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Uncontrolled asthma imposes a substantial burden for the individual, the healthcare system and society. Despite of major advances in pharmacotherapy, there has been limited evidence of the potential benefits of regular exercise on asthma control. The aim was to investigate the potential effects of regular exercise on asthma control in adults. Study I is a systematic review and meta-analysis of clinical trials from 1980 to 2011. In Study II, we conducted a population-based cross-sectional study of adults 20–27 years old with asthma (the 20-year follow-up from the Espoo Cohort Study, ECS). In Study III, we conducted a population-based cross-sectional study of adults 17–73 years old with asthma (the Northern-Finnish Asthma Study, NoFAS). In Study IV, we conducted a randomized controlled trial (REACT) to study the effects of a 24-week exercise intervention in adults 16–65 years old with mild to moderate asthma. In the ECS, asthma control was measured by the Asthma Symptom Score (range 0–12, 0 indicating completely controlled asthma). In the NoFAS and the REACT, asthma control was measured by the standardized Asthma Control Test (ACT, range 5–25, 25 indicating completely i.e., very well controlled asthma). Based on the systematic review and meta-analysis, regular exercise improves physical fitness in adults with asthma, but the results on asthma control remained inconclusive. In the ECS, regular exercise reduced the Asthma Symptom Score by 0.09 points per hour of exercise/week (95% CI 0.00 to −0.17). In the NoFAS, asthma control was better among subjects exercising > 5–10 hours a week (ACT = 21.0) compared to the “No exercise” category (ACT = 19.4, difference from the reference group −1.57, 95% CI −2.12 to −1.01). In the REACT, the ACT became better among 62% of the subjects in the exercise group and among 39% in the reference group. The effect of the intervention on improving asthma control was 23% (RD = 0.23, 95% CI 0.109 to 0.492, p = 0.003). In conclusion, adults with asthma benefit from regular exercise which is shown by improving aerobic fitness. Moderate to high regular exercise improves asthma control significantly in adults. A 24-week exercise program improves asthma control measured by the ACT in adults with mild to moderate asthma. Based on these results, regular exercise is recommended to be included in the management of adult asthma. Tiivistelmä Huonossa hoitotasapainossa oleva astma aiheuttaa merkittävää kuormitusta yksilölle, terveydenhuollolle ja yhteiskunnalle. Lääkehoidon kehityksestä huolimatta säännöllisen kuntoliikunnan merkityksestä astman hoidossa on ollut vain vähän tutkimustietoa. Tavoitteena oli tutkia säännöllisen kuntoliikunnan vaikutuksia astman tasapainoon aikuisilla. Ensimmäinen osajulkaisu on systemaattinen kirjallisuuskatsaus ja meta-analyysi kliinisistä kokeista vuosilta 1980–2011. Toinen osajulkaisu on väestöpohjainen poikittaistutkimus 20–27-vuotiailla astmaa sairastavilla (ECS). Kolmas osajulkaisu on väestöpohjainen poikittaistutkimus 17–73-vuotiailla astmaa sairastavilla (NoFAS). Neljäs osajulkaisu on satunnaistettu vertailukoe (REACT), jossa tutkittiin 24 viikon liikuntaohjelman vaikutuksia 16–65-vuotiailla lievää tai keskivaikeaa astmaa sairastavilla. ECS-tutkimuksessa astman tasapainoa mitattiin astmaoirein (Asthma Symptom Score, vaihteluväli 0–12, 0 merkitsee parasta mahdollista astman tasapainoa). NoFAS- ja REACT-tutkimuksissa astman tasapainoa mitattiin standardoidulla Astmatestillä (Asthma Control Test, ACT, vaihteluväli 5–25, 25 merkitsee parasta mahdollista astman tasapainoa). Systemaattisessa kirjallisuuskatsauksessa ja meta-analyysissä todettiin, että säännöllinen kuntoliikunta parantaa astmaa sairastavien fyysistä suorituskykyä, mutta liikunnan vaikutuksista astman tasapainoon ei voitu tehdä vielä johtopäätöksiä. ECS-tutkimuksessa säännöllinen kuntoliikunta vähensi astmaoireita 0,09 pistettä viikossa liikuttua tuntia kohden (95 % LV 0,00…−0,17). NoFAS-tutkimuksessa astman tasapaino oli parempi > 5–10 tuntia viikossa liikkuvien ryhmässä (ACT = 21,0) verrattuna ei lainkaan liikkuvien ryhmään (ACT = 19,4, ero vertailuryhmään −1,57, 95 % LV −2,12…−1,01). REACT-tutkimuksessa ACT parani liikuntaryhmässä 62 %:lla ja vertailuryhmässä 23 %:lla. Liikuntaohjelma paransi astman tasapainoa 23 % (riskiero = 0,23 95 % LV 0,109–0,492, p = 0,003). Astmaa sairastavat aikuiset hyötyvät säännöllisestä kuntoliikunnasta fyysisen suorituskyvyn paranemisen kautta. Kohtalaisesti ja paljon liikkuminen parantaa aikuisten astman tasapainoa. 24-viikon liikuntaohjelma parantaa ACT:llä mitattuna astman tasapainoa lievää tai keskivaikeaa astmaa sairastavilla. Tulosten perusteella suositellaan, että säännöllisen kuntoliikunnan tulisi sisältyä astman omahoito-ohjelmaan aikuisilla.

OBJECTIVE: Psychosocial stress contributes to asthma disparities for low-SES Latinx children, but primary and secondary control coping by children and parents is associated with better psychosocial and asthma outcomes. Therefore, we developed and pilot tested Adapt 2 Asthma (A2A), a family-based coping and asthma self-management intervention for low-SES Latinx families. METHODS: Children, parents, and primary care providers (N=16) participated in five focus groups to refine A2A’s content and delivery. Subsequently, families of children ages 9–12 with asthma (N=24) were recruited from primary care clinics and randomly assigned to receive A2A or enhanced usual care (EUC). RESULTS: Based on focus groups, A2A was refined to address feasibility, Latinx-specific cultural factors, and provider-family gaps. Results of the pilot RCT showed that 92% of families completed all sessions of A2A, and there were high levels of satisfaction with and fidelity to A2A. There were no statistically significant differences between the A2A and EUC groups at 3-month follow-up, although there were small, non-significant effects favoring A2A on parent-reported asthma control, parent secondary control coping, and emergency department visits. CONCLUSIONS: We found evidence of acceptability, feasibility, and potential benefits of A2A for low-SES Latinx families. Findings provide guidance for future implementation in primary care.

