Allergic rhinoconjunctivitis due to birch pollen is a seasonal problem which manifests as a combination of nasal symptoms (such as congestion, runny nose, sneezing, itching of the nose) and ocular symptoms (such as red, itchy and watery eyes). For several birch-allergic patients, allergic rhinoconjunctivitis occurs with an oral allergy syndrome.
The purpose of this study is to demonstrate the safety and efficacy of the study drug (STALORAL Birch 300 IR) in children and adolescents with birch pollen-induced allergic rhinoconjunctivitis, with or without asthma, when treated before and during the pollen season.
Approximately 699 children will participate in this study. The study will be conducted worldwide in approximately 80 medical sites in about 12 countries. The total duration of the study will be approximately 20 months.
Who can participate
Age range5 Years – 17 Years
SexALL
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Inclusion criteria
✓. Able to sign and date the informed consent/assent form prior to any trial-specific procedure. Patients may check a box on the assent form if they are unable to provide a signature.
✓. Covered by a health insurance system as per local regulation.
✓. Aged ≥5 to ≤17 years old at the randomisation visit.
✓. Documented, physician diagnosed, clinically relevant history of moderate to severe ARC induced by birch pollen (with or without asthma) despite having received treatment with symptom-relieving medication during at least 1 previous birch pollen season for ages 4 through 6 or at least 2 previous birch pollen seasons for ages 7 through 17 years at screening.
✓. A Retrospective ARC Total Symptom Score (TSS) based on the previous birch pollen season at least 12 out of a maximum possible score of 18 AND a retrospective score of at least 30 on a general Visual Analog Scale (VAS) (0-100) on the severity of symptoms as evaluated by the patient or by the parent/authorised legal representative if the patient is not able to perform the assessment, at screening.
✓. Positive Skin Prick Test (SPT) to Betula pendula at screening visit (the SPT is considered positive if it results in a wheal diameter ≥ 3.0 mm \[with positive control (histamine) ≥ 3.0 mm and negative control = 0 mm\]). The Sponsor will accept to include patients who have a documented positive SPT in their medical records if this SPT was performed during the previous 6 months preceding the screening visit at the same investigational site in which they are enrolled.
What they're measuring
1
The primary efficacy endpoint will be the average ARC Total Combined Score (TCS) (TCS0-38) over the entire Birch Pollen Season (BPS) 2.
Timeframe: Following visits after starting the study: at 16 months, 18 months
✓. Positive specific Immunoglobulin E (IgE) to pollen allergens of Betula pendula at screening (CAP-RAST birch pollen allergens specific IgE ≥ 0.7 kU/L).
✓. Negative urine pregnancy test on all female patients of childbearing potential or who have had their first menarche prior to randomisation.
Exclusion criteria
✕. Any clinical deterioration of asthma (i.e., asthma exacerbation) that resulted in emergency procedure/treatment or treatment with systemic corticosteroids within 3 months prior to randomisation.
✕. For patients ≥7 years old:
✕. Server or uncontrolled asthma with asthmatic therapies consistent with steps 4 or 5 as defined by Global Initiative for Asthma (GINA) 2022 received within 12 months prior to entry in the trial. Asthmatic patients with asthmatic therapies consistent with steps 1, 2 or 3 must be controlled (i.e. patients with controlled, mild and moderate asthma are eligible).
✕. Severe oral inflammations such as oral lichen planus, oral ulcerations or oral mycosis.
✕. Acute or chronic inflammatory or infectious upper airway diseases (excepted mild to moderate asthma) including recurrent acute or chronic sinusitis.
✕. History of eosinophilic oesophagitis or with current severe or persistent gastroesophageal symptoms including dysphagia or chest pain that, in the opinion of the investigator, may constitute an increased safety concern.
✕. A relevant history of systemic allergic reaction (e.g., anaphylaxis with cardiorespiratory symptoms, generalised urticaria or severe facial angioedema) that, in the opinion of the Investigator, may constitute an increased safety concern.
✕. Any disease that prohibits the use of adrenaline (e.g., hyperthyroidism).