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3.
J Allergy Clin Immunol ; 143(3): 1058-1066.e6, 2019 03.
Artículo en Inglés | MEDLINE | ID: mdl-30654054

RESUMEN

BACKGROUND: The SQ tree sublingual immunotherapy (SLIT)-tablet (ALK-Abelló, Hørsholm, Denmark) is developed for treatment of tree pollen-induced allergic rhinoconjunctivitis (ARC). OBJECTIVE: The aim of this pivotal phase III trial was to demonstrate the efficacy and safety of the SQ tree SLIT-tablet. METHODS: This was a randomized, double-blind, placebo-controlled trial with 634 subjects (12-65 years) with moderate-to-severe ARC despite use of symptom-relieving medication. Eligible subjects were randomized 1:1 to active or placebo treatment. The primary end point was the average daily ARC total combined score (TCS) during the birch pollen season (BPS) analyzed for subjects with diary data during the BPS. Secondary end points included average daily symptom scores (DSS) during the BPS, average TCS and DSS during the tree pollen season (TPS), and average daily medication scores (DMS) in the BPS and TPS. RESULTS: The primary and key secondary end points demonstrated statistically significant and clinically relevant effects of the SQ tree SLIT-tablet compared with placebo. For the BPS, absolute (relative) differences from placebo were 3.02 (40%) for TCS, 1.32 (37%) for DSS, and 1.58 (49%) for DMS (all P < .0001). For the TPS, absolute (relative) differences from placebo were 2.27 (37%) for TCS, 0.99 (33%) for DSS, and 1.20 (47%) for DMS (all P < .0001). Treatment was well tolerated. The most frequently reported treatment-related adverse events were mild or moderate local reactions related to sublingual administration. CONCLUSION: The trial demonstrated the efficacy and safety of the SQ tree SLIT-tablet compared with placebo during the BPS and TPS in adolescents and adults with birch pollen-induced ARC (EudraCT 2015-004821-15).


Asunto(s)
Alérgenos/inmunología , Betula/inmunología , Conjuntivitis Alérgica/terapia , Polen/inmunología , Rinitis Alérgica Estacional/terapia , Inmunoterapia Sublingual/métodos , Adolescente , Adulto , Anciano , Niño , Método Doble Ciego , Humanos , Persona de Mediana Edad , Comprimidos , Resultado del Tratamiento , Adulto Joven
4.
Clin Ther ; 40(4): 574-586.e4, 2018 04.
Artículo en Inglés | MEDLINE | ID: mdl-29551533

RESUMEN

PURPOSE: The SQ tree sublingual immunotherapy (SLIT)-tablet containing allergen extracts with the major allergen Bet v 1 from birch pollen is currently being developed for the treatment of tree pollen-induced allergic rhinitis/conjunctivitis with or without asthma. The aim of this Phase II trial was to investigate the dose-related efficacy and safety of the SQ tree SLIT-tablet. METHODS: This study was a randomized, parallel-group, double-blind, placebo-controlled, multi-national trial conducted in Europe. A total of 637 participants were randomized equally to receive placebo or treatment with the SQ tree SLIT-tablet in doses of 0.5, 1, 2, 4, 7, or 12 development units (DU). Treatment was initiated ~16 weeks before onset of the 2013 birch pollen season (BPS) and was continued throughout the BPS with a total duration of at least 6 months. During the BPS and tree pollen season (TPS), subjects assessed rhinoconjunctivitis symptoms and medication use on a daily basis in an electronic diary; weekly assessments of rhinoconjunctivitis quality of life were also made. FINDINGS: Analysis of the average daily symptom score during the BPS and the TPS showed that the difference between active treatment and placebo was statistically significant for the 7 DU group (BPS, P = 0.02; TPS, P = 0.03), with no clear dose-response relationship. All doses of the SQ tree SLIT-tablet induced changes from baseline in birch-specific IgE and IgG4 that were statistically significant compared with placebo at all time points assessed (P < 0.0001) with a clear dose-response relationship for birch specific IgG4. In general, the SQ tree SLIT-tablet was well tolerated, with the majority of treatment-related adverse events (≥95%) being mild or moderate in severity. The most frequently reported treatment-related adverse events were generally related to the sublingual administration of the tablet (ie, they occurred in the oral cavity). IMPLICATIONS: The results from this trial suggest that the SQ tree SLIT-tablet in doses up to 12 DU has a tolerability profile suitable for at-home administration. The immunomodulatory changes indicate a dose-response relationship, but clinical efficacy parameters were inconclusive, probably due to low pollen counts, emphasizing the importance of pollen exposure for the outcome of a pollen allergy immunotherapy trial. EudraCT no: 2012-000031-59.


