2023-06-11 20:06:03
Hamburg, Germany, June 12 /PRNewswire/ – A study conducted by researchers from the ALL-MED Medical Research Institute and the Department of Clinical Immunology at the Medical University of Wroclaw in Poland evaluated the use of an Allergen Exposure Chamber (AEC) to evaluate the clinical outcomes of allergen House dust mite (HDM) immunotherapy (AIT) validated 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 caused by HDM allergy. Fifty patients with HDM allergic rhinoconjunctivitis were included in the study, with HDM allergy confirmed by various diagnostic tests such as skin prick tests, serum-specific IgE and basophil activation tests.
During the study, patients were examined in the allergen exposure chamber before starting AIT and after 12 months of treatment. The chamber provided a controlled environment in which patients could be exposed to the HDM allergen under stable and well-regulated conditions. Various clinical endpoints were used to assess the effectiveness of AIT, including the Total Nasal Symptom Score (TNSS), the Visual Analog Scale (VAS) and objective parameters such as acoustic rhinometry, peak nasal inspiratory flow (PNIF) and the weight of nasal secretion.
The results of the study showed a statistically significant reduction in TNSS (p<0.005) after one year of AIT, indicating the beneficial effect of treating nasal symptoms. There was a high decrease in nasal symptoms observed with other objective parameters (PNIF, nasal secretion, acoustic rhinometry-MCA). These results suggest the potential of AEC as a valuable tool for data collection, proof of concept studies, and biomarker analysis.
“The study results show that testing in the Allergen Exposure Chamber (AEC) is consistent and safe, allowing researchers to collect timely and high-quality data. In addition, the results indicate that the clinical measurements in the AEC agree well with the efficacy assessment using the Combined Symptom and Medication Score (CSMS) in real-world conditions. This suggests that the AEC could serve as an alternative to traditional test forms. In particular, 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 because they do not correlate well with CSMS in real-world conditions and TNSS in the AEC,” Professor said Mark Jutel in Breslau.
Researchers emphasize the importance of further validation of 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 practical. A film of the allergen chamber test is available here:
In conclusion, the study confirms that the allergen exposure chamber challenge is an effective, reproducible, and safe method to evaluate the outcomes of HDM AIT in patients with allergic rhinoconjunctivitis. Research is currently underway to validate clinical endpoints using immunological biomarkers, which offers promising prospects for improved diagnostic and treatment approaches.
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The European Academy of Allergy and Clinical Immunology (EAACI) is an association of treating physicians, researchers and health professionals, established in 1956. The EAACI is committed to improving health of people affected by allergic diseases. With more than 15,000 members from 125 countries and over 75 national allergy associations, the EAACI is the main source of expertise in Europe and worldwide to all aspects of allergies.
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