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E-cigarettes are primarily used by teenagers and young adults. Flavors in e-cigarettes increase their attractiveness and encourage young people and adults to start using them. This exposes young people in particular to the risk of nicotine addiction and various toxic substances from the aerosol of e-cigarettes. There are indications that various flavors in e-cigarettes are harmful to health, although toxicological studies are still lacking for the majority of flavors. There is a need for independent scientific investigations in this area. The scientific societies involved are calling for a ban on flavors in e-cigarettes, a ban on disposable e-cigarettes, effective regulation of the sale of e-cigarettes and effective control and implementation of the provisions for the protection of minors.
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Sistemas Eletrônicos de Liberação de Nicotina , Aromatizantes , Sociedades Médicas , Alemanha , Humanos , Pneumologia/legislação & jurisprudênciaRESUMO
INTRODUCTION: There is an interest in the role of blood eosinophils for predicting inhaled corticosteroid (ICS) response in chronic obstructive pulmonary disease (COPD). Most data are from interventional clinical studies; data from unselected real-world populations may help better inform treatment decisions. DACCORD is a non-interventional real-world study. Cohort 3 recruited patients with COPD who had received triple therapy for ≥ 6 months; prior to entry patients either continued triple therapy, or switched to a long-acting muscarinic antagonist/long-acting beta2-agonist (LABA/LAMA), and were followed for 12 months. METHODS: For these post-hoc analyses, patients were divided into four groups based on exacerbation history and baseline blood eosinophil count (< 100 vs. > 300 cells/µL). Exacerbation rates were calculated overall and for the two treatments. RESULTS: Among the 430 patients in the current analyses, the largest groups had low exacerbation history with high (44.2%) or low eosinophils (36.7%). Most patients did not exacerbate during follow-up (68.8% overall; 83.2% and 63.7% with LABA/LAMA and triple therapy). The highest exacerbation rates were in groups with high exacerbation history, differing significantly in the overall analyses from those with low exacerbation history (matched by eosinophil count); rates did not differ when grouped by eosinophil count (matched by exacerbation history). CONCLUSIONS: Although most patients in these analyses did not exacerbate during follow-up, whereas exacerbation history is a predictor of future exacerbations, blood eosinophil count is not. This suggests that although eosinophil count may help to guide ICS initiation, this is less of a consideration when 'stepping-down' from triple therapy to a LABA/LAMA.
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Eosinófilos , Doença Pulmonar Obstrutiva Crônica , Humanos , Quimioterapia Combinada , Agonistas de Receptores Adrenérgicos beta 2 , Administração por Inalação , Progressão da Doença , Doença Pulmonar Obstrutiva Crônica/diagnóstico , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Doença Pulmonar Obstrutiva Crônica/induzido quimicamente , Antagonistas Muscarínicos , Corticosteroides/uso terapêutico , BroncodilatadoresRESUMO
Chronic cough (i.e., cough lasting >8 weeks) has a global prevalence of approximately 10%. The individual burden can be long-lasting, with some patients experiencing cough for many years. Although chronic cough is often a symptom of respiratory diseases (e.g., lung cancer, tuberculosis, chronic obstructive pulmonary disease) or associated with triggers (e.g., asthma, gastroesophageal reflux disease, rhinosinusitis) and may resolve after targeted treatment of these conditions, some patients continue to cough despite optimal treatment (refractory chronic cough, RCC) or have no identifiable conditions presumed to be contributing to the cough (unexplained chronic cough, UCC). In patients with chronic cough, it is critical to perform a thorough initial patient assessment with adherence to a diagnostic algorithm (e.g., of the German Respiratory Society Cough Guidelines) to identify the cause of the symptom cough and provide appropriate treatment; or diagnose RCC and UCC. Primary care physicians should provide the initial diagnostic workup of patients with chronic cough (history, physical exam, chest X-ray and spirometry). If no cause of the cough can be identified, referral to specialists (e.g., pulmonologists, gastroenterologists, otolaryngologists) may be appropriate. Increased appreciation of chronic cough as a distinct condition, rather than as only a symptom of other diseases, may help overcome current challenges in diagnosing and managing chronic cough.
