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Specific Immunotherapy for respiratory allergy is used since about one century and there is now solid documentation of its efficacy. Nevertheless, the methods and experimental designs used in clinical trials are quite heterogeneous and there is no unanimously accepted methodological standard. Many studies are planned with study designs that may not confirm the clinical value of SIT as an effective treatment to reduce disease severity. To ensure that patients are treated based on sound scientific evidence and to minimize the risk of misusing limited financial resources for scientific studies, the World Allergy Organization (WAO) convened a group of experts to provide guidelines for the methodology of future immunotherapy studies. This document summarizes the recommendations for study design, patients’ selection, appropriate outcomes and statistical treatment to be used in planning and performing clinical trials with specific immunotherapy.

Allergic rhinitis (AR) and asthma represent global health problems for all age groups. Asthma and rhinitis frequently coexist in the same subjects. Allergic Rhinitis and its Impact on Asthma (ARIA) was initiated during a World Health Organization workshop in 1999 (published in 2001). ARIA has reclassified AR as mild/moderate-severe and intermittent/persistent. This classification closely reflects patients' needs and underlines the close relationship between rhinitis and asthma. Patients, clinicians, and other health care professionals are confronted with various treatment choices for the management of AR. This contributes to considerable variation in clinical practice, and worldwide, patients, clinicians, and other health care professionals are faced with uncertainty about the relative merits and downsides of the various treatment options. In its 2010 Revision, ARIA developed clinical practice guidelines for the management of AR and asthma comorbidities based on the Grading of Recommendation, Assessment, Development and Evaluation (GRADE) system. ARIA is disseminated and implemented in more than 50 countries of the world. Ten years after the publication of the ARIA World Health Organization workshop report, it is important to make a summary of its achievements and identify the still unmet clinical, research, and implementation needs to strengthen the 2011 European Union Priority on allergy and asthma in children.

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Background: Allergic rhinitis (AR) impairs quality of life (QoL), sleep and work. The Allergic Rhinitis and its Impact on Asthma (ARIA) classification is widely used, but the impact of the different symptoms on QoL is not clear. Objective: To describe characteristics of patients consulting in primary care for AR and to study the impact of AR symptoms and the ARIA classes on QoL. Methods: A multicenter prospective observational cross-sectional study assessed the visual analogue scale (VAS) in the management of AR in 990 patients consulting general practitioners for AR. Patients were classified according to the four classes of ARIA. VAS, Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and total symptom score (TSS) for nasal and non-nasal symptoms were evaluated. VAS and TSS measures were compared with RQLQ. Results: Mild intermittent rhinitis was diagnosed in 20% of patients, mild persistent rhinitis in 17%, moderate/severe intermittent rhinitis in 15% and moderate/severe persistent rhinitis in 48%. The presence of treatments did not affect VAS levels. Both severity and duration of rhinitis had an impact on QoL and VAS levels. Ocular symptoms (OR: 2.78, 95% CI: 1.965–3.939) including eyelid edema (OR: 2.07, 95% CI: 1.274–3.360) and asthenia (OR: 2.73, 95% CI: 1.922–3.877) had more impact on RQLQ than nasal obstruction (OR: 1.61, 95% CI: 1.078–2.405) and nasal pruritus (OR 1.45, 95% CI: 1.028–2.042). Sneezing and rhinorrhea did not impact RQLQ. Conclusions: This study confirmed that ocular symptoms and, to a lesser degree, nasal obstruction and pruritus have a significant impact on QoL.