RATIONALE: Whether biomarkers can be used to predict response to inhaled corticosteroids (ICS) or long-acting muscarinic antagonists (LAMA) in mild persistent asthma is unclear. OBJECTIVES: In a prespecified exploratory analysis of a randomized clinical trial of 295 participants 12 years of age or older with uncontrolled mild persistent asthma, we sought to identify biomarkers of treatment response after 12 weeks of ICS (mometasone, 200 μg or 220 μg twice/d), LAMA (tiotropium, 5 μg/d), or placebo in adults (⩾18 yr) and adolescents (12–17 yr) separately. METHODS: The primary outcome was a composite outcome of asthma control (treatment failure, asthma control days, and forced expiratory volume in 1 second [FEV(1)]). Analyses examined type 2 inflammatory biomarkers and physiologic biomarkers. We assessed the area under the receiver operating characteristic curve (AUC) for response to ICS and LAMA (each versus placebo). An AUC of 0.5 suggests no discrimination, 0.7–0.8 is considered acceptable, more than 0.8–0.9 is considered excellent, and more than 0.9 is considered outstanding. RESULTS: In 237 adults, sputum and blood eosinophil levels and fractional exhaled nitric oxide (Fe(NO)) each predicted ICS response (AUCs: 0.61 [95% confidence interval (CI), 0.53–0.69], 0.64 [95% CI, 0.56–0.72], and 0.62 [95% CI, 0.54–0.70], respectively; all P

Children residing in low-income neighborhoods are disproportionately affected by asthma morbidity and mortality. Neighborhood violence has been explored in relationship to child morbidity and health and developmental outcomes, but less is known about the relationship of violence to caregiver mental health. The purpose of this study was to examine the relationship of neighborhood violent crime victimization (objective and subjective measures), perceptions of community well-being and support, and depressive symptoms among a sample of primarily single female caregivers of children with uncontrolled asthma. This is a secondary analysis of baseline data obtained from a randomized controlled trial of a home-based environmental control intervention for children aged 3 to 12 years, who were primarily African American, and diagnosed with persistent, uncontrolled asthma. Results showed that both objective and subjective measures of crime, particularly in those with relatively low life stress (P < .001), limited education of the caregiver (P < .001), and fewer children (P < .01) in the household had direct associations with depressive symptoms in caregivers of children with uncontrolled asthma. Neighborhood perceptions of satisfaction and a sense of community, as well as perceptions of social support, were not associated with depressive symptoms. Our findings emphasize the need to screen for depressive symptoms, life stress, as well as both objective and subjective perceptions of neighborhood violence among caregivers of children with poorly controlled asthma. Furthermore, when providing holistic care to these caregivers, stress reduction and the provision of mental health resources are paramount.

Introduction Allergic rhinitis is a form of IgE mediated inflammation of the nasal mucosa in response to specific allergens, resulting in typical symptoms. Objectives This study was designed with the primary goal of comparing the clinical efficacy of posterior nasal neurectomy with or without pharyngeal neurectomy for the treatment of moderate-to-severe perennial allergic rhinitis. Secondary study aims included a comparison of the severity of comorbidities, including chronic cough and asthma, between patients in these two surgical treatment groups. Methods A total of 52 patients were enrolled in this randomized controlled trial and were assigned to either the control group (posterior nasal neurectomy) or the experimental group (posterior nasal neurectomy + pharyngeal neurectomy). The visual analog scale and rhinoconjunctivitis quality of life questionnaire were used to compare the differences in patient symptoms between baseline and 6-, 12-, and 24-months post-treatment. In addition, patient cough and asthma symptoms were monitored during follow-up via visual analog scale and asthma control test respectively. Results No significant differences in preoperative scores were evident between groups (p> 0.05). At 6-months post-treatment, there were significant differences in visual analog scale, rhinoconjunctivitis quality of life questionnaire, and asthma control test scores relative to baseline values in experimental group and control group patients (p< 0.05), and this remained true upon 12- and 24-month follow-up. No significant differences in visual analog scale, rhinoconjunctivitis quality of life questionnaire, or asthma control test scores were observed between the two treatment groups at any postoperative follow-up time point (p> 0.05), while coughing severity was found to be significantly reduced in the experimental group relative to the control group (p< 0.05). Conclusion posterior nasal neurectomy can be safely implemented with or without pharyngeal neurectomy in order to effectively treat allergic rhinitis. Combined posterior nasal neurectomy and pharyngeal neurectomy treatment may offer greater value than posterior nasal neurectomy alone for the treatment of allergic rhinitis patients with chronic cough. Resumo Introdução A rinite alérgica é uma forma de inflamação da mucosa nasal mediada por IgE em resposta a alérgenos específicos, resulta em sintomas típicos. Objetivos Comparar a eficácia clínica da neurectomia nasal posterior com ou sem neurectomia faríngea para o tratamento da rinite alérgica perene de moderada a grave. Além disso, comparar a gravidade das comorbidades, inclusive tosse crônica e asma, entre os pacientes nesses dois grupos de tratamento cirúrgico. Método Foram incluidos neste ensaio clínico randomizado e designados para o grupo controle (neurectomia nasal posterior) ou para o grupo experimental (neurectomia nasal posterior + neurectomia faríngea) 52 pacientes. A escala visual analógica e o questionário de qualidade de vida na rinoconjuntivite (rhinoconjunctivitis quality of life questionnaire) foram usados para comparar as diferenças nos sintomas dos pacientes entre o período inicial e 6, 12 e 24 meses após o tratamento. Além disso, a tosse e os sintomas de asma dos pacientes foram monitorados durante o acompanhamento por meio da escala visual analógica e do teste de controle da asma (asthma control test ), respectivamente. Resultados Nenhuma diferença significante nos escores pré‐operatórios foi evidenciada entre os grupos (p > 0,05). Aos seis meses pós‐tratamento, houve diferenças significantes nos escores da escala visual analógica, no questionário de qualidade de vida na rinoconjuntivite e no teste de controle de asma em relação aos valores basais dos pacientes no grupo experimental e no grupo controle (p < 0,05), o que permaneceu verdadeiro após 12 e 24 meses de acompanhamento. Não foram observadas diferenças significantes nos escores da escala visual analógica e nem no questionário de qualidade de vida para conjuntivite ou no teste de controle da asma entre os dois grupos de tratamento em qualquer momento do acompanhamento pós‐operatório (p > 0,05), enquanto a gravidade da tosse foi significantemente reduzida no grupo experimental em relação ao grupo controle (p < 0,05). Conclusão A neurectomia nasal posterior pôde ser feita com segurança com ou sem neurectomia faríngea para o tratamento eficaz da rinite alérgica. O tratamento combinado com neurectomia nasal posterior e neurectomia faríngea pode oferecer mais benefício do que a neurectomia nasal posterior isolada para o tratamento de pacientes com rinite alérgica e tosse crônica.

