analytical determination (haemogram, biochemistry) prior to entering in the study without clinically relevant abnormalities. Should there have been any past anomalies, it should be verified and documented with the corresponding analytical determination that they have been normalized and presents values within the normal range before inclusion in the study.\n- Participants should have a 12-lead ECG without clinically relevant abnormalities.\n- Written consent must be obtained from parents/LAR of the children for them to be included in the study. A signed assent form might be obtained from the participants, if required"}

Exclusion criteria

• {"criterion_text":"- Rhinitis of non-allergic origin.\n- Current or planned consumption of grapefruit, apple, orange, or other fruit juices known to affect drug absorption during the treatment period.\n- Any relevant clinical condition (or history) of renal, hepatic, gastrointestinal, cardiovascular, respiratory, hematologic, endocrine, or neurologic disease that would preclude the child from being suitable for participate in the study or that may interfere with the objectives of the study, in the opinion of the investigator.\n- Clinically relevant abnormalities in laboratory parameters (including ECG abnormalities) indicative of disease, in the opinion of the investigator.\n- Children or parents/LAR of the children unable to comply with the requirements of the study (attendance at visits), or children unable to adequately take the study treatment\n- Participation in another clinical trial within 30 days prior to ingestion of the first dose of study medication.\n- Any other characteristic of the participant or his/her environment, which in the investigator's judgment makes him/her unsuitable to participate in the study (e.g., detection or suspicion of drug or other substance abuse; if participation in the study may harm the child's health, etc.).\n- Administration of drugs with sedative properties\n- Known allergy and/or hypersensitivity to H1 antihistamines (specifically to the study medications -bilastine - or to their inactive ingredients) or to benzimidazoles\n- Participants who are taking or have taken any of the following medications prior to inclusion in the study and who have not complied with the specific washout period indicated below: a. Oral and nasal corticosteroids (within the 30 days before inclusion) b. Topical ocular or nasal antihistamines (within the 7 days before inclusion) c. Systemic antihistamines: i. loratadine and desloratadine: 10 days before inclusion ii. dexchlorpheniramine: 8 days before inclusion iii. ebastine and hydroxyzine: 6 days before inclusion iv. bilastine, fexofenadine, promethazine, cyproheptadine, oxatomide and clemastine: 5 days before inclusion v. cetirizine and levocetirizine: 3 days before inclusion vi. rupatadine: 2 days before inclusion d. Decongestants, anticholinergics (nasal spray or drops) (within the 3 days before inclusion) e. Anti-leukotrienes (within the 7 days before inclusion) f. Ketotifen (within the 2 weeks before inclusion) g. Delayed-acting corticosteroids (within the 3 months before inclusion) h. Macrolide antibiotics and imidazole fungicides (systemic) (within the 7 days before inclusion) i. Investigational medication or antibodies (within the 30 days before inclusion)\n- Participants with asthma treated with treatments other than β2 inhaled agonists\n- Participants under treatment with drugs that are contraindicated or interact with the study drugs according to its SmPC, such as P-glycoprotein inhibitors (ketoconazole, erythromycin, cyclosporine, diltiazem), anticholinergics, drugs that prolong the QT interval and/or induce Torsade de Pointes, such as class IA antiarrhythmics (quinidine, etc. ) and class III (amiodarone, etc.), antipsychotics (haloperidol), antidepressants (citalopram, etc.), antimalarials (mefloquine, etc.), antibiotics (such as moxifloxacin) and antifungals (such as pentamidine). The association with some gastrointestinal drugs (such as prucalopride), cancer drugs (e.g. toremifene) or methadone should also be avoided.\n- Participants under treatment with Allergen-Specific Immunotherapy in the two years prior to inclusion in the study.\n- Participants under treatment with stimulant drugs and/or Central Nervous System depressants.\n- Girls with menarche."}

Primary endpoints

• {"endpoint_text":"- Overall AR symptoms will be evaluated through the mean change of the T5CSS score measured at baseline (V1) and after 14 days (V3) of treatment by a participant’s e-diary","definition_or_measurement_approach":"Mean change vs baseline in the T5CSS (combined five symptoms score: sneezing, rhinorrhoea, nasal pruritus, tearing and ocular pruritus) measured at baseline (V1) and after 14 days (V3); reflective AR symptoms collected daily referring to the preceding 12-24 hours via participant e-diary."}

Italy

Earliest CTIS Part Ii Submission Date

17-12-2025

Latest Decision Or Authorization Date

19-01-2026

Processing Time Days

33

Number Of Sites

2

Number Of Participants

14

Spain

Earliest CTIS Part Ii Submission Date

06-10-2025

Latest Decision Or Authorization Date

19-01-2026

Processing Time Days

105

Number Of Sites

4

Number Of Participants

28

Poland

Earliest CTIS Part Ii Submission Date

09-01-2026

Latest Decision Or Authorization Date

26-01-2026

Processing Time Days

17

Number Of Sites

4

Number Of Participants

28

Primary sponsor

Full Name

Faes Farma S.A.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Spain

Third parties

• {"country":"Spain","full_name":"Evidenze Health Espana S.L.","duties_or_roles":"1,10,11,12,5,6,7","organisation_type":"Pharmaceutical company"}

Co-sponsors

• A. Menarini Industrie Farmaceutiche Riunite S.r.l.