338 research outputs found
Early detection of allergic diseases in otorhinolaryngology
Asthmatic diseases have been reported since the ancient world. Hay fever for instance, was described for the first time in the late 18th century, and the term “allergy” was introduced about 100 years ago. Today the incidence of allergies is rising; almost one third of the Western population suffers from its side effects. Allergies are some of the most chronic medical complaints, which results in high health expenditures. Therefore, they have a large health and political relevance
Early detection of allergic diseases in otorhinolaryngology
Asthmatic diseases have been reported since the ancient world. Hay fever for instance, was described for the first time in the late 18th century, and the term “allergy” was introduced about 100 years ago. Today the incidence of allergies is rising; almost one third of the Western population suffers from its side effects. Allergies are some of the most chronic medical complaints, which results in high health expenditures. Therefore, they have a large health and political relevance
Efficacy and tolerability of levocabastine and azelastine nasal sprays for the treatment of allergic rhinitis
Levocabastine and azelastine are currently the only antihistamines available as nasal sprays for the topical therapy of seasonal allergic rhinitis. The present study was undertaken to compare the onset of action, efficacy and tolerability of these two agents in a total of 242 patients with this condition. This was an international, multicentre, open-label, randomized, parallel-group trial with 123 patients treated with levocabastine (0.5 mg/ml, two puffs per nostril twice daily) and 119 with azelastine (1 mg/ml, one puff per nostril twice daily). Onset of action was comparable for the two drugs with over 50% of patients in each group reporting significant symptomatic relief within 30 min of administration of the first dose of study medication. Therapeutic efficacy was also found to be comparable in the two groups with no statistically significant intergroup differences reported for any of the parameters evaluated, although assessments of global therapeutic efficacy revealed a trend favouring levocabastine. Levocabastine appeared to be better tolerated than azelastine (p = 0.06), with the incidence of the most common adverse experiences, application site reactions and taste disturbances, significantly higher on azelastine than with levocabastine (5% versus 1%; p = 0.05 and 5% versus 0%; p = 0.01, respectively). In conclusion, levocabastine nasal spray appears to be at least as effective as, but better tolerated than, azelastine nasal spray for the treatment of seasonal allergic rhinitis
A survey among members of the Association of German Allergists (AeDA)
Background: The severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) pandemic presented unprecedented challenges to both inpatient and outpatient care. In order to maintain good care under necessary contact restrictions, especially in the outpatient sector, the use of telemedical applications was demanded and promoted. The exploratory survey among members of the Association of German Allergists (AeDA) was intended to show how these were received among allergists in private practice.
Methods: The survey was restricted to actively practising members of the AeDA who had previously given their consent to receive such surveys (n = 437). They were invited by email to participate in a survey on the topic of "Telemedicine in everyday clinical practice in allergology". The survey included quantitative and qualitative questions on the use of telemedicine services before and during the pandemic and was conducted anonymously on the SoSci Survey platform. Participation was possible in the period from June to August 2020.
Results: In all, 76 specialists with additional qualification in allergology took part in the survey. Of these, 71 completed the full questionnaire. Before the start of the pandemic-related contact restrictions, 46.5% (33/71) stated that they had used telemedicine in their clinical practice. This number increased to 73.2% (52/71) after 31 January 2020. The largest increase (4.3% vs. 15.6%) was seen in the area of video consultations. Furthermore, 43/76 participants can imagine integrating telemedicine services into their daily clinical routine in the future.
Conclusion: The use of telemedical services, especially video consultations, increased significantly during the SARS-CoV‑2 pandemic in Germany. The majority of respondents perceive the implementation as positive and can imagine continuing to use telemedical methods after the end of the pandemic
Validity, reliability, and responsiveness of daily monitoring visual analog scales in MASK-air®
Rinitis alérgica; Salud móvil; Escalas analógicas visualesRinitis al·lèrgica; Salut mòbil; Escales analògiques visualsAllergic rhinitis; Mobile health Visual analog scalesBackground
MASK-air® is an app that supports allergic rhinitis patients in disease control. Users register daily allergy symptoms and their impact on activities using visual analog scales (VASs). We aimed to assess the concurrent validity, reliability, and responsiveness of these daily VASs.
Methods
Daily monitoring VAS data were assessed in MASK-air® users with allergic rhinitis. Concurrent validity was assessed by correlating daily VAS values with those of the EuroQol-5 Dimensions (EQ-5D) VAS, the Control of Allergic Rhinitis and Asthma Test (CARAT) score, and the Work Productivity and Activity Impairment Allergic Specific (WPAI-AS) Questionnaire (work and activity impairment scores). Intra-rater reliability was assessed in users providing multiple daily VASs within the same day. Test–retest reliability was tested in clinically stable users, as defined by the EQ-5D VAS, CARAT, or “VAS Work” (i.e., VAS assessing the impact of allergy on work). Responsiveness was determined in users with two consecutive measurements of EQ-5D-VAS or “VAS Work” indicating clinical change.
Results
A total of 17,780 MASK-air® users, with 317,176 VAS days, were assessed. Concurrent validity was moderate–high (Spearman correlation coefficient range: 0.437–0.716). Intra-rater reliability intraclass correlation coefficients (ICCs) ranged between 0.870 (VAS assessing global allergy symptoms) and 0.937 (VAS assessing allergy symptoms on sleep). Test–retest reliability ICCs ranged between 0.604 and 0.878—“VAS Work” and “VAS asthma” presented the highest ICCs. Moderate/large responsiveness effect sizes were observed—the sleep VAS was associated with lower responsiveness, while the global allergy symptoms VAS demonstrated higher responsiveness.