Asunto(s)
Conjuntivitis Alérgica/terapia , Rinitis Alérgica Estacional/inmunología , Rinitis Alérgica/terapia , Inmunoterapia Sublingual/métodos , Adolescente , Adulto , Anciano , Alérgenos/inmunología , Asma/epidemiología , Niño , Método Doble Ciego , Europa (Continente) , Femenino , Humanos , Masculino , Persona de Mediana Edad , Polen/inmunología , Calidad de Vida , Estaciones del Año , Comprimidos , Resultado del Tratamiento , Árboles/inmunología , Adulto Joven
5.
Am J Rhinol Allergy ; 31(1): 19-28, 2017 Jan 09.
Artículo en Inglés | MEDLINE | ID: mdl-28234147

RESUMEN

BACKGROUND: Intranasal corticosteroids (INS) (corticosteroid nasal sprays) and oral antihistamines (OA) are two of the most common treatments for patients with allergic rhinitis (AR). To our knowledge, there are no systematic reviews on this topic including trials published after 2007. OBJECTIVE: To compare INS with nonsedating OAs as treatments for AR. METHODS: The systematic review and meta-analysis were based on the Grades of Recommendation, Assessment, Development, and Evaluation principles and the Patient, Intervention, Comparison, and Outcome approach. Primary literature was searched up to January 22, 2015. Criteria for eligibility were randomized controlled trials that compared the efficacy and/or adverse effects of INS and OA in patients with AR. Continuous outcome data were analyzed by using standardized mean differences (SMD) for multiple outcome measures, and mean differences in the case of a single study or outcome. Pooled estimates of effects, 95% confidence interval (CI), were calculated by using random-effects models. RESULTS: The meta-analysis included five randomized controlled trials with a total of 990 patients. INS were superior to OAs in improving total nasal symptoms score (SMD -0.70 [95% CI, -0.93 to -0.47]) and in relieving the following: nasal obstruction (SMD -0.56 [95% CI, -0.82 to -0.29]), rhinorrhea (SMD -0.47 [95% CI, -1.00 to 0.05]), nasal itching (SMD -0.42 [95% CI, -0.65 to -0.18]), sneezing (SMD -0.52 [95% CI, -0.73 to -0.32]), and quality of life mean difference -0.90 [95% CI, -1.18 to -0.62]). There was no difference in relief of ocular symptoms (SMD -0.08 [95% CI, -0.23 to 0.08]). In addition, four randomized controlled trials were included in a narrative analysis. The results in the narrative analysis were comparable with those found in the meta-analysis. CONCLUSION: INS were superior to OAs in improving nasal symptoms and quality of life in patients with AR.


