HAMBURG, Germany, June 11, 2023 /PRNewswire/ -- A study conducted by researchers from the ALL-MED Medical Research Institute and the Department of Clinical Immunology at Wroclaw Medical University in Poland has validated the use of an allergen exposure chamber (AEC) in assessing the clinical outcomes of house dust mite (HDM) allergen immunotherapy (AIT) in patients with allergic rhinoconjunctivitis.
The study focused on evaluating the efficacy and safety of AEC-derived clinical outcomes of subcutaneous HDM AIT, a treatment designed to alleviate symptoms triggered by HDM allergies. Fifty patients with HDM-triggered allergic rhinoconjunctivitis were included in the study, with HDM allergy confirmed through various diagnostic tests such as skin prick tests, serum-specific IgE, and basophil activation tests.
During the study, patients were assessed in the allergen exposure chamber before commencing AIT and after 12 months of treatment. The chamber provided a controlled environment, allowing patients to be exposed to HDM allergen under stable and well-regulated conditions. Various clinical endpoints, including total nasal symptom score (TNSS), visual analog scale (VAS), and objective parameters such as acoustic rhinometry, peak nasal inspiratory flow (PNIF), and nasal secretion weight, were used to assess the effectiveness of AIT.
The results of the study demonstrated a statistically significant reduction in TNSS (p<0.005) after one year of AIT, indicating the positive impact of the treatment on nasal symptoms. There was a high reduction in nasal symptoms observed using other objective parameters (PNIF, nasal secretion, acoustic rhinometry-MCA). These findings suggest the potential of AEC as a valuable tool for data collection, proof-of-concept studies, and biomarker analysis.
"The study findings demonstrate that the Allergen Exposure Chamber (AEC) challenge is consistent and safe, allowing researchers to collect data quickly and of high quality. Moreover, the results indicate that the clinical measurements obtained in the AEC align well with the effectiveness evaluation using the Combined Symptom and Medication Score (CSMS) in real-life conditions. This suggests that the AEC could serve as an alternative to traditional trial designs. Specifically, the Total Nasal Symptom Score (TNSS) measured in the AEC is identified as a reliable primary endpoint in clinical trials. However, nasal provocation tests (NPT) may not be suitable as a primary endpoint since they do not correlate well with CSMS in real-life conditions and TNSS in the AEC", says Professor Marek Jutel from Wroclaw.
The researchers emphasize the importance of further validating clinical endpoints using immunological biomarkers for the continued development and application of AEC in clinical trials. The study also suggests that accelerated dose escalation of native HDM AIT is both safe and convenient. A movie on Allergen Chamber test is available here: https://review.jove.com/v/64801?status=a66807k
In conclusion, the study confirms that the allergen exposure chamber challenge is an effective, reproducible, and safe method for assessing the outcomes of HDM AIT in patients with allergic rhinoconjunctivitis. Ongoing research is being conducted to validate clinical endpoints using immunological biomarkers, offering promising prospects for improved diagnostic and treatment approaches.
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