Background/Objectives: For decades, only native allergen extracts with a high incidence of adverse drug reactions (ADRs) were available for allergen-specific immunotherapy (AIT)—generally administered subcutaneously—to treat allergy to feline epithelia. Modified allergen extracts are a promising alternative to reduce the number of ADRs. The purpose of this study was to collect data on the safety of a depigmented–polymerised cat allergoid under real-world conditions in clinical routine. Methods: This study was designed as a voluntary non-interventional post-authorisation safety study (NIS-PASS), specifically focusing on adverse events (AEs)—including ADRs—that occur upon injection and assessing the influence on quality of life (QoL). The observation period was the initial phase (up-dosing) of the AIT. Results: Of 101 included patients, 91 patients were treated with the depigmented–polymerised cat allergoid. Regardless of the age group, around 50% of patients reported ADRs, which were mainly delayed local reactions (LRs). Other ADRs occurred only sporadically without persistent patient impairment. The ADR incidence did not differ significantly between quick and conventional up-dosing regimens or between adult and adolescent patient groups. The QoL data revealed no significant changes in any domains of the SF-12 questionnaire during the 12-week observation period. Conclusions: Overall, subcutaneous allergen immunotherapy (SCIT) with the depigmented–polymerised cat allergoid is a well-tolerated and safe treatment option for patients with cat allergy.

Background/Objectives: Allergen immunotherapy (AIT) is the only disease-modifying treatment for grass pollen allergy. However, the proportion of patients interested in AIT who meet guideline-defined eligibility criteria remains unclear. This study aimed to characterise symptom burden, medication use, and AIT eligibility in adult patients with grass pollen allergy during the peak pollen season. Methods: In this multicentre, prospective, non-interventional epidemiological study, 479 adults with confirmed grass pollen allergy recorded daily nasal, ocular, and systemic symptoms, as well as anti-allergic medication use, via a validated electronic diary (CCC STUDY Diary) over a 30-day period in June/July 2025. A combined symptom–medication score (CSMS) was calculated daily, with a predefined threshold of ≥1.5 indicating clinically relevant symptom severity and potential eligibility for AIT. Both additive and weighted calculation approaches for the CSMS and the daily medication score (dMS) were evaluated to assess methodological robustness and reproducibility. Results: The mean additive CSMS was 2.14, indicating moderate symptom burden. Overall, 63.3% of participants exceeded the CSMS threshold of 1.5 and were considered eligible for AIT. Sensitivity analyses demonstrated excellent concordance between additive and weighted CSMS/dMS calculations (Spearman’s ρ >0.98; p < 0.001), and Bland–Altman analysis confirmed minimal bias (0.157) and narrow limits of agreement. Asthma was reported as a comorbidity in 36% of patients, generally associated with mild to moderate daily respiratory symptoms. Limitations included the self-reported nature of the data and a slightly reduced sample size; however, the results are representative of adult patients seeking care in specialised allergy centres in Germany. Conclusions: The CSMS also in its additive and therefore modernised form is a reliable, reproducible, and clinically meaningful tool for quantifying symptom severity and identifying patients suitable for AIT. Approximately two-thirds of adults interested in grass pollen AIT exhibited moderate to severe symptoms and were eligible for treatment according to current guideline recommendations.

Background/Objectives: Allergen immunotherapy (AIT) is the only disease-modifying treatment for grass pollen allergy. However, the proportion of patients interested in AIT who meet guideline-defined eligibility criteria remains unclear. This study aimed to characterise symptom burden, medication use, and AIT eligibility in adult patients with grass pollen allergy during the peak pollen season. Methods: In this multicentre, prospective, non-interventional epidemiological study, 479 adults with confirmed grass pollen allergy recorded daily nasal, ocular, and systemic symptoms, as well as anti-allergic medication use, via a validated electronic diary (CCC STUDY Diary) over a 30-day period in June/July 2025. A combined symptom-medication score (CSMS) was calculated daily, with a predefined threshold of ≥1.5 indicating clinically relevant symptom severity and potential eligibility for AIT. Both additive and weighted calculation approaches for CSMS and the daily medication score (dMS) were evaluated to assess methodological robustness and reproducibility. Results: The mean additive CSMS was 2.14, indicating moderate symptom burden. Overall, 63.3% of participants exceeded the CSMS threshold of 1.5 and were considered eligible for AIT. Sensitivity analyses demonstrated excellent concordance between additive and weighted CSMS/dMS calculations (Spearman’s ρ >0.98; p<0.001), and Bland–Altman analysis confirmed minimal bias (0.157) and narrow limits of agreement. Asthma was reported as a comorbidity in 36% of patients, generally associated with mild to moderate daily respiratory symptoms. Limitations included the self-reported nature of the data and a slightly reduced sample size; however, the results are representative of adult patients seeking care in specialised allergy centres in Germany. Conclusions: The CSMS also in its additive and therefore modernized form is a reliable, reproducible, and clinically meaningful tool for quantifying symptom severity and identifying patients suitable for AIT. Approximately two-thirds of adults interested in grass pollen AIT exhibited moderate to severe symptoms and were eligible for treatment according to current guideline recommendations.