Asunto(s)
Corticoesteroides/administración & dosificación , Rinitis Alérgica/tratamiento farmacológico , Administración Intranasal , Administración Oral , Humanos , Calidad de Vida , Resultado del Tratamiento
6.
Contact Dermatitis ; 76(3): 160-166, 2017 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-28090651

RESUMEN

BACKGROUND: Hairdressing is one of the professions with the highest risk of occupational skin and respiratory diseases. The incidence of these diseases in hairdressing apprentices has been studied only sparsely. OBJECTIVE: To determine the incidence of skin and respiratory diseases in hairdressing apprentices, and to explore whether hairdressing apprentices leave the trade during training because of these diseases. METHODS: A 3-year follow-up questionnaire study was conducted among 248 hairdressing apprentices and a control group comprising 816 young adults from the general population. RESULTS: The incidence rate ratios (IRRs) for contact urticaria (IRR 4.7, 95%CI: 2.6-8.6), hand eczema (IRR 1.7, 95%CI: 1.1-2.6) and rhinitis symptoms (IRR 1.6, 95%CI: 1.2-2.2) were significantly increased in the hairdressing apprentices, whereas wheezing was similar between groups. During the follow-up period, 21.8% of the hairdressing apprentices had left the trade, and 70.3% of these had left because of health complaints. The most frequently reported reasons for leaving were musculoskeletal pain (47.4%) and skin diseases (47.4%), followed by respiratory symptoms (23.7%). CONCLUSIONS: Hairdressing apprentices are at increased risk for contact urticaria, hand eczema and rhinitis symptoms compared with the general population, and a substantial proportion leave the trade because of these diseases, causing a 'healthy worker survivor effect.'


Asunto(s)
Industria de la Belleza/educación , Dermatitis por Contacto/epidemiología , Dermatitis Profesional/epidemiología , Exposición Profesional/efectos adversos , Trastornos Respiratorios/epidemiología , Adulto , Dinamarca , Femenino , Preparaciones para el Cabello/efectos adversos , Humanos , Incidencia , Masculino , Exposición Profesional/estadística & datos numéricos , Prevalencia , Adulto Joven
7.
Int Forum Allergy Rhinol ; 7(1): 43-49, 2017 01.
Artículo en Inglés | MEDLINE | ID: mdl-27513701

RESUMEN

BACKGROUND: Little is known about the occurrence of respiratory symptoms among hairdressing apprentices during their training. Therefore, in this study, we examined whether hairdressing apprentices are at increased risk of rhinitis and asthma symptoms when compared with other young adults from the general population. METHODS: A questionnaire was completed by 504 hairdressing apprentices and 1400 control participants from the general population with a similar age, gender, and geographic distribution. RESULTS: The 1-year prevalence of rhinitis symptoms was higher in hairdressing apprentices than in controls (58.1% vs 46.6%; odds ratio, 1.59; 95% confidence interval, 1.30-1.98), and the prevalence was higher among hairdressing apprentices in the last years of training compared with apprentices in the first year of training (62.4% vs 41.8%, p = 0.003). Current smoking was more common in hairdressing apprentices (28.4% vs 17.2%, p < 0.001). Asthma symptoms were equally common in the 2 groups; however, hairdressing apprentices had a later age of onset of wheezing than did the controls (18 years vs 14 years, p < 0.00001) and a decreased risk of wheezing (odds ratio, 0.72; 95% confidence interval, 0.54 to 0.95) after adjusting for smoking, education level, and degree of rurality. Bleaching products were the most frequently reported cause of rhinitis and asthma symptoms in hairdressing apprentices. CONCLUSIONS: Hairdressing apprentices seem to have an increased risk of occupational rhinitis, and bleaching products are the main cause of respiratory symptoms. In addition, our findings suggest that a healthy worker effect exists in relation to asthma among hairdressing apprentices.


