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2012, Journal of Allergy and Clinical Immunology
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15 pages
1 file
Asthma clinical research faces a lack of standardization in outcomes, which complicates the comparison and interpretation of data across studies. The consensus from various NIH institutes to establish standard definitions and methodologies aims to enhance the reliability of research findings. The proposed definitions for asthma exacerbations include criteria focusing on systemic corticosteroid use, healthcare utilization, and the need for nebulized bronchodilators, emphasizing the importance of a clear and consistent terminology. Moreover, severe and moderate exacerbations highlight the necessity of prompt medical intervention to avoid serious health outcomes. Reporting standards are suggested to facilitate clearer data aggregation and outcome assessment across diverse study populations.
Journal of Allergy and Clinical Immunology, 2009
Allergy, 2013
Asthma exacerbations and severe asthma are linked with high morbidity, significant mortality and high treatment costs. Recurrent asthma exacerbations cause a decline in lung function and, in childhood, are linked to development of persistent asthma. This position paper, from the European Academy of Allergy and Clinical Immunology, highlights the shortcomings of current treatment guidelines for patients suffering from frequent asthma exacerbations and those with difficult-to-treat asthma and severe treatment-resistant asthma. It reviews current evidence that supports a call for increased awareness of (i) the seriousness of asthma exacerbations and (ii) the need for novel treatment strategies in specific forms of severe treatment-resistant asthma. There is strong evidence linking asthma exacerbations with viral airway infection and underlying deficiencies in innate immunity and evidence of a synergism between viral infection and allergic mechanisms in increasing risk of exacerbations. Nonadherence to prescribed medication has been identified as a common clinical problem amongst adults and children with difficult-to-control asthma. Appropriate diagnosis, assessment of adherence and other potentially modifiable factors (such as passive or active smoking, ongoing allergen exposure, psychosocial factors) have to be a priority in clinical assessment of all patients with difficult-to-control asthma. Further studies with improved designs and new diagnostic tools are needed to properly characterize (i) the pathophysiology
BMC Pulmonary Medicine, 2008
Exacerbations are a major cause of morbidity in asthma and generate high health costs. Identification and management of adults with asthma who are prone to exacerbations is of considerable importance as by this means it should be possible to reduce the number of patients who currently experience inadequately controlled disease. Exacerbations occur most frequently in individuals with severe disease. Other risk factors include a history of a recent exacerbation, co-morbidities such as a raised body mass index and psychological problems as well as current smoking and lower socio-economic status. A low FEV1, particularly if combined with the additional information from questionnaires helps predict exacerbations. Despite the association between these risk factors and exacerbations it remains difficult to accurately predict in an individual patient with asthma whether they will go on to develop an exacerbation in the future. A major aim of international guidelines on the management of asthma is to prevent future risks of exacerbations, but some patients, particularly those with severe disease, respond poorly to current therapies and continue to experience recurrent exacerbations. There is an unmet need for improved management strategies and drugs targeted at preventing asthma exacerbations. Monitoring induced sputum eosinophil cell counts is helpful in preventing exacerbations in some patient with severe asthma. Future developments are likely to include the identification of better biomarkers to predict exacerbations or the cause of exacerbations, augmentation of the immunological response to viruses at the time of the exacerbation, the use of telemonitoring in patients with severe asthma and the development of improved therapies targeted at reducing exacerbations.
European Respiratory Journal
Despite the use of effective medications to control asthma, severe exacerbations in asthma are still a major health risk and require urgent action on the part of the patient and physician to prevent a serious outcome such as hospitalisation or death. Moreover, severe exacerbations are associated with substantial huge healthcare costs, and psychological burden including anxiety and fear for patients and their families. The European Academy of Allergy and Clinical Immunology (EAACI) and the European Respiratory Society (ERS) set up a Task Force (TF) to search for a clear definition of severe exacerbations and to also define research questions and priorities. The statement includes comments from patients who were members of the TF.
European Respiratory Journal
Despite the use of effective medications to control asthma, severe exacerbations in asthma are still a major health risk and require urgent action on the part of the patient and physician to prevent serious outcomes such as hospitalisation or death. Moreover, severe exacerbations are associated with substantial healthcare costs and psychological burden, including anxiety and fear for patients and their families. The European Academy of Allergy and Clinical Immunology (EAACI) and the European Respiratory Society (ERS) set up a task force to search for a clear definition of severe exacerbations, and to also define research questions and priorities. The statement includes comments from patients who were members of the task force.