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Asma , Carcinoma de Células Renais , Neoplasias Renais , Doença Pulmonar Obstrutiva Crônica , Humanos , Tosse/diagnóstico , Tosse/etiologia , Tosse/terapiaRESUMO
INTRODUCTION: Chronic obstructive pulmonary disease (COPD) guidelines recommend reserving triple therapy of inhaled corticosteroid (ICS), long-acting ß2-agonist (LABA) and long-acting muscarinic antagonist (LAMA) for patients with exacerbations despite dual therapy. However, many patients receive triple therapy without a clear indication. For these patients, it would be useful to know whether ICS can be withdrawn. METHODS: DACCORD was a longitudinal, non-interventional 'real-world' study in three cohorts. This manuscript describes the results of Cohort 3, which recruited patients with COPD who had received triple therapy for ≥ 6 months. Prior to entry, each patient's physician decided to continue triple therapy, or switch to a LABA/LAMA; patients were then followed for 12 months, with exacerbations and COPD Assessment Test (CAT) data recorded every 3 months. The primary endpoint was the time until COPD worsening, defined as the occurrence of a moderate/severe exacerbation or clinically relevant CAT worsening. RESULTS: Of the 1192 patients recruited into the study, 967 completed the end-of-study visit and ≥ 2 of the three interim visits, 292 and 675 receiving LABA/LAMA and triple therapy, respectively. Most baseline demographics were similar between the two groups. A lower proportion of patients in the LABA/LAMA group had COPD worsening than with triple therapy (32.5% vs 55.7% at 12 months), with the time to worsening extended in the LABA/LAMA group (hazard ratio 2.004, p < 0.001). In addition, a significantly lower proportion of patients in the LABA/LAMA group exacerbated (18.5% vs 28.7%; p < 0.001), accompanied by a greater improvement from baseline in CAT total score. Overall, fewer patients in the LABA/LAMA group reported adverse events than in the triple therapy group (12.9% vs 15.1%). CONCLUSIONS: These results suggest that in a real world setting physicians are able to identify patients who can be 'stepped down' from triple therapy to LABA/LAMA. Following step down, there was no overall decline in COPD-indeed, some patients had better outcomes.
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Agonistas de Receptores Adrenérgicos beta 2 , Doença Pulmonar Obstrutiva Crônica , Administração por Inalação , Corticosteroides/efeitos adversos , Agonistas de Receptores Adrenérgicos beta 2/efeitos adversos , Quimioterapia Combinada , Humanos , Antagonistas Muscarínicos/efeitos adversos , Doença Pulmonar Obstrutiva Crônica/complicações , Doença Pulmonar Obstrutiva Crônica/diagnóstico , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológicoRESUMO
BACKGROUND: Overuse of short-acting beta-2 agonists (SABA), which do not treat the underlying inflammation of asthma, is linked to poor clinical outcomes such as increased exacerbation risk. This study, as part of the SABINA program, estimated the prevalence of SABA overuse and associated variables in outpatients in Germany. METHODS: This retrospective study used anonymized electronic healthcare data from the Disease Analyzer database (IQVIA). A total of 15,640 patients aged ≥ 12 years with asthma who received ≥ 1 SABA prescription(s) between July 2017 and June 2018 in 924 general physician and 22 pneumologist (PN) practices were included. SABA overuse was defined as ≥ 3 prescribed inhalers (~ 200 puffs each) during the study period. The associations between SABA overuse and physician specialty, Global Initiative for Asthma (GINA) steps (based on asthma medications), age, sex, and inhaled corticosteroid (ICS)/long-acting beta agonist (LABA) use were estimated using multivariable regression for patients with probable moderate (GINA step 2) and probable severe (GINA steps 3-5) asthma. RESULTS: Annually, 36% of all patients (GINA steps 1-5) in general and 38% in PN practices received ≥ 3 SABA inhalers. The risk of SABA overuse was 14% higher in patients treated by a general practitioner vs. a PN; 34% and 85% higher in GINA steps 4 and 5, respectively, vs. GINA step 3; and 40% higher in male vs. female patients. CONCLUSIONS: SABA overuse is prevalent among patients with asthma across all GINA steps in Germany, which may indicate suboptimal asthma control. Further studies are needed to investigate the reasons behind SABA overuse.