Background:. Despite the recommendation of inhaled corticosteroids (ICSs) plus long-acting beta 2-agonist (LABA) and leukotriene receptor antagonist (LTRA) or ICS/LTRA as stepwise approaches in asthmatic children, there is a lack of published systematic review comparing the efficacy and safety of the two therapies in children and adolescents aged 4 to 18 years. This study aimed to compare the safety and efficacy of salmeterol/fluticasone (SFC) vs. montelukast (MON), or combination of montelukast and fluticasone (MFC) in children and adolescents aged 4 to 18 years with bronchial asthma. Methods:. A systematic search was conducted in MEDLINE, EMBASE, the Cochrane Library, China BioMedical Literature Database, Chinese National Knowledge Infrastructure, VIP Database for Chinese Technical Periodical, and Wanfang for randomized controlled trials (RCTs) published from inception to May 24, 2021. Interventions are as follows: SFC vs. MON, or combination of MFC, with no limitation of dosage or duration. Primary and secondary outcome measures were as follows: the primary outcome of interest was the risk of asthma exacerbation. Secondary outcomes included risk of hospitalization, pulmonary function, asthma control level, quality of life, and adverse events (AEs). A random-effects (I2 ≥ 50%) or fixed-effects model (I2

Background: The fractional exhaled nitric oxide (FENO) test is a point-of-care test that is used in the assessment of asthma.Objective: To provide evidence-based clinical guidance on whether FENO testing is indicated to optimize asthma treatment in patients with asthma in whom treatment is being considered.Methods: An international, multidisciplinary panel of experts was convened to form a consensus document regarding a single question relevant to the use of FENO. The question was selected from three potential questions based on the greatest perceived impact on clinical practice and the unmet need for evidencebased answers related to this question. The panel performed systematic reviews of published randomized controlled trials between 2004 and 2019 and followed the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) evidence-to-decision framework to develop recommendations. All panel members evaluated and approved the recommendations.Main Results: After considering the overall low quality of the evidence, the panel made a conditional recommendation for FENO-based care. In patients with asthma in whom treatment is being considered, we suggest that FENO is beneficial and should be used in addition to usual care. This judgment is based on a balance of effects that probably favors the intervention; the moderate costs and availability of resources, which probably favors the intervention; and the perceived acceptability and feasibility of the intervention in daily practice.Conclusions: Clinicians should consider this recommendation to measure FENO in patients with asthma in whom treatment is being considered based on current best available evidence.

Background and aims Asthma exacerbation is defined as an acute attack of shortness of breath with more than 25% decrease in morning peak flow compared to the baseline on 2 consecutive days, which requires immediate standard therapy. The majority of asthmatic patients are considered to be steroid-sensitive; however, corticosteroid-resistant asthma is a subset of asthma with poor response to corticosteroids and is responsible for frequent hospital admissions. In this study we aimed to compare the effects of two enhancing strategies, the nebulized ketamine and IV magnesium sulfate, in treatment of severe steroid resistant asthma. Materials and methods This double-blind randomized clinical trial was conducted on patients who presented to a referral clinic in Alborz, Iran. Using random allocation, patients were divided into two groups. The first group was treated with nebulized ketamine and the second group was treated with intravenous magnesium sulfate. Peak expiratory flow rates were assessed before the intervention, 30 and 60 min after the intervention and compared with the aid of SPSS software. Results The Peak expiratory flow rates before the intervention, 30 min and 60 min after the intervention was statistically significantly different in both ketamine and magnesium sulfate groups. Peak expiratory flow rates change between 0 and 60 min were 29.4 and 15.2% in the ketamine and magnesium sulfate group respectively. Although the ketamine group showed much higher increase in mean PEFR compared to the MgSO4 groups, there was no statistically significant difference across both groups. Conclusion Our study concluded that combined with standard therapy, both ketamine and IV magnesium sulfate are effective agents in the improvement of PEFR in patients with acute severe asthma that failed to respond to traditional therapies. However, there were no statistically significant difference between the two groups.

The management of medication nonadherence of patients with asthma or chronic obstructive pulmonary disease (COPD) remains challenging. Given the multitude of underlying causes, a personalized approach is required. The Test of Adherence to Inhalers (TAI) can identify reasons for nonadherence, but it does not provide guidance regarding how to act effectively after results.To develop a practical, evidence-based decision support toolkit for health care professionals managing adult patients with asthma and/or COPD, by matching TAI-identified adherence barriers to proven effective adherence-enhancing interventions.We performed a literature review in PubMed and Embase identifying interventions that enhanced medication adherence in adult patients with asthma and/or COPD. Randomized controlled trials published in English with full texts available were included. Effective interventions assessed by the Cochrane risk of bias tool were categorized, matched with specific TAI responses, and developed into a practical TAI Toolkit. The Toolkit was assessed for content and usability (System Usability Scale) by a multidisciplinary group of health care professionals.In total, 40 randomized controlled trials were included in the review. Seven effective interventions categories were identified, informing the TAI Toolkit: reminders, educational interventions, motivational strategies, feedback on medication use, shared decision-making, simplifying the medication regimen, and multiple component interventions. Health care professionals rated the TAI Toolkit with a mean System Usability Scale score of 71.4 (range, 57.5-80.0).Adherence can be improved using the different interventions that the TAI Toolkit helps select. The TAI Toolkit was well-received by health care professionals. Further research is required to test its validity, practicality, and effectiveness in practice.

Mohammed A Almeshari,1,2 Nowaf Y Alobaidi,1,3 Elizabeth Sapey,1,4 Omar Usmani,5 Robert A Stockley,6 James A Stockley7 1Birmingham Acute Care Research Group, Institute of Inflammation and Ageing, University of Birmingham, Birmingham, B15 2TT, UK; 2Rehabilitation Health Sciences Department, College of Applied Medical Sciences, King Saud University, Riyadh, Saudi Arabia; 3Respiratory Therapy Department, King Saud Bin Abdulaziz University for Health Sciences, Alahsa, Saudi Arabia; 4Acute Medicine, University Hospitals Birmingham NHS Foundation Trust, Birmingham, B15 2GW, UK; 5Imperial College of London, London, UK; 6Department of Respiratory Medicine, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK; 7Lung Function & Sleep Department, Respiratory Medicine, University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital Birmingham, Birmingham, UKCorrespondence: Mohammed A AlmeshariRehabilitation Health Science Department, College of Applied Medical Sciences, King Saud University, P. Box 145111,, Riyadh, ZIP 4545, Saudi ArabiaTel +966 50 8033 880Email malmeshari@ksu.edu.saBackground: Bronchodilator responsiveness (BDR) is commonly used in the diagnosis of lung disease. Although small airways dysfunction is a feature of asthma and COPD, physiological tests of small airways are not included in guidelines for BDR testing. This systematic review assessed the current evidence of BDR using small airways function in asthma and COPD.Methods: The systematic review used standard methodology with the protocol prospectively registered on PROSPERO (CRD42020164140). Electronic medical databases (EMBASE and Medline) were searched using related keywords. Abstracts and full texts were screened independently by two reviewers. Studies that reported the change of physiological small airways function and FEV1 were included in the review. The revised Cochrane risk of bias tool for RCT and NIH quality assessment tool for cohort and cross-sectional studies were used to evaluate the studies.Results: A total of 934 articles were identified, with 12 meeting the inclusion criteria. Ten studies included asthma patients, 1 study included COPD patients and 1 study included both asthma and COPD. A total of 1104 participants were included, of whom 941 were asthmatic, 64 had COPD and 109 were healthy controls. Studies were heterogeneous in design including the device, dose and time intervals for BDR assessment. A small airway BDR was seen for most tests in asthma and COPD, including oscillometry (R5-20, reactance (X5), area of reactance (AX) and resonant frequency (Fres)) and Maximal Mid Expiratory Flow.Conclusion: There is a measurable BDR in the small airways. However, with no consensus on how to assess BDR, studies were heterogeneous. Further research is needed to inform how BDR should be assessed, its clinical impact and place in routine clinical practice.Keywords: asthma, COPD, bronchodilator, reversibility, small airways function