Background/Objectives: For decades, only native allergen extracts with a high incidence of adverse drug reactions (ADRs) were available for allergen-specific immunotherapy (AIT) - in general administered subcutaneously - to treat allergy to feline epithelia. Modified allergen extracts are a promising alternative to reduce the number of ADRs. The purpose of this study was to collect data on the safety of the depigmented allergoid from cat under real-world conditions in clinical routine. Methods: The study was designed as voluntary non-interventional post-authorization safety study (NIS-PASS) with specific focus on the occurrence of adverse events (AEs) – respectively ADRs – upon injections and on the assessment of the influence on quality of life (QoL). Period of observation was the initial phase (up-dosing) of the AIT. Results: 101 patients were included, of whom 91 patients were treated with the depigmented allergoid from cat. Regardless of the age group, around 50% of patients reported AD R s, which were mainly delayed local reactions (LR). Other ADRs occurred only sporadically without persistent impairment for the patients. The incidence of ADRs neither differed significantly between quick and conventional up-dosing regimens nor between adult and adolescent patient groups. The QoL data revealed no significant changes in any domains of the SF-12 questionnaire for the observation period of 12 weeks. Conclusions: Overall, subcutaneous allergen immunotherapy (SCIT) with depigmented allergoid from cat is a well-tolerated and safe treatment option for patients with cat allergy.

Background/Objectives: Drug-free nasal formulations may provide an alternative or adjunct to pharmacological treatment in patients with allergic rhinitis. This study in-vestigated the clinical performance, tolerability, and safety of a hypertonic nasal spray containing hydroxypropyl-β-cyclodextrin (BDNS) compared with 0.9% isotonic saline in adults with pollen-induced allergic rhinitis. Methods: This prospective, randomised, double-blind, controlled, two-period crossover study included 32 adults with pollen-induced allergic rhinitis. Participants were randomised 1:1 to receive BDNS followed by isotonic saline or the reverse sequence, with each treatment administered for 7 days. The primary endpoint was the mean Lebel Symptom Score following standard-ised nasal allergen provocation testing after each treatment period. Secondary out-comes included individual symptom scores, peak nasal inspiratory flow, nasal sensory tolerability, treatment satisfaction and preference, and safety. The primary analysis was conducted in the per-protocol set using a linear mixed-effects model. Results: All 32 randomised participants completed the study, and 30 were included in the per-protocol set. The adjusted least-squares mean Lebel Symptom Score was 3.33 after BDNS and 4.30 after isotonic saline. BDNS met the prespecified criterion for non-inferiority and subsequently demonstrated superiority over isotonic saline, with a mean treatment difference of −0.97 points in the per-protocol population (p = 0.026). The analysis in the randomised set yielded consistent findings (mean difference, −0.87 points; p = 0.033). Treatment satisfaction was significantly higher with BDNS for both perceived effectiveness (difference, 0.69; p = 0.007) and tolerability (difference, 0.81; p < 0.001). Overall, 75% of participants preferred BDNS. No serious treatment-emergent adverse events or serious adverse device effects occurred, and no device deficiencies were reported. Conclusions: In adults with pollen-induced allergic rhinitis, BDNS was non-inferior and, following hierarchical testing, superior to 0.9% isotonic saline with respect to post-provocation symptom severity after 7 days of treatment. BDNS was well tolerated and was associated with greater participant satisfaction and a clear treatment preference. These findings support the favourable short-term clinical per-formance and acceptability of BDNS under controlled allergen-challenge conditions.