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Agonistas de Receptores Adrenérgicos beta 2/administração & dosagem , Asma/epidemiologia , Uso Excessivo de Medicamentos Prescritos/tendências , Administração por Inalação , Adolescente , Adulto , Idoso , Asma/tratamento farmacológico , Criança , Estudos Transversais , Feminino , Alemanha/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Prevalência , Estudos Retrospectivos , Adulto JovemRESUMO
OBJECTIVE: To facilitate distinction between asthma and chronic obstructive pulmonary disease (COPD) in day-to-day primary care practice, and provide practical treatment strategies using spirometric cases to outline how to recognize the clinical and spirometric overlap between asthma and COPD. SOURCES OF INFORMATION: The approaches described here were developed using evidence-based guidelines and the expertise of the authors, including research findings by the authors in the areas of asthma, COPD management, and spirometric testing in primary care. MAIN MESSAGE: There are patients with clinical or spirometric features of both asthma and COPD. Both asthma and COPD are associated with some degree of inflammation of the respiratory tract, mediated by the increased expression of inflammatory proteins. However, there are clear differences between asthma and COPD in the pattern of inflammation that occurs in the lungs. Diagnostic confusion between COPD and asthma is most likely to arise in older patients with respiratory complaints, particularly against a background that includes cigarette smoke or workplace exposure. Both asthma and COPD are clinical diagnoses based on patient history, symptoms, physical examination findings, and objective measures of lung function. Postbronchodilator spirometry is always needed to confirm a new diagnosis of COPD and should also be performed prebronchodilator for the diagnosis of asthma. However, in many cases, the interpretation of spirometry results is not straightforward. CONCLUSION: Understanding the nature and extent of the spirometric overlap between asthma and COPD is critical for tailoring a therapeutic strategy that is based on factors that include medical and family history, signs and symptoms, and a clear interpretation of spirometry data. This information will be leveraged differently for individual patients to arrive at the correct clinical diagnosis and to select the most appropriate therapy.
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Asma , Doença Pulmonar Obstrutiva Crônica , Idoso , Asma/diagnóstico , Humanos , Pulmão , Atenção Primária à Saúde , Doença Pulmonar Obstrutiva Crônica/diagnóstico , EspirometriaRESUMO
The model presented by Lee and Schwarz provides a novel explanation for the elementary mechanisms of psychological cleansing. I argue that the model could be extended to account for complex instances of psychological cleansing where the grounded procedures are not isolated and the opposing motives of separation and connection are entangled in a strategic interplay.
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Motivação , Teoria Fundamentada , HumanosRESUMO
PURPOSE: A number of analyses have shown the immediate impact of COPD exacerbations on health status. However, none evaluated the long-term correlation between health status and the occurrence of exacerbations. METHODS: DACCORD is an observational study in patients with COPD recruited across Germany following initiation or change in COPD maintenance medication. Data collected include COPD Assessment Test (CAT) total score on entry and after 1 and 2 years, and the occurrence of exacerbations. We analysed the correlation between change from baseline in CAT total score and exacerbations, after excluding patients who exacerbated during the quarter immediately prior to the CAT assessment of interest. RESULTS: The initial correlation analysis was performed in 6075 patients, 28% with ≥ 1 exacerbation over the 2-year follow-up, and 58% with a clinically relevant CAT improvement. There was a significant correlation between exacerbations over 2 years and CAT change from baseline at Year 2 (p = 0.0041). The Spearman's correlation coefficient was 0.03711, indicating very weak correlation-potentially driven by the high proportion of non-exacerbating patients. In a subsequent logistic regression, the probability of experiencing frequent (≥ 2 per year) or severe exacerbations was higher in patients with worsening in CAT total score (p < 0.001). However, the probability of a patient exacerbating in Year 1 or Year 2 did not correlate with CAT change. CONCLUSIONS: In this population (initiating or changing maintenance COPD medication), patients with frequent or severe exacerbations had a long-term worsening in health status (beyond the acute effect of an exacerbation) compared with patients who do not exacerbate.