Objective(s) This study explored the feasibility, acceptability, preliminary impact, and functionality of two risk reduction mobile application (app) interventions on asthma outcomes as compared to a control arm during wildfire season. Design Three-arm, 8-week randomized clinical trial. Sample Sixty-seven young adults with asthma were enrolled. Measurements The Asthma Control Test, forced expiratory volume in one second (FEV1 ) and the System Usability Scale were measured at baseline, 4, and 8 weeks. The Research Attitude Scale was administered at 8 weeks. Twenty participants from the two intervention arms completed an optional survey and six were interviewed after completing the study. Intervention Both intervention arms could access Smoke Sense Urbanova, an app that supports reducing risks from breathing wildfire smoke. The Smoke Sense Urbanova Plus arm also monitored their daily FEV1 , received air quality notifications, and accessed preventive tips and a message board. Results Most participants agreed the app and spirometer were usable and their privacy and confidentiality were maintained. No adverse events were reported. Conclusions Participant-identified recommendations will support intervention refinement and testing. This research supports asthma self-management tools that public health nurses and community health workers can recommend for at-risk populations.

Background Currently there is no systematic review and meta-analysis of the global incidence rates of anaphylactic and nonanaphylactic reactions to SARS-CoV-2 vaccines in the general adult population. Objectives To estimate the incidence rates of anaphylactic and nonanaphylactic reactions after COVID-19 vaccines and describe the demographic and clinical characteristics, triggers, presenting signs and symptoms, treatment and clinical course of confirmed cases. Design A systematic review and meta-analysis. Preferred Reporting Items for Systematic Reviews and Meta-Analyses [PRISMA] statement was followed. Methods Electronic databases (Proquest, Medline, Embase, Pubmed, CINAHL, Wiley online library, and Nature) were searched from 1 December 2020 to 31 May 2021 in the English language using the following keywords alone or in combination: anaphylaxis, non-anaphylaxis, anaphylactic reaction, nonanaphylactic reaction, anaphylactic/anaphylactoid shock, hypersensitivity, allergy reaction, allergic reaction, immunology reaction, immunologic reaction, angioedema, loss of consciousness, generalized erythema, urticaria, urticarial rash, cyanosis, grunting, stridor, tachypnoea, wheezing, tachycardia, abdominal pain, diarrhea, nausea, vomiting and tryptase. We included studies in adults of all ages in all healthcare settings. Effect sizes of prevalence were pooled with 95% confidence intervals (CIs). To minimize heterogeneity, we performed sub-group analyses. Results Of the 1,734 papers that were identified, 26 articles were included in the systematic review (8 case report, 5 cohort, 4 case series, 2 randomized controlled trial and 1 randomized cross-sectional studies) and 14 articles (1 cohort, 2 case series, 1 randomized controlled trial and 1 randomized cross-sectional studies) were included in meta-analysis. Studies involving 26,337,421 vaccine recipients [Pfizer-BioNTech (n = 14,505,399) and Moderna (n = 11,831,488)] were analyzed. The overall pooled prevalence estimate of anaphylaxis to both vaccines was 5.0 (95% CI 2.9 to 7.2, I2 = 81%, p = I2 = 99%, p = I2 = 85% versus 2.8, 95% CI 0.0 to 5.7, I2 = 59%). However, lower incidence of nonanaphylactic reactions was associated with Pfizer-BioNTech compared to Moderna (43.9, 95% CI 0.0 to 131.9, I2 = 99% versus 63.8, 95% CI 0.0 to 151.8, I2 = 98%). The funnel plots for possible publication bias for the pooled effect sizes to determine the incidence of anaphylaxis and nonanaphylactic reactions associated with mRNA COVID-19 immunization based on mRNA vaccine type appeared asymmetrical on visual inspection, and Egger’s tests confirmed asymmetry by producing p values Conclusion The prevalence of COVID-19 mRNA vaccine-associated anaphylaxis is very low; and nonanaphylactic reactions occur at higher rate, however, cutaneous reactions are largely self-limited. Both anaphylactic and nonanaphylactic reactions should not discourage vaccination.

Background: Bronchial asthma (BA) is a chronic airway inflammatory disease with reversible airflow limitation as the main clinical manifestations, such as wheezing, cough, shortness of breath, chest tightness, etc., mediated by a variety of inflammatory cells, which can be recurrent. Clinical can improve symptoms, but can not be cured, glucocorticoid is the most important first-line medication. Clinical practice has shown that montelukast sodium combined with fluticasone in the treatment of adult bronchial asthma can improve clinical efficacy and reduce adverse reactions. The purpose of this study is to systematically study the efficacy and safety of montelukast sodium combined with fluticasone in the treatment of adult bronchial asthma. Methods: The Chinese databases (CNKI, VIP, Wanfang, Chinese Biomedical Database) and English databases (PubMed, the Cochrane Library, Embase, Web of Science) were searched by computer, for the randomized controlled clinical studies of montelukast sodium combined with fluticasone in the treatment of adult bronchial asthma from establishment of database to October 2020. Two researchers independently extracted the relevant data and evaluated the quality of the literatures, and used RevMan5.3 software to conduct meta-analyze of the included literatures. Results: This study assessed the efficacy and safety of montelukast sodium combined with fluticasone in the treatment of adult bronchial asthma through total effective rate, pulmonary function (FEV1, FVC, PEF, FEV1/FVC), and adverse reactions. Conclusion: this study will provide reliable evidence-based evidence for the clinical application of montelukast sodium combined with fluticasone in the treatment of adult bronchial asthma.

OBJECTIVE: Mepolizumab proved to be an efficacious treatment for eosinophilic granulomatosis with polyangiitis (EGPA) at a dose of 300 mg every 4 weeks in the randomized, controlled MIRRA trial. In a few recently reported studies, successful real-life experiences with the approved dose for treating severe eosinophilic asthma (100 mg every 4 weeks) were observed. We undertook this study to assess the effectiveness and safety of mepolizumab 100 mg every 4 weeks and 300 mg every 4 weeks in a large European EGPA cohort. METHODS: We included all patients with EGPA treated with mepolizumab at the recruiting centers in 2015-2020. Treatment response was evaluated from 3 months to 24 months after initiation of mepolizumab. Complete response to treatment was defined as no disease activity (Birmingham Vasculitis Activity Score [BVAS] = 0) and a prednisolone or prednisone dose (or equivalent) of ���4 mg/day. Respiratory outcomes included asthma and ear, nose, and throat (ENT) exacerbations. RESULTS: Two hundred three patients, of whom 191 received a stable dose of mepolizumab (158 received 100 mg every 4 weeks and 33 received 300 mg every 4 weeks) were included. Twenty-five patients (12.3%) had a complete response to treatment at 3 months. Complete response rates increased to 30.4% and 35.7% at 12 months and 24 months, respectively, and rates were comparable between mepolizumab 100 mg every 4 weeks and 300 mg every 4 weeks. Mepolizumab led to a significant reduction in BVAS score, prednisone dose, and eosinophil counts from 3 months to 24 months, with no significant differences observed between 100 mg every 4 weeks and 300 mg every 4 weeks. Eighty-two patients (40.4%) experienced asthma exacerbations (57 of 158 [36%] who received 100 mg every 4 weeks; 17 of 33 [52%] who received 300 mg every 4 weeks), and 31 patients (15.3%) experienced ENT exacerbations. Forty-four patients (21.7%) experienced adverse events (AEs), most of which were nonserious AEs (38 of 44). CONCLUSION: Mepolizumab at both 100 mg every 4 weeks and 300 mg every 4 weeks is effective for the treatment of EGPA. The 2 doses should be compared in the setting of a controlled trial.

