D3.190 - Protocol for a real-world Study to Track Response to Oralair in Naïve patients with Grass pollen allergy (STRONG) in the Netherlands

The efficacy and safety of 5-Grass sublingual immunotherapy (SLIT) tablet for the treatment of grass pollen-induced allergic rhinoconjunctivitis (ARC) have been well established. Data on patient-reported outcomes and real-world evidence, focusing on patient benefits, quality of life, and treatment satisfaction across different ages in clinical practice, however, remain limited. Therefore, an observational study is carried out to evaluate patient-centered outcomes of 5- Grass SLIT-tablet in a real-world setting in the Netherlands.

This is a national, prospective, multicenter, non-interventional study in children, adolescents and adults with moderate to severe grass pollen induced ARC. Study patients’ participation will not influence therapeutic decisions and all treatments will be prescribed according to routine practice. The primary objective is to assess patient-reported outcomes, including symptom control, sleep quality, well-being, and overall treatment satisfaction, during the first year of treatment with 5-Grass SLIT-tablet. Further objectives are to assess changes in allergic symptom and medication use, evaluate the impact of treatment on sleep and work/school attendance and evaluating reasons for discontinuation of SLIT. Data are collected via electronic patient surveys and investigator-reported baseline characteristics at initiation, after the first pollen season (6-8 months), and at 12 months. Assessed outcomes include severity of allergic symptoms, ARIA classification, symptomatic medication use, sleep quality, overall well-being, work/school absenteeism, patient satisfaction, and treatment adherence over time.

The study started in October 2025 and is currently recruiting. A total of 100-150 grass pollen allergen sublingual immunotherapy naïve patients aged 5-65 years who are prescribed 5-Grass SLIT-tablet are anticipated to be included in different hospitals and out-patient clinics across the country.

This real-world, patient-centered study will provide comprehensive insights into the perceived benefits, tolerability, and adherence of 5-Grass SLIT-tablet across different age groups in routine clinical practice in the Netherlands.