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Volume Expiratório Forçado/fisiologia , Nível de Saúde , Doença Pulmonar Obstrutiva Crônica/epidemiologia , Idoso , Progressão da Doença , Feminino , Seguimentos , Alemanha/epidemiologia , Humanos , Masculino , Morbidade/tendências , Estudos Prospectivos , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Índice de Gravidade de DoençaRESUMO
BACKGROUND: The fixed-dose combination of budesonide/formoterol (B/F) has been available in the Spiromax® dry powder inhaler since 2014. OBJECTIVES: To assess patient satisfaction, inhaler use errors, and disease control in patients with asthma or chronic obstructive pulmonary disease (COPD) treated with B/F Spiromax. METHODS: This non-interventional, prospective, 12-week study enrolled consecutive asthma or COPD patients who had recently begun treatment with B/F Spiromax or were switched from another inhaled corticosteroid/long-acting ß2-agonist combination to B/F Spiromax in routine clinical practice. Patients recruited from 243 specialist respiratory clinics or general practices in Germany were assessed for patient satisfaction (Satisfaction with Inhalers and Preference questionnaire), inhaler application errors (modified Easy Low Instruction over Time checklist), disease control, and safety. RESULTS: The population included 3,943 patients: asthma n = 2,707 (68.7%); COPD n = 1,236 (31.3%). At baseline, 60.1% of patients were "satisfied" or "very satisfied" with their previous inhaler, and this increased to 88.8% at week 12 of B/F Spiromax use. Overall, 62.1% of pre-treated patients preferred B/F Spiromax to their old inhaler. The frequency of any handling error observed with B/F Spiromax at week 12 was lower than at baseline (11.9 vs. 25.5% of patients, respectively). After 12 weeks, 77.4% were assessed as having improved (minimally, much, or very much) overall health status versus baseline. Guideline-defined disease severity (as rated by physicians) and patient-reported symptom severity improved during the study in both asthma and COPD patients. B/F Spiromax was well tolerated. CONCLUSION: B/F Spiromax was associated with high patient satisfaction, low device handling error rate, and improvements in clinical outcomes in real-world clinical practice.
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Antiasmáticos/uso terapêutico , Asma/tratamento farmacológico , Combinação Budesonida e Fumarato de Formoterol/uso terapêutico , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Adulto , Idoso , Substituição de Medicamentos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente/estatística & dados numéricos , Estudos Prospectivos , Resultado do TratamentoRESUMO
OBJECTIF: Faciliter la distinction entre l'asthme et la maladie pulmonaire obstructive chronique (MPOC) en pratique de première ligne de tous les jours, et fournir des stratégies thérapeutiques pratiques à l'aide de cas de spirométrie pour illustrer comment reconnaître le chevauchement clinique et spirométrique entre l'asthme et la MPOC. SOURCES D'INFORMATION: Les approches décrites ici s'appuient sur les lignes directrices factuelles et sur l'expertise des auteurs, y compris des observations de recherches menées par les auteurs