Background Currently, five biologic treatment options are available for use in patients with uncontrolled persistent asthma: three interleukin (IL)-5 antagonists, which either bind to the anti-IL-5 ligand (mepolizumab, reslizumab) or to the IL-5 receptor (benralizumab); one anti-immunoglobulin E (anti-IgE) therapy (omalizumab); and one anti-IL-4/IL-13 therapy (dupilumab). To date, no comparative data from head-to-head clinical trials are available for these biologics. Objective An indirect treatment comparison (ITC) of dupilumab versus each of the anti-IL-5 and anti-IgE therapies using the endpoints of annualized severe asthma exacerbation rates and change in pre-bronchodilator forced expiratory volume in 1 s (FEV1). Methods Embase®, MEDLINE®, and Cochrane Central Register of Controlled Trials (CENTRAL) were searched for studies published between January 1, 1980 and March 25, 2019. Eligible articles included randomized controlled trials (RCTs) in patients aged ≥ 12 years with persistent/uncontrolled asthma using at least medium-to-high dose inhaled corticosteroid plus long-acting β2-agonist with add-on biologic therapy. Bucher ITCs were performed to compare subgroups of dupilumab patients with the anti-IL-5s and anti-IgE trial populations. Results Fourteen RCTs were included in the analyses. The matched dupilumab subgroups were associated with greater reductions in annualized severe exacerbation rates compared with benralizumab, mepolizumab, reslizumab, and omalizumab (54%, 28%, 38%, and 26% greater reduction, respectively). A greater improvement in FEV1 was also observed for dupilumab at week 12 and/or week 24/52 than for the other biologics (0.06–0.14 L). Conclusion In this ITC, dupilumab was associated with lower severe asthma exacerbation rates and greater improvements in lung function than anti-IL-5s and omalizumab.

Background Data on pediatric asthma morbidity and effective environmental interventions in U.S. agricultural settings are few. We evaluated the effectiveness of HEPA air cleaners on asthma morbidity among a cohort of rural Latino children. Methods Seventy-five children with poorly controlled asthma and living in non-smoking homes were randomly assigned to asthma education alone or along with HEPA air cleaners placed in their sleeping area and home living room. The Asthma Control Test (ACT) score, asthma symptoms in prior 2 weeks, unplanned clinical utilization, creatinine-adjusted urinary leukotriene E4 (uLTE4 [ng/mg]), and additional secondary outcomes were evaluated at baseline, six, and 12 months. Group differences were assessed using multivariable-adjusted generalized estimating equations. Incident rate ratios of ever experiencing the metrics of poorer asthma health during follow-up (suboptimal asthma management) were estimated using Poisson regression models in secondary analysis. Results Mean child age was 9.2 and 8.6 years in intervention and control groups, respectively, and two-thirds of participants were male. Primary analysis of repeated measures of ACT score did not differ between groups (HEPA group mean change compared to controls 10% [95% CI: − 12-39%]). A suggestion of greater decrease in uLTE4 (ng/mg creatinine) was observed (− 10% [95% CI: − 20 -1%]). Secondary analysis showed children with HEPAs were less likely to have an ACT score meeting a clinically defined cutoff for poorly controlled asthma using repeated measures (IRR: 0.45 [95% CI: 0.21–0.97]). In Poisson models, intervention participants had reduced risk of ever meeting this cutoff (IRR: 0.43 [95% CI: 0.21–0.89]), ever having symptoms in the past 2 weeks (IRR: 0.71 [95% CI: 0.52–0.98]), and lower risk of any unplanned clinical utilization (IRR: 0.35 [95% CI: 0.13–0.94]) compared to control participants. Discussion The HAPI study showed generally improved outcomes among children in the HEPA air cleaner group. However, primary analyses did not meet statistical significance and many outcomes were subjective (self-report) in this unblinded study, so findings must be interpreted cautiously. HEPA air cleaners may provide additional benefit for child asthma health where traditional asthmagens (traffic, tobacco smoke) are not prominent factors, but larger studies with more statistical power and blinded designs are needed. Trial registration ClinicalTrials.gov Identifier: NCT04919915. Date of retrospective registration: May 19, 2021.

BackgroundInterferential therapy (IFT) is the application of two medium frequency currents to the skin to stimulate and activate different systems in the body using specific frequencies and frequency ranges. IFT aims to reduce myalgia in the chest and upper back, reduce muscular fatigue and induce mucus expectoration. This study is designed to compare the efficacy of IFT on asthma control and quality of life of asthma patients pre-and post-administration of bronchodilators and determine the most influential body position in its application.MethodsForty-eight (48) patients aged 18 years and above with bronchial Asthma attending the respiratory clinic at the Lagos State University Teaching Hospital, Ikeja (LASUTH) will be assessed for the study eligibility. The study design will be a double-blinded, randomized control trial with four intervention groups and four parallel placebo control groups. IFT will be administered as an intervention to patients on short and long-acting bronchodilators in an assigned fundamental body position for 20 minutes. Six continuous outcome variables at different points will be utilized as an outcome measure. Baseline Pulmonary Function Test (PFT) will be assessed on entry into the study, Quality of life and asthma control will be evaluated every two (2) weeks of the study. Data obtained will be analyzed using descriptive and inferential statistics of repeated ANOVA; PDiscussionThe study outcome will compare the efficacy of IFT on Bronchial Asthma, identify its effect in different body positions, and compare the relationship between its application and the bronchodilator medication frequently used by the patients.Trial Registrationhttps://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=10942:PACTR202005807526130

