BACKGROUND:
Critical examination of the quality and validity of available allergic rhinitis (AR) literature is necessary to improve understanding and to appropriately translate this knowledge to clinical care of the AR patient. To evaluate the existing AR literature, international multidisciplinary experts with an interest in AR have produced the International Consensus statement on Allergy and Rhinology: Allergic Rhinitis (ICAR:AR).
METHODS:
Using previously described methodology, specific topics were developed relating to AR. Each topic was assigned a literature review, evidence-based review (EBR), or evidence-based review with recommendations (EBRR) format as dictated by available evidence and purpose within the ICAR:AR document. Following iterative reviews of each topic, the ICAR:AR document was synthesized and reviewed by all authors for consensus.
RESULTS:
The ICAR:AR document addresses over 100 individual topics related to AR, including diagnosis, pathophysiology, epidemiology, disease burden, risk factors for the development of AR, allergy testing modalities, treatment, and other conditions/comorbidities associated with AR.
CONCLUSION:
This critical review of the AR literature has identified several strengths; providers can be confident that treatment decisions are supported by rigorous studies. However, there are also substantial gaps in the AR literature. These knowledge gaps should be viewed as opportunities for improvement, as often the things that we teach and the medicine that we practice are not based on the best quality evidence. This document aims to highlight the strengths and weaknesses of the AR literature to identify areas for future AR research and improved understanding.

/pdf/international-consensus-statement-on-allergy-and-rhinology-pnvs6cds27.pdf

International Consensus Statement on Allergy and Rhinology: Allergic Rhinitis.

In the 5 years that have passed since the publication of the 2018 International Consensus Statement on Allergy and Rhinology: Allergic Rhinitis (ICAR‐Allergic Rhinitis 2018), the literature has expanded substantially. The ICAR‐Allergic Rhinitis 2023 update presents 144 individual topics on allergic rhinitis (AR), expanded by over 40 topics from the 2018 document. Originally presented topics from 2018 have also been reviewed and updated. The executive summary highlights key evidence‐based findings and recommendation from the full document.

https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/alr.23090

International consensus statement on allergy and rhinology: Allergic rhinitis – 2023

Clinical efficacy of probiotic Bifidobacterium longum for the treatment of symptoms of Japanese cedar pollen allergy in subjects evaluated in an environmental exposure unit.

Summary
Background Efficacy testing of drugs in seasonal allergic rhinitis (SAR) is often disturbed by seasonal variations of environmental allergens, and assessment of onset and duration of action is hardly possible under natural conditions. Allergen provocation in an environmental challenge chamber (ECC) can be of added value in this respect. However, the specificity, sensitivity, and reproducibility of outcome measures under both settings are unclear.

Objective The aim of this study was to investigate and compare the diagnostic value (specificity, sensitivity, and reproducibility) of clinical end-points and biomarkers both following allergen provocation in an ECC and under natural conditions.

Methods Sixty adult patients with SAR to grass and 60 healthy subjects were exposed twice to grass pollen in an ECC and observed twice during the pollen season. Symptoms, nasal flow, as well as exhaled and nasal nitric oxide (NO) were investigated.

Results The total nasal symptom score (TNSS) in the ECC had the best reproducibility (intraclass correlation coefficient ICC=0.86) and sensitivity/specificity [area under receiver operating characteristic curve (AUC)=0.99] of all measures. Symptoms in season also had good sensitivity/specificity but were far less reproducible. Nasal flow in the ECC had good sensitivity/specificity but reproducibility was limited. NO measurements showed good reproducibility but sensitivity/specificity were limited, except for exhaled NO in season (AUC=0.75).

Conclusion The high reproducibility and sensitivity/specificity in the ECC suggests that TNSS is a valuable outcome measure. While exhaled NO can be considered to monitor airway inflammation, nasal NO appears to be unspecific.

Cite this as: J. M. Hohlfeld, T. Holland-Letz, M. Larbig, M. Lavae-Mokhtari, E. Wierenga, M. Kapsenberg, R. van Ree, N. Krug and A. Bufe, Clinical & Experimental Allergy, 2010 (40) 998–1006.

Diagnostic value of outcome measures following allergen exposure in an environmental challenge chamber compared with natural conditions.

Summary
Allergic rhinitis (AR) is a common condition with quality of life and economic implications for those affected. Numerous studies have attempted to evaluate treatments for rhinitis, seeking clinically meaningful efficacy and safety results to enable evidence-based treatment decisions. Traditional studies of medications for AR are hampered by many confounding environmental factors as well as suboptimal medication compliance. They are also an unsuitable setting for determination of precise pharmacodynamic properties of medications, including onset and duration of action. Allergen challenge chambers (ACCs) were developed to provide predetermined, controlled allergen levels and to limit variables inherent in traditional studies. An ACC hosts a number of allergen-sensitive subjects who may receive either medication or placebo in a closed environment regulated for temperature, humidity and other variables. Subjects' allergic responses are monitored using subjective and objective assessments throughout the study, and the resultant information contributes significantly to the clinical profile of a medication. This consensus paper provides an in-depth review of the role of ACCs as a means to evaluate treatments in AR, and concludes that ACC trials fulfil an important supportive role in the assessment of anti-allergic medication.

The role of allergen challenge chambers in the evaluation of anti‐allergic medication: an international consensus paper

Background: Loteprednol etabonate (LE) is a novel soft steroid that was designed to improve the benefit/risk ratio of topical corticosteroid therapy. This study assesses the clinical efficacy and safety of three different doses of LE nasal spray in seasonal allergic rhinitis (SAR).



Methods:  In this single-center, double-blind, placebo-controlled, parallel-group trial 165 subjects with SAR to grass pollen received daily single doses of either 100, 200, 400 μg LE nasal spray, or placebo for 14 days. The patients underwent three 4-h allergen challenges with grass pollen in an environmental exposure unit at a screening visit (baseline) and on days 7 and 14 of treatment. Standardized nasal symptom scores were obtained every 20 min. Nasal flow, nasal secretions, and FEV1 were measured every hour during allergen challenges.



Results:  After 14 days of treatment, patients who received 400 μg LE had significantly lower total nasal symptom scores compared with those receiving placebo (P = 0.007). LE400 reduced rhinorrhea, nasal congestion, nasal itching, the amount of nasal secretions, and improved nasal flow as compared with placebo (P < 0.05). LE100 and LE200 were not significantly different from placebo. All treatments were well tolerated.



Conclusions:  Loteprednol 400 μg once daily is superior to placebo and the only effective dose tested in improving nasal symptoms and objective parameters in patients with SAR.

Effect of loteprednol etabonate nasal spray suspension on seasonal allergic rhinitis assessed by allergen challenge in an environmental exposure unit.

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Effect of loteprednol etabonate nasal spray suspension on seasonal allergic rhinitis assessed by allergen challenge in an environmental exposure unit.