dans les domaines de l'asthme, de la prise en charge de la MPOC et des examens de spirométrie en première ligne. MESSAGE PRINCIPAL: Certains patients présentent des caractéristiques cliniques communes à l'asthme et à la MPOC. Ces deux maladies sont associées à un certain degré d'inflammation des voies respiratoires, médiée par l'expression accrue de protéines inflammatoires. Il existe toutefois des différences évidentes entre l'asthme et la MPOC pour ce qui est de l'inflammation présente dans les poumons. La confusion diagnostique entre la MPOC et l'asthme survient le plus souvent chez les patients âgés qui se plaignent de symptômes respiratoires, surtout en contexte de tabagisme ou d'exposition professionnelle. Les diagnostics cliniques d'asthme et de MPOC sont fondés sur les antécédents du patient, les symptômes, l'examen physique et les mesures objectives de la fonction respiratoire. La spirométrie après bronchodilatation est toujours nécessaire pour confirmer un nouveau diagnostic de MPOC et elle doit également être réalisée avant la bronchodilatation pour poser un diagnostic d'asthme. Dans de nombreux cas, toutefois, il n'est pas évident d'interpréter les résultats de la spirométrie. CONCLUSION: Il est essentiel de bien comprendre la nature et la portée du chevauchement spirométrique entre l'asthme et la MPOC afin de concevoir une stratégie thérapeutique qui s'appuie sur des facteurs qui incluent les antécédents médicaux et familiaux, les signes et les symptômes, et l'interprétation claire des données de spirométrie. Cette information sera utilisée différemment auprès de chaque patient pour arriver au bon diagnostic clinique et sélectionner le traitement le plus approprié.
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This phase 2/3 randomised, parallel-group, placebo-controlled trial investigated oral corticosteroid (OCS)-sparing efficacy, safety and tolerability of nebulised budesonide (Bud) administered with a novel computer-controlled, compressor-driven inhalation system (AKITA) as add-on therapy to Global Initiative for Asthma step 5. Patients (18-65 years) with OCS-dependent asthma were randomised (2:1:1:1) to receive 18-week, twice-daily, double-blind treatment with AKITA inhaled corticosteroid (AICS)-Bud 1â mg, AICS-Bud 0.5â mg, AICS-placebo or open-label Bud 1â mg administered by conventional nebuliser (CN-Bud). OCS doses were tapered until week 14. 199 patients started treatment. More AICS-Bud 1â mg (80.0%) than placebo-treated (62.5%) patients had daily OCS doses reduced ≥50%, with clinical stability to week 18 (one-sided p=0.02; treatment difference: 17.5% (95% CI 0.1-34.9%), two-sided p=0.04). Mean±sd forced expiratory volume in 1â s improved (from baseline to week 18) for AICS-Bud 1â mg (239±460â mL, p<0.001) and AICS-Bud 0.5â mg (126±345â mL, p=0.01) but not placebo (93±419â mL, p=0.36) or CN-Bud (137±459â mL, p=0.18). Fewer AICS-Bud 1â mg-treated patients experienced asthma exacerbations (7.5%) compared with placebo (17.5%) or CN-Bud (22.5%). All treatments were well tolerated. Budesonide applied with AKITA allowed significant meaningful OCS reduction in OCS-dependent asthma patients while improving pulmonary function and maintaining exacerbation control.