Background Asthma and/or airway hyper-responsiveness (AHR) are common in elite endurance athletes with a high prevalence rate of beta-2 adrenoreceptor (beta-2) agonists use. Nevertheless, there are data on dose-dependent ergogenic effects of beta-2 agonists suggesting increased muscle strength, endurance and neuromuscular performance. Therefore, most beta-2 agonists belong to the World Anti Doping Agency (WADA) list of prohibited substances and it is tempting to speculate that illegitimate use of beta-2 agonists might be a common practice to boost performance in competitive sports. It is currently unknown whether or not inhaled beta-2 agonists enhance performance by stimulatory effects in skeletal and cardiac muscle. Methods The ELSA trial is a double-blinded, placebo-controlled, randomized, balanced, four-way cross-over study. Study participants (n=24, 12 ♀, 12 ♂) complete four study arms (i.e. periods with treatment A, placebo; B, salbutamol; C, formoterol; D, formoterol + salbutamol) in random order after an initial preliminary testing session. Participants inhale the study medication 20 min before the 10-min time trial (TT; exercise performance test), where participants cycle 10 min at the highest possible workload. Cardiac output is measured continuously. A skeletal muscle biopsy is collected 3 h after the TT. Study endpoints include measures of skeletal muscle expression of nuclear receptors, hormones and cytokine levels, urinary and plasma concentrations of salbutamol and formoterol, circulating cardiac markers, cardiopulmonary function and exercise performance (average power and peak power during the TT). Blood and urine are collected and respiratory testing is performed 24 h post TT. Summary/conclusions This clinical trial evaluates the potential performance-enhancing effects of non-prohibited, not medically indicated inhaled short- and long-acting beta-2 agonists on skeletal muscle gene expression, endocrine regulation, cardiac biomarkers, cardiopulmonary function and acute endurance exercise performance. These data will be used by WADA to adapt the annually published list of prohibited substances (WADA 2021) and will be published in scientific journals. Trial registration The trial is registered at the European Clinical Trials Database (Eudra CT) with the number: 2015-005598-19 as well as at the German register for clinical studies (DRKS number 00010574).

Background Asthma is a chronic disease in which inflammation of the airways causes symptomatic wheezing, coughing and difficult breathing. Macrolides are antibiotics with antimicrobial and anti-inflammatory activities that have been explored for the long-term control of asthma symptoms. Objectives To assess the effects of macrolides compared with placebo for managing chronic asthma. Search methods We searched the Cochrane Airways Group Specialised Register up to March 2021. We also manually searched bibliographies of previously published reviews and conference proceedings and contacted study authors. We included records published in any language in the search. Selection criteria We included randomised controlled clinical trials (RCTs) involving both children and adults with asthma treated with macrolides versus placebo for four or more weeks. Primary outcomes were exacerbation requiring hospitalisation, severe exacerbations (exacerbations requiring emergency department (ED) visits or systemic steroids, or both), symptom scales, asthma control questionnaire (ACQ, score from 0 totally controlled, to 6 severely uncontrolled), Asthma Quality of Life Questionnaire (AQLQ, with score from 1 to 7 with higher scores indicating better QoL), rescue medication puffs per day, morning and evening peak expiratory flow (PEF; litres per minutes), forced expiratory volume in one second (FEV1; litres), bronchial hyperresponsiveness, and oral corticosteroid dose. Secondary outcomes were adverse events (including mortality), withdrawal, blood eosinophils, sputum eosinophils, eosinophil cationic protein (ECP) in serum, and ECP in sputum. Data collection and analysis Two review authors independently examined all records identified in the searches then reviewed the full text of all potentially relevant articles before extracting data in duplicate from all included studies. As per protocol, we used a fixed-effect model. We conducted a sensitivity analysis for analyses with high heterogeneity (I2 greater than 30%). GRADE was used to assess the certainty of the body of evidence. Main results Twenty-five studies met the inclusion criteria, randomising 1973 participants to receive macrolide or placebo for at least four weeks. Most of the included studies reported data from adults (mean age 21 to 61 years) with persistent or severe asthma, while four studies included children. All participants were recruited in outpatient settings. Inclusion criteria, interventions and outcomes were highly variable. The evidence suggests macrolides probably deliver a moderately sized reduction in exacerbations requiring hospitalisations compared to placebo (odds ratio (OR) 0.47, 95% confidence interval (CI) 0.20 to 1.12; studies = 2, participants = 529; moderate-certainty evidence). Macrolides probably reduce exacerbations requiring ED visits and/or treatment with systemic steroids (rate ratio (RaR) 0.65, 95% CI 0.53 to 0.80; studies = 4, participants = 640; moderate-certainty evidence). Macrolides may reduce symptoms (as measured on symptom scales) (standardised mean difference (SMD) -0.46, 95% CI -0.81 to -0.11; studies = 4, participants = 136 ; very low-certainty evidence). Macrolides may result in a little improvement in ACQ (SMD -0.17, 95% CI -0.31 to -0.03; studies = 5, participants = 773; low-certainty evidence). Macrolides may have little to no effect on AQLQ (mean difference (MD) 0.24, 95% CI 0.12 to 0.35; studies = 6, participants = 802; very low-certainty evidence). For both the ACQ and the AQLQ the suggested effect of macrolides versus placebo did not reach a minimal clinically important difference (MCID, 0.5 for ACQ and AQLQ) (ACQ: low-certainty evidence; AQLQ: very low-certainty evidence). Due to high heterogeneity (I2 > 30%), we conducted sensitivity analyses on the above results, which reduced the size of the suggested effects by reducing the weighting on the large, high quality studies. Macrolides may result in a small effect compared to placebo in reducing need for rescue medication (MD -0.43 puffs/day, 95% CI -0.81 to -0.04; studies = 4, participants = 314; low-certainty evidence). Macrolides may increase FEV1, but the effect is almost certainly below a level discernible to patients (MD 0.04 L, 95% CI 0 to 0.08; studies = 10, participants = 1046; low-certainty evidence). It was not possible to pool outcomes for non-specific bronchial hyperresponsiveness or lowest tolerated oral corticosteroid dose (in people requiring oral corticosteroids at baseline). There was no evidence of a difference in severe adverse events (including mortality), although less than half of the studies reported the outcome (OR 0.80, 95% CI 0.49 to 1.31; studies = 8, participants = 854; low-certainty evidence). Reporting of specific adverse effects was too inconsistent across studies for a meaningful analysis. Authors' conclusions Existing evidence suggests an effect of macrolides compared with placebo on the rate of exacerbations requiring hospitalisation. Macrolides probably reduce severe exacerbations (requiring ED visit and/or treatment with systemic steroids) and may reduce symptoms. However, we cannot rule out the possibility of other benefits or harms because the evidence is of very low quality due to heterogeneity among patients and interventions, imprecision and reporting biases. The results were mostly driven by a well-designed, well powered RCT, indicating that azithromycin may reduce exacerbation rate and improve symptom scores in severe asthma. The review highlights the need for researchers to report outcomes accurately and according to standard definitions. Macrolides can reduce exacerbation rate in people with severe asthma. Future trials could evaluate if this effect is sustained across all the severe asthma phenotypes, the comparison with newer biological drugs, whether effects persist or wane after treatment cessation and whether effects are associated with infection biomarkers.

To effectively support asthma self-management among children most at risk for poor outcomes, it is important to examine potential disparities in parents' asthma-related knowledge. This study draws on baseline data collected from a randomized controlled trial to analyze how knowledge of asthma self-management varies by sociodemographic characteristics in a racially and economically diverse sample of Medicaid-insured children seeking emergency asthma care (N=221). Multivariable linear regression revealed that parent race/ethnicity, preferred language, and education were independently associated with scores on the Asthma Self Management Knowledge Questionnaire, and there was a significant interaction between parent race/ethnicity and education. In analyses stratified by parent education level, Latinx race/ethnicity was associated with lower-self-management knowledge among parents with higher education level, but not among those with a lower level of education. Our findings call for further research to understand and address the unique barriers to improving asthma self-management knowledge among Latinx parents and parents with limited English proficiency.