Conclusion
In MASK-air®, daily monitoring VASs have high intra-rater reliability and moderate–high validity, reliability, and responsiveness, pointing to a reliable measure of symptom loads.The study was funded by ARIA. Open access funding enabled and organized by Projekt DEAL
A position paper of the Association of German Allergists (AeDA)
Since spring 2020, the wide-ranging contact restriction measures in the context of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic have also led to a reduction in physician-patient contacts in the ambulatory care setting. Telemedicine applications will increasingly provide a way to efficiently deliver patient care under infection control measures. In allergology, telemedical as well as digital applications can also significantly facilitate everyday clinical practice. However, the technical and legal hurdles associated with the implementation of digital strategies must be overcome for this to happen. The aim of this article is to provide an intuitive overview of the aspects to be considered in the implementation of telemedicine consultations and to highlight the current state of the framework as well as optimization possibilities and perspectives in allergology. If a structured use is guaranteed, digital and telemedical applications can improve patient care-also in allergology. There is potential to be exploited in many areas, from the remote collection of clinical history, and video consultations, to the discussion of diagnostic findings, disease monitoring, and therapy support. The use of telemedical applications, especially video consultations, has experienced a remarkable acceleration in the context of the coronavirus disease 2019 (COVID-19) pandemic. The present overview of the legal, technical and professional framework is intended to support the anchoring of digital and telemedical technologies in everyday allergology. However, in order to consolidate these in the future, an agreement is needed regarding professional standards of action as well as a remuneration structure that is permanently defined beyond the current pandemic
A prospective study comparing the efficacy and safety of two sublingual birch allergen preparations
Background: SUBLIVAC FIX Birch (SUB-B) is a liquid oral preparation of Betula verrucosa pollen extract for the treatment of allergic rhinitis/rhinoconjuctivitis induced by birch pollen. The major allergen content of SUB-B and Staloral Birch (Stal-B) have been shown to be comparable. In order to compare the clinical efficacy and safety of both products, the present study was designed to investigate efficacy of treatment with SUB-B compared to Stal-B by means of reduction in allergy symptoms assessed by a titrated nasal provocation test (TNPT) in subjects suffering from IgE mediated allergy complaints triggered by birch pollen. Methods: A prospective, randomized, open, blinded endpoint (PROBE), controlled, single-centre study in 74 birch allergic adults was performed. Treatment consisted of either SUB-B (10,000 AUN/ml) or Stal-B (initial phase 10 I. R./ml and maintenance phase 300 I. R./ml) for 16-20 weeks at maintenance dose. The primary efficacy outcome was defined by the difference in change of the TNPT-threshold dose between the two treatment groups at baseline and after completion of treatment. Secondary outcomes included determination of birch pollen specific IgE and IgG levels, safety lab and ECG. During the first 30 days of treatment, subjects were requested to fill out a diary concerning compliance with study medication, occurrence of AEs and the use of concomitant medication. Results: Analysis of the primary efficacy parameter showed that the percentage of subjects showing a beneficial treatment effect was similar in both treatment groups, 33.3% for SUB-B vs. 31.4% for Stal-B in the intention to treat population. Evaluation of the immunologic response, showed that treatment with SUB-B and Stal-B induced similar increases (approximately 2 times) in IgE, IgG and IgG(4) specific for Bet v 1. In total, 143 related adverse events (AEs) were reported. The majority of the AEs was of mild intensity. The same pattern of AEs was observed for both products. No clinically relevant changes in other safety parameters, such as safety laboratory parameters, vital signs, physical examination and ECGs were observed. Conclusion: Taken together, treatment with both products was effective by means of reduction in allergic symptoms during a TNPT. In addition, safety analysis revealed a good tolerability of both SLIT extract
Sublingual allergen immunotherapy with a liquid birch pollen product in patients with seasonal allergic rhinoconjunctivitis with or without asthma
Background: Sublingual allergen immunotherapy (SLIT) has been demonstrated to be both clinically efficacious and safe. However, in line with the current regulatory guidance from the European Medicines Agency, allergen immunotherapy (AIT) products must demonstrate their efficacy and safety in pivotal phase III trials for registration.
Objective: We sought to investigate the efficacy and safety of sublingual high-dose liquid birch pollen extract (40,000 allergy units native [AUN]/mL) in adults with birch pollen allergy.
Methods: A randomized, double-blind, placebo-controlled, parallel-group multicenter trial was conducted in 406 adult patients with moderate-to-severe birch pollen-induced allergic rhinoconjunctivitis with or without mild-to-moderate controlled asthma. Treatment was started 3 to 6 months before the birch pollen season and continued during the season in 40 clinical study centers in 5 European countries. For primary end point assessment, the recommended combined symptom and medication score of the European Academy of Allergy and Clinical Immunology was used. Secondary end points included quality-of-life assessments, immunologic parameters, and safety.
Results: Primary efficacy results demonstrated a significant (P < .0001) and clinically relevant (32%) reduction in the combined symptom and medication score compared with placebo after 3 to 6 months of SLIT. Significantly better rhinoconjunctivitis quality-of-life scores (P < .0001) and the patient's own overall assessment of his or her health status, including the visual analog scale score (Euro Quality of Life Visual Analogue Scale; P = .0025), were also demonstrated. In total, a good safety profile of SLIT was observed.
Conclusion: This study confirmed both the clinical efficacy and safety of a sublingual liquid birch pollen extract in adults with birch pollen allergy in a pivotal phase III trial (EudraCT: 2013-005550-30; ClinicalTrials. gov: NCT02231307)
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