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Asma/tratamento farmacológico , Budesonida/administração & dosagem , Nebulizadores e Vaporizadores , Esteroides/administração & dosagem , Administração por Inalação , Administração Oral , Adolescente , Adulto , Idoso , Antiasmáticos/administração & dosagem , Broncodilatadores/administração & dosagem , Método Duplo-Cego , Esquema de Medicação , Sistemas de Liberação de Medicamentos/instrumentação , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Segurança do Paciente , Prednisona/administração & dosagem , Resultado do Tratamento , Adulto JovemRESUMO
BACKGROUND: A variety of large randomized controlled trials (RCT's) evaluating pharmacotherapy in chronic obstructive pulmonary disease (COPD) patients does exist. One of the drugs that has been tested is the new long-acting anticholinergic glycopyrronium bromide. METHODS: As the generalizability of results from RCT's is questionable we designed a longitudinal, prospective non-interventional study (DACCORD) of two years duration plus two years extension with at least 6000 participants in approximately 500 primary and secondary care practices in Germany (within the new established COPD National Prospective Registry), to assess patient reported outcomes (PRO's), lung function, adherence and drug safety. To circumvent the hurdle of inappropriate COPD diagnosis in a non-interventional trial, patients have to fulfill the inclusion criteria of the COPD disease management program (DMP) of the German statutory health insurances. Patient management should follow the German national COPD guidelines, which are based on Global Initiative for Chronic Obstructive Lung Disease 2007 (GOLD) report. Labels of prescribed drugs should also be taken into account. Patients received treatment as part of their standard care: at the discretion of the investigator patients were included in one of two arms. A: standard care with glycopyrronium containing regimen, and arm B: standard care without glycopyrronium. DISCUSSION: For 2016 we expect important results regarding longitudinal development of PRO's including exacerbations, lung function, adherence and side effects. We also investigate applicability of the new GOLD staging system in usual care. Data on diagnostic and treatment modalities in current German primary and secondary care, as well as pharmaco-economic data will be generated. TRIAL REGISTRATION: 1. German Register for non-interventional studies: http://www.vfa.de/de/arzneimittel-forschung/datenbanken-zu-arzneimitteln/nisdb . 2. EMA EnCePP http://www.encepp.eu/ .
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Agonistas de Receptores Adrenérgicos beta 2/uso terapêutico , Broncodilatadores/uso terapêutico , Glicopirrolato/uso terapêutico , Pacientes Ambulatoriais , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Sistema de Registros , Adulto , Feminino , Seguimentos , Alemanha , Humanos , Masculino , Estudos Prospectivos , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Resultado do TratamentoRESUMO
BACKGROUND: Gastroesophageal reflux disease (GERD) is one of the most frequent benign disorders of the upper gastrointestinal tract. Management of GERD has always been controversial since modern medical therapy is very effective, but laparoscopic fundoplication is one of the few procedures that were quickly adapted to the minimal access technique. The purpose of this project was to analyze the current knowledge on GERD in regard to its pathophysiology, diagnostic assessment, medical therapy, and surgical therapy, and special circumstances such as GERD in children, Barrett's esophagus, and enteroesophageal and duodenogastroesophageal reflux. METHODS: The European Association of Endoscopic Surgery (EAES) has tasked a group of experts, based on their clinical and scientific expertise in the field of GERD, to establish current guidelines in a consensus development conference. The expert panel was constituted in May 2012 and met in September 2012 and January 2013, followed by a Delphi process. Critical appraisal of the literature was accomplished. All articles were reviewed and classified according to the hierarchy of level of evidence and summarized in statements and recommendations, which were presented to the scientific community during the EAES yearly conference in a plenary session in Vienna 2013. A second Delphi process followed discussion in the plenary session. RESULTS: Recommendations for pathophysiologic and epidemiologic considerations, symptom evaluation, diagnostic workup, medical therapy, and surgical therapy are presented. Diagnostic evaluation and adequate selection of patients are the most important features for success of the current management of GERD. Laparoscopic fundoplication is the most important therapeutic technique for the success of surgical therapy of GERD. CONCLUSIONS: Since the background of GERD is multifactorial, the management of this disease requires a complex approach in diagnostic workup as well as for medical and surgical treatment. Laparoscopic fundoplication in well-selected patients is a successful therapeutic option.