BackgroundRespiratory impairments are adjusted reduction in pulmonary function that manifests with adverse effects on an individual’s state of health. The basis for identifying these impairments requires differentiation between normal and abnormal ventilatory capacity to avoid inaccurate and potentially harmful drug prescriptions and a mismatch of diagnoses. Incentive Spirometry (IS) is a technique designed to help patients achieve a pre-set volume of airflow; the volume is determined from predicted values or baseline measurements.MethodsFifty-four (54) patients with Obstructive, Restrictive, or Mixed type of respiratory impairments attending the respiratory clinic of Lagos State University Teaching Hospital, Ikeja (LASUTH) will be assessed for eligibility for the study. The study design will be a double-blind, randomized control trial with six intervention groups and three placebo control groups.The study’s independent variable will be an Inspiratory Incentive Spirometry (IIS) and Expiratory Incentive Spirometry (EIS), while Obstructive, Restrictive, and Mixed respiratory impairments will serve as the dependent variable for the study. Baseline Pulmonary Function Test (PFT) will be assessed on entry into the study, and after every procedure, six minutes’ walk (6MWT) test and CAT assessment test will be assessed at every two (2) weeks interval of the study. Data will be analyzed using descriptive and inferential statistics of repeated ANOVA; PDiscussionThe study outcome will determine the relationship between inspiratory and expiratory incentive spirometry on respiratory impairments and deduce the best fit device for the respective impairment.Trial Registrationwww.pactr.org: PACTR202005904039357

BACKGROUND Management of preschool wheeze is based predominantly on symptom patterns. OBJECTIVE To determine whether personalizing therapy using blood eosinophils or airway bacterial infection results in fewer attacks compared with standard care. METHODS A proof-of-concept, randomized trial to investigate whether the prescription of inhaled corticosteroids (ICS) guided by blood eosinophils, or targeted antibiotics for airway bacterial infection, results in fewer unscheduled healthcare visits (UHCVs) compared with standard care. Children aged 1-5 years with ≥2 wheeze attacks in the previous year were categorized as episodic viral wheeze (EVW) or multiple trigger wheeze (MTW). The intervention group was prescribed ICS if blood eosinophils ≥3%, or targeted antibiotics if there is positive culture on induced sputum/cough swab. The control group received standard care. The primary outcome was UHCV at 4 months. RESULTS 60 children, with a median age of 36.5 (range 14-61) months, were randomized. Median blood eosinophils were 5.2 (range 0-21)%, 27 of 60 (45%) children were atopic, and 8 of 60 (13%) had airway bacterial infection. There was no relationship between EVW, MTW and either blood eosinophils, atopic status or infection. 67% in each group were prescribed ICS. 15 of 30 control subjects and 16 of 30 patients in the intervention group had UHCV over 4 months (p = .8). The time to first UHCV was similar. 50% returned adherence monitors; in those, median ICS adherence was 67%. There were no differences in any parameter between those who did and did not have an UHCV. CONCLUSION Clinical phenotype was unrelated to allergen sensitization or blood eosinophils. ICS treatment determined by blood eosinophils did not impact UHCV, but ICS adherence was poor.

RVA Breathes, a community program to improve asthma management and care coordination among children living in a low-income, urban area, is being evaluated in a randomized clinical trial. In March 2020, RVA Breathes was converted to a remote program due to the COVID-19 pandemic; this report provides an update on the modifications made to the RVA Breathes trial. Additionally, given that families in the program have been disproportionally impacted by both COVID-19 and significant social unrest at both the local and national level, strategies used to enroll and engage families in the trial who bore disproportionately high burdens during this time period are outlined. Remote sessions (telephone or video) for families enrolled in the program prior to the onset of COVID-19 began in April 2020; enrollment of new families began remotely in July 2020 using adapted consent procedures. Baseline, intervention, and follow-up sessions were delivered either via the telephone or video depending upon family preference. Strategies were implemented to engage caregivers and children in completing measures over the telephone or video versus in person. Tangible intervention materials and participant payments were dropped off at family homes using contactless procedures. Our team was able to adapt and safely continue a large, community-based clinical trial, despite the increased health risks and social isolation mandates from the pandemic, by transitioning to a remote format. Challenges remain in determining whether RVA Breathes as a remote program has had the same impact on child asthma as the face-to-face interventions that comprised its original format.

We conducted a scoping review of studies on health outcomes from electronic nicotine delivery systems (ENDS). The objective was to identify, narratively synthesize, assess the strength and quality of evidence and critically appraise studies that have reported disease end points associated with the use of ENDS. We included published literature on the health impact of ENDS from 01/01/2015 until 01/02/2020 following the PRISMA guidelines using PubMed, Embase, Scopus and Google Scholar. The database search identified 755 studies, and other sources 265; 37 studies met final eligibility criteria. Levels of evidence included 24(65%) cross-sectional, one (2.7%) case–control and six (16%) case studies, four (11%) cohort studies, one (2.7%) randomized controlled trial (RCT) and one (2.7%) meta-analysis; 27(73%) studies reported only on harms, eight (22%) reported on benefits, two (2%) on benefits and harms. Quality ratings were poor in 20 (54%), fair in 9(24%) and good in 8(22%) of studies. In our review, ENDS was not shown to be causative for harmful cardiovascular disease (CVD) outcomes and shown to be beneficial for hypertensive patients. Switching from cigarettes to e-cigarettes resulted in reduced exacerbations of chronic obstructive pulmonary disease (COPD), with no evidence of long-term deterioration in lung function. Mental Health, cancer and mortality were not adequately studied to form any consensus. Our review has not demonstrated ENDS to be causative of harmful CVD outcomes; furthermore switching from cigarettes to e-cigarettes was associated with improved hypertensive control and reduced exacerbations of COPD, with no evidence of increased asthma risk or long-term respiratory harm. Mental health, cancer and mortality outcomes have not been adequately studied to form a conclusion. Overall, the findings of our review did not provide evidence to counter the consensus held by many that ENDS use is safer than the risks posed from smoking cigarettes.