Asunto(s)
Preparaciones para el Cabello/efectos adversos , Enfermedades Profesionales/epidemiología , Rinitis/epidemiología , Adolescente , Adulto , Asma/epidemiología , Asma/etiología , Dinamarca/epidemiología , Femenino , Humanos , Masculino , Enfermedades Profesionales/etiología , Exposición Profesional , Oportunidad Relativa , Prevalencia , Rinitis/etiología , Fumar/epidemiología , Adulto Joven
8.
Contact Dermatitis ; 72(1): 40-6, 2015 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-25381756

RESUMEN

BACKGROUND: Hairdressers are at risk for occupational skin diseases. Since 2008, an educational programme has been conducted in Danish hairdressing schools to prevent occupational skin diseases. Its effect is unknown. OBJECTIVE: To examine the current frequency of self-reported hand eczema and contact urticaria in Danish hairdressing apprentices as compared with controls, and to determine the occurrence of hand eczema and contact urticaria in hairdressing apprentices with different durations of exposure to the trade. METHODS: This was a cross-sectional, web-based questionnaire study conducted among 504 hairdressing apprentices and a control group of 1400 adolescents from the general population. RESULTS: Hand eczema was significantly more prevalent in the hairdressing apprentices than in controls (34.5% versus 18.8%, p < 0.001). The incidence rate of hand eczema among hairdressing apprentices was 98 cases/1000 person-years. Contact urticaria was also more prevalent in the hairdressing apprentices (7.3% versus 4.2%, p = 0.006). Both diseases increased with increasing duration of exposure to the trade. CONCLUSION: Despite educational efforts to prevent occupational skin diseases in the hairdressing schools, Danish apprentices are still at increased risk for hand eczema and contact urticaria. Both diseases develop after only a few years of work in hairdressing. Further preventive strategies are warranted.


Asunto(s)
Industria de la Belleza/educación , Dermatitis por Contacto/epidemiología , Dermatitis Profesional/epidemiología , Dermatosis de la Mano/epidemiología , Adolescente , Adulto , Estudios de Casos y Controles , Estudios Transversales , Dinamarca/epidemiología , Dermatitis por Contacto/prevención & control , Dermatitis Profesional/prevención & control , Femenino , Dermatosis de la Mano/prevención & control , Humanos , Incidencia , Masculino , Prevalencia , Encuestas y Cuestionarios , Adulto Joven
9.
Ugeskr Laeger ; 176(25A)2014 Dec 15.
Artículo en Danés | MEDLINE | ID: mdl-25497633

RESUMEN

Only four cases of anaphylaxis triggered by polyhexanide have been reported in the literature. We report a case of anaphylaxis in a Danish patient treated with polyhexanide derivate (Prontosan) wound products. We emphasise the importance of intramuscular injection of adrenaline as part of the treatment protocol in the initial phase of anaphylaxis and stress the importance of being aware of polyhexanide as a potential trigger of anaphylaxis.


Asunto(s)
Anafilaxia/inducido químicamente , Biguanidas/efectos adversos , Desinfectantes/efectos adversos , Anciano , Anafilaxia/patología , Anafilaxia/terapia , Biguanidas/uso terapéutico , Desinfectantes/uso terapéutico , Femenino , Humanos , Úlcera de la Pierna/tratamiento farmacológico
10.
Ugeskr Laeger ; 169(7): 583-6, 2007 Feb 12.
Artículo en Danés | MEDLINE | ID: mdl-17311749

RESUMEN

Allergic diseases are prominent, possibly life threatening, and a cause of worldwide concern. Evidence-based education of doctors in the specialty of allergology is a prerequisite for correct diagnosis and treatment of patients with allergic diseases. Recently, the specialty of allergology has been abolished in Denmark, without any upgrading of the education of doctors in related specialties. As a consequence, one could fear that allergy expertise will be disappearing. We propose collaboration among experts from related specialties with joint mediation of knowledge through a centre of allergology, common educational programs for doctors in training and physician specialists, and collaboration in regional centres of allergology.


Asunto(s)
Alergia e Inmunología , Alergia e Inmunología/educación , Alergia e Inmunología/organización & administración , Alergia e Inmunología/normas , Competencia Clínica , Dinamarca , Educación de Postgrado en Medicina , Medicina Basada en la Evidencia , Humanos , Hipersensibilidad/diagnóstico , Hipersensibilidad/terapia , Medicina/organización & administración , Especialización
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