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Fundoplicatura/normas , Refluxo Gastroesofágico/diagnóstico , Refluxo Gastroesofágico/terapia , Laparoscopia/normas , Sociedades Médicas/normas , Adulto , Antiácidos/uso terapêutico , Esôfago de Barrett/diagnóstico , Criança , Diagnóstico Diferencial , Endoscopia do Sistema Digestório , Monitoramento do pH Esofágico , Europa (Continente) , Fundoplicatura/métodos , Antagonistas dos Receptores H2 da Histamina/uso terapêutico , Humanos , Manometria/métodos , Seleção de Pacientes , Inibidores da Bomba de Prótons/administração & dosagem , RecidivaRESUMO
INTRODUCTION: Common cold (CC) symptoms arise from an inflammatory response treatable with cineole and generally peak within two days, which complicates research implementation. We therefore explored the benefits of early cineole administration with enrolment of participants prior to CC onset. METHODS: Out of 522 adults enrolled in our phase IV, open-label, non-randomized, exploratory clinical trial (EudraCT No. 2020-000860-51), 329 developed a CC and used 200 mg cineole (Soledum®, CNL-1976) t.i.d. for max. 15 (± 2) days. Primary endpoint was burden of disease based on the Wisconsin Upper Respiratory Symptom Survey (WURSS-11). RESULTS: Comparing three strata based on time to treatment (≤ 12 h, > 12 to ≤ 24 h and > 24 h), earliest treatment resulted in lowest AUC-WURSS (Spearman correlation coefficient of 0.36) and reduced the overall burden of disease by 38% (p < 0.0001). Earlier and lower symptom severity peak resulted, with shorter time to remission (average 8.9 vs. 10.7 days with latest treatment initiation, p < 0.05), and higher and faster recovering quality of life (p < 0.05). Tolerability was mostly rated as "very good", with adverse events of suspected causal relationship reported in 4.3% of participants. CONCLUSIONS: Early intervention shows clinical benefits relevant for the effective treatment of CC with cineole.
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Resfriado Comum , Adulto , Humanos , Resfriado Comum/tratamento farmacológico , Resfriado Comum/complicações , Eucaliptol , Qualidade de Vida , Índice de Gravidade de Doença , Inquéritos e QuestionáriosRESUMO
BACKGROUND: Evidence on how decisions regarding escalation to triple therapy and de- or re-escalation are taken and the rationale on which these decisions are based is currently limited in Germany. OBJECTIVES: The TETRIS study aims to elucidate influences on treatment decisions surrounding triple therapy in a real-world practice setting in Germany. DESIGN: TETRIS is an ongoing, multicenter, prospective, observational cohort study recruiting patients with chronic obstructive pulmonary disease (COPD) with or without asthma who have already been treated with triple therapy for 2-48 weeks. METHODS: For better representation of the treatment reality in Germany, patients are recruited from general practitioners and pulmonologists. Data are collected in two parts. Part 1 involves cross-sectional phenotyping of patients at enrollment. Part 2 involves a 2-year longitudinal follow-up period to monitor/document all visits by the patients during the 24-month observation period per routine clinical practice. Here, we report the demographic and baseline characteristics of 1213 eligible patients recruited to part 1 of the study. RESULTS: The mean patient age was 66.4 years overall, and 29.3% (356/1213) of patients had no comorbidities. The mean CAT score was 19.4; the number of exacerbations and hospitalizations due to exacerbations in the past 3 years before starting triple therapy was 0.6 and 0.1, respectively. Dual bronchodilation with a long-acting muscarinic antagonist (LAMA) plus a long-acting ß-2 agonist (LABA) was the most common therapy for COPD before initiation of triple therapy in 58.3% of patients. CONCLUSION: In this real-world setting in Germany, patients with COPD have a relatively low reported exacerbation rate but high symptom burden, and over 70% are multimorbid. Triple therapy is initiated in patients who are primarily highly symptomatic despite being on LAMA + LABA. Future prospective studies in patients with multimorbidity are warranted to better understand the treatment landscape across the disease spectrum. TRIAL REGISTRATION: https://clinicaltrials.gov/study/NCT04657211.