Objective:\ud \ud To conduct an umbrella review collating the existing evidence to determine whether there is an association between exposure of Paracetamol in-utero or in infancy and the development of childhood Asthma.\ud \ud Methods:\ud \ud In this review, systematic reviews with or without meta-analysis that reported the association between paracetamol and asthma in children were included. To identify relevant reviews, a search was performed in the electronic databases PubMed, the Cochrane Library, and Ovid MEDLINE. The protocol was registered in PROSPERO CRD42020156023. A separate search was conducted for primary studies from the last 5 years not yet included in systematic reviews reporting the association from January 2016 to March 2021.\ud \ud Results:\ud \ud The electronic searches identified 1966 review titles. After the removal of 493 duplicates, 1475 titles and abstracts were screened against the eligibility criteria. Full-text screening yielded six systematic reviews to be included in this review. The search for primary studies in the last 5 years yielded 1214 hits, out of which 5 studies were found suitable for inclusion. Three of them, that were not included in the systematic reviews, and have been summarised in this paper. The odds ratios (ORs) for the outcome of asthma in offspring of mothers with prenatal paracetamol consumption in any trimester were 1.28 (1.13–1.39) and 1.21 (1.02–1.44). For first trimester exposures, they were 1.12 (0.99–1.27), 1.39 (1.01–1.91), and 1.21 (1.14–1.28), for the second or third trimester, they were 1.49 (1.37–1.63) and 1.13 (1.04–1.23). For the third trimester only, the figure was 1.17 (1.04–1.31). Of the six reviews included, 1 had a low risk of bias, 2 had an unclear risk while 3 had a high risk of bias assessed using the ROBIS tool. There was no significant increased risk of asthma with early infancy exposure. The inter-study heterogeneity varied from I2 = 41% to I2 = 76% across reviews. In the primary studies, the OR for prenatal exposure ranged from 1.12 (0.25–4.98) to 4.66 (1.92–11.3) and for infancy exposure was 1.56 (1.06–2.30). All three included primary studies were adjudged to be of high quality using the Newcastle Ottawa scale.\ud \ud Conclusions:\ud \ud There is a modest association between paracetamol exposure in-utero and the future development of asthma. Exposure in infancy has a less consistant association. All the studies done thus far are observational in nature, with their inherent biases. Further research, preferably randomized controlled trials are recommended to answer this pertinent question.

Background Asthma is the most common chronic disease in children, many of whom are managed solely with a short-acting β2-agonist (SABA). In adults, the evidence that budesonide-formoterol as sole reliever therapy markedly reduces the risk of severe exacerbations compared with SABA alone has contributed to the Global Initiative for Asthma recommending against SABA monotherapy in this population. The current lack of evidence in children means it is unknown whether these findings are also relevant to this demographic. High-quality randomised controlled trials (RCTs) are needed. Objective The aim of this study is to determine the efficacy and safety of as-needed budesonide-formoterol therapy compared with as-needed salbutamol in children aged 5 to 15 years with mild asthma, who only use a SABA. Methods A 52-week, open-label, parallel group, phase III RCT will recruit 380 children aged 5 to 15 years with mild asthma. Participants will be randomised 1:1 to either budesonide-formoterol (Symbicort Rapihaler®) 50/3 µg, two actuations as needed, or salbutamol (Ventolin®) 100 µg, two actuations as needed. The primary outcome is asthma attacks as rate per participant per year. Secondary outcomes assess asthma control, lung function, exhaled nitric oxide and treatment step change. A cost-effectiveness analysis is also planned. Conclusion This is the first RCT to assess the safety and efficacy of as-needed budesonide-formoterol in children with mild asthma. The results will provide a much-needed evidence base for the treatment of mild asthma in children., This protocol describes the first randomised controlled trial to investigate the efficacy and safety of budesonide/formoterol as sole reliever therapy for children with mild asthma, providing urgently needed evidence in this population https://bit.ly/35v0R3Z

ObjectiveTo test the feasibility and acceptability of a short-term reminder and incentives intervention in adolescents with low adherence to asthma medications.MethodsMixed-methods feasibility study in a tertiary care clinic. Adolescents recruited to a 24-week programme with three 8-weekly visits, receiving electronic reminders to prompt inhaled corticosteroid (ICS) inhalation through a mobile app coupled with electronic monitoring devices (EMD). From the second visit, monetary incentives based on adherence of ICS inhalation: £1 per dose, maximum £2 /day, up to £112/study, collected as gift cards at the third visit. End of study interviews and questionnaires assessing perceptions of asthma and ICS, analysed using the Perceptions and Practicalities Framework.ParticipantsAdolescents (11–18 years) with documented low ICS adherence (Results10 out of 12 adolescents approached were recruited (7 males, 3 females, 12–16 years). Eight participants provided adherence measures up to the fourth visits and received rewards. Mean study duration was 281 days, with 7/10 participants unable to attend their fourth visit due to COVID-19 lockdown. Only 3/10 participants managed to pair the app/EMD up to the fourth visit, which was associated with improved ICS adherence (from 0.51, SD 0.07 to 0.86, SD 0.05). Adherence did not change in adolescents unable to pair the app/EMD. The intervention was acceptable to participants and parents/guardians. Exit interviews showed that participants welcomed reminders and incentives, though expressed frustration with app/EMD technological difficulties. Participants stated the intervention helped through reminding ICS doses, promoting self-monitoring and increasing motivation to take inhalers.ConclusionsAn intervention using electronic reminders and incentives through an app coupled with an EMD was feasible and acceptable to adolescents with asthma. A pilot randomised controlled trial is warranted to better estimate the effect size on adherence, with improved technical support for the EMD.

Background: Allergen immunotherapy (AIT) is the only causal treatment for respiratory allergy. Long-term real-life effectiveness of AIT remains to be demonstrated beyond the evidence from randomised controlled trials (RCTs). Methods: REACT (Real world effectiveness in allergy immunotherapy) is a retrospective cohort study using claims data between 2007 and 2017. Study eligibility was a confirmed diagnosis of allergic rhinitis (AR), with or without asthma, and AIT. To ensure comparable groups, AIT-treated subjects were propensity score matched 1:1 with control subjects, using characteristic and potential confounding variables. Outcomes were analysed as within (pre vs post AIT) and between (AIT vs control) group differences across 9 years of follow-up (ClinicalTrial.gov: NCT04125888). Findings: 46,024 AIT-treated subjects were matched with control subjects and 14,614 were included in the pre-existing asthma cohort. AIT-treated subjects were 29·5 (16·3) years and 53% were male. Compared to pre-index year, AIT was consistently associated with greater reductions compared to control subjects in AR and asthma prescriptions, including both asthma controller and reliever prescriptions. Additionally, the AIT group had significantly greater likelihood of stepping down asthma treatment (P

Background Whether concomitant home exposures modify the effectiveness of mouse allergen reduction among mouse-sensitized children with asthma is unknown. Objective To determine whether a lower baseline home mouse allergen level, lower particulate matter 10 μ or less (PM10), and the absence of sensitization and exposure to other indoor allergens are associated with greater improvements in asthma associated with mouse allergen reduction. Methods A secondary analysis of a randomized clinical trial of a home mouse allergen intervention was performed to examine the effect of 3 indoor factors on the relationship between mouse allergen reduction and a range of asthma outcomes. Results Participants (N = 297) were predominantly minority (78% African American, 22% Hispanic) and publicly insured (88%). Higher baseline mouse allergen levels were associated with a greater response to mouse allergen reduction for several symptom and exacerbation outcomes. Lower indoor PM10 levels were associated with a greater response to mouse allergen reduction for several symptom outcomes, but not exacerbation outcomes. Overall, sensitization and exposure to other indoor allergens did not appear to modify the effect of mouse allergen reduction. Conclusions In this population of predominantly low-income children with persistent asthma and mouse sensitization, mouse allergen reduction was associated with improvements in asthma, especially among those with high baseline mouse allergen exposure. Lower indoor PM10 was associated with greater improvements in asthma symptoms.