A prospective, randomized, double-blind, placebo-controlled, multicenter clinical trial to evaluate the efficacy and safety of subcutaneous immunotherapy with polymerized grass pollen extracts in patients with grass pollen–induced allergic rhinitis/rhinoconjunctivitis with or without mild-to-moderate asthma

Grass pollen induced moderate-to-severe allergic rhinitis or rhinoconjunctivitis with or without mild-to-moderate asthma

The clinical impact of 6-grass pollen polymerized extract, 30,000 TU/mL, and 6-grass pollen polymerized extract, 10,000 TU/mL will be assessed by comparing the mean daily Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score (RCSMS, according to the scoring system described by Pfaar et al) (1) over the peak grass pollen season between the 30,000 TU/mL group and placebo, and between the 10,000 TU/mL group and placebo, using the participant’s diary (ITK Diary Card application).

Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score (RCSMS) during the entire grass pollen season (comparison between each active treatment group and placebo)., Rhinitis/Rhinoconjunctivitis Symptom Score (RSS) during the peak and entire grass pollen season (comparison between each active treatment group and placebo)., Rhinitis/Rhinoconjunctivitis Medication Score (RMS) during the peak and entire grass pollen season (comparison between each active treatment group and placebo)., Asthma-Combined Symptom and Medication Score (ACSMS) during the peak and entire grass pollen season (comparison between each active treatment group and placebo)., Asthma Symptom Score (ASS) during the peak and entire grass pollen season (comparison between each active treatment group and placebo)., Asthma Medication Score (AMS) during the peak and entire grass pollen season (comparison between each active treatment group and placebo)., Asthma and Rhinitis/Rhinoconjunctivitis Symptom Score (ARSS) during the peak and entire grass pollen season (comparison between each active treatment group and placebo)., Asthma and Rhinitis/Rhinoconjunctivitis Medication Score (ARMS) during the peak and entire grass pollen season (comparison between each active treatment group and placebo)., Asthma and Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score (ARCSMS) during the peak and entire grass pollen season (comparison between each active treatment group and placebo)., Differences between placebo- and each active treatment group (30,000 TU/mL and 10,000 TU/mL) in asthma control as assessed by the GINA 2026 Asthma Control Questionnaire before the start of treatment (Scr) and at the peak grass pollen season (O2)., Differences between placebo and each active treatment group (30,000 TU/mL and 10,000 TU/mL) in health-related quality of life (Rhinitis/Rhinoconjunctivitis Quality of Life Questionnaire – RQLQ and Visual Analogue Scale – VAS) before the start of treatment (Scr) and at the peak grass pollen season (O2)., Comparison of the mean number of well-days (days without symptoms and without use of rescue medication) during the peak and entire grass pollen season between placebo and each active treatment group (30,000 TU/mL and 10,000 TU/mL)., Comparison of asthma exacerbations during the trial, from T1 to EoT, between placebo and each active treatment group (30,000 TU/mL and 10,000 TU/mL), including time to first asthma exacerbation, number, duration, severity, and association with rhinitis and/or rhinoconjunctivitis., Comparison of the number of allergy related healthcare contacts during the study between placebo and each active treatment group (30,000 TU/mL and 10,000 TU/mL), including general practitioner visits, unscheduled specialist visits, emergency room visits, hospitalizations, and telephone contacts with the doctor, Comparison of changes in specific immunoglobulins IgE, and IgG4 against grass pollen allergens and/or components of the grass pollen mixture between placebo and each active treatment group, 30,000 TU/mL and 10,000 TU/mL, from before treatment, (Scr), to after treatment (O1), and to the End-of-Trial visit (EoT)., Comparison of changes in allergen sensitisation using ALEX technology between placebo and each active treatment group, 30,000 TU/mL and 10,000 TU/mL, from before treatment (Scr), to after treatment (O1), and to the End-of-Trial visit (EoT)., Treatment-emergent adverse events o Measurable and unmeasurable local reactions at the injection site o Systemic reactions. o Unexpected adverse events, Physical examinations and vital signs., Laboratory investigations (blood count, clinical chemistry, renal and liver function-related parameters) before (Scr) and after treatment (O1)., Pulmonary function testing for participants with obstructive or restrictive ventilation disorders., Use of rescue medication during the treatment phase.

No related papers found yet.