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Broncodilatadores , Quimioterapia Combinada , Doença Pulmonar Obstrutiva Crônica , Humanos , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Doença Pulmonar Obstrutiva Crônica/diagnóstico , Doença Pulmonar Obstrutiva Crônica/epidemiologia , Masculino , Feminino , Alemanha , Estudos Prospectivos , Idoso , Pessoa de Meia-Idade , Broncodilatadores/administração & dosagem , Broncodilatadores/uso terapêutico , Resultado do Tratamento , Estudos Transversais , Agonistas de Receptores Adrenérgicos beta 2/administração & dosagem , Agonistas de Receptores Adrenérgicos beta 2/uso terapêutico , Antagonistas Muscarínicos/administração & dosagem , Fatores de Tempo , Estudos Longitudinais , Pulmão/efeitos dos fármacos , Pulmão/fisiopatologia , Progressão da Doença , Tomada de Decisão Clínica , Padrões de Prática MédicaRESUMO
BACKGROUND: Refractory or unexplained chronic cough (RCC or UCC) is difficult to manage and is usually treated by the off-label use of drugs approved for other indications. OBJECTIVE: The objectives of this systematic literature review (SLR) were to identify and characterize the current published body of evidence for the efficacy and safety of treatments for RCC or UCC. METHODS: The SLR was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The SLRs pre-defined population included patients ≥18 years of age who were diagnosed with chronic cough. The review was not restricted to any intervention type or study comparator, nor by timeframe. RESULTS: A total of 20 eligible publications from 19 unique trials were included. Seventeen of these trials were randomized controlled trials and most (14/17) were placebo-controlled. There was considerable variability between trials in the definition of RCC or UCC, participant exclusion and inclusion criteria, outcome measurement timepoints, and the safety and efficacy outcomes assessed. Several trials identified significant improvements in cough frequency, severity, or health-related quality of life measures while participants were on treatment, although these improvements did not persist in any of the studies that included a post-treatment follow-up timepoint. CONCLUSIONS: In the absence of an approved therapy, placebo remains the most common comparator in trials of potential RCC or UCC treatments. The between-study comparability of the published evidence is limited by heterogeneity of study design, study populations, and outcomes measures, as well as by concerns regarding study size and risk of bias.
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A panel of 24 international experts met in July 2022 to discuss challenges associated with pertussis detection, monitoring, and vaccination in adults; conclusions from this meeting are presented. There has been a shift in the epidemiology of pertussis toward older children and adults. This shift has been attributed to the waning of infection- or vaccine-induced immunity, newer detection techniques causing detection bias, and possibly the replacement of whole-cell pertussis with acellular vaccines in high-income countries, which may lead to immunity waning more quickly. The burden of adult pertussis is still likely under-ascertained due to widespread under-recognition by healthcare professionals (HCPs), under-diagnosis, and under-reporting in this age group. Non-standardized testing guidance and varied case definitions have contributed to under-reporting. Key barriers to HCP engagement with the tetanus, diphtheria, and pertussis (Tdap) vaccine include low awareness, lack of time/funding, and lack of motivation due to low prioritization of Tdap.
Assuntos
Vacinação , Coqueluche , Humanos , Coqueluche/prevenção & controle , Coqueluche/epidemiologia , Coqueluche/diagnóstico , Adulto , Vacinas contra Difteria, Tétano e Coqueluche Acelular/imunologia , Vacinas contra Difteria, Tétano e Coqueluche Acelular/administração & dosagem , Vacina contra Coqueluche/imunologia , Vacina contra Coqueluche/administração & dosagem , Administração em Saúde Pública/métodos , Saúde PúblicaRESUMO
Pertussis has several notable consequences, causing economic burden, increased strain on healthcare facilities, and reductions in quality of life. Recent years have seen a trend toward an increase in pertussis cases affecting older children and adults. To boost immunity, and protect vulnerable populations, an enduring approach to vaccination has been proposed, but gaps remain in the evidence surrounding adult vaccination that are needed to inform such a policy. Gaps include: the true incidence of pertussis and its complications in adults; regional variations in disease recognition and reporting; and incidence of severe disease, hospitalizations, and deaths in older adults. Better data on the efficacy/effectiveness of pertussis vaccination in adults, duration of protection, and factors leading to poor vaccine uptake are needed. Addressing the critical evidence gaps will help highlight important areas of unmet need and justify the importance of adult pertussis vaccination to healthcare professionals, policymakers, and payers.