Journal of Allergy and Clinical Immunology, 2006
In spite of the wide prevalence of asthma and its substantial consequences, the diagnosis and assessment of asthma has not been standardized, and the goals of therapy currently are not being achieved. Our purpose is to help delineate what the most important asthma end points are and what kinds of strategies we should use to guide therapy. Comparison of numerous studies reveals that asthma measures used routinely in the clinic, such as spirometric lung function, do not uniformly correlate with asthma control. We cannot improve outcomes until we determine which measures reveal the underlying disease process most clearly and at the same time offer ease of performance during routine office visits. We propose that by standardizing the way we collect and analyze data from our daily practice, we can better define which measures reflect true asthma control. Such measures most likely address a spectrum of changes occurring in the pathophysiology of asthma, notably distal airway inflammation and hyperresponsiveness. Inflammation may provide the best opportunity for assessment and treatment, because if it is adequately addressed, airway sensitivity may improve, thereby reducing airway obstruction and subsequently minimizing exacerbations. The fraction of exhaled nitric oxide as a measure of inflammation is suggested as offering the best combination of disease evaluation and practical implementation for improved asthma outcomes. (J Allergy Clin Immunol 2006;118:S1-15.)
Current Paediatrics, 2004
Although most children with asthma can easily be treated, a small minority have symptoms resistant to conventional therapy. Such children mandate a detailed re-evaluation. Alternative diagnoses should be considered, as well as factors which co-exist with asthma and may exacerbate the condition or be mistaken for uncontrolled asthma. Other important issues are the appropriateness of the drug delivery device; adverse environmental factors, including persistent allergen exposure and environmental tobacco smoke; and psychological factors, which include adherence to treatment. Finally, we suggest a detailed systematic approach to address the individual phenotype: for example, persistent airway eosinophilia, neutrophilia, or non-inflammatory. The protocol includes non-invasive measurement of airway inflammation and reactivity before and after systemic steroids, with bronchoscopy, lavage and biopsy at the end of the course. This approach leads us to develop an individual treatment plan. The validity of this approach needs to be tested in larger studies.
The Lancet. Respiratory medicine, 2017
Occurrence of severe asthma exacerbations are the cornerstone of the evaluation of asthma management, but severe asthma exacerbations are rare events. Therefore, trials that assess drug efficacy on exacerbations are done late in clinical development programmes. We aimed to establish an endpoint capturing clinically relevant deteriorations (diary events) that, when combined with severe exacerbations, create a composite outcome (CompEx). CompEx needs to strongly mirror results seen with the severe exacerbation-validated outcome, to allow the design of clinical trials of shorter duration and that include fewer patients than trials assessing severe exacerbations. Data from 12 asthma trials of 6 months or 12 months duration and, with standardised collection of exacerbations and diary card variables, were used to construct and test CompEx. The study populations had a mean age of 35-53 years, 59-69% were female, and had a mean FEV1 percentage of predicted normal of 63-84%. With data from f...
The Journal of allergy and clinical immunology, 2009
Disclosure of potential conflict of interest: M. Schatz has been a consultant for GlaxoSmithKline and has received research support from Aerocrine, Genentech, GlaxoSmithKline and Merck. A. A. N. Kazzi has declared that he had no conflict of interest. B. Brenner has declared that he had no conflict of interest. C. A. Camargo Jr has been a consultant, speaker, or advisory board member for AstraZeneca, Critical Therapeutics, Dey, Genentech, GlaxoSmithKline, Merck, Novartis, and Schering-Plough and has received research support from the National Institutes of Health, AstraZeneca, Critical Therapeutics, GlaxoSmithKline, Merck, Novartis, and Respironics. T. Corbridge is on the speakers' bureau for GlaxoSmithKline. J. A. Krishnan has declared that he had no conflict of interest. R. Nowak has declared that he had no conflict of interest. G. Rachelefsky has been a speaker or advisory board member for AstraZeneca, Schering-Plough, CSL Behring, Merck, and Sanofi Aventis and has provided legal consultation or expert witness testimony on the topic of environmental injuries, mostly mold-related. This article is part of the Joint Task Force Report: Supplemental Recommendations for the Management and Follow-up of Asthma Exacerbations, an official statement of the American Academy of Allergy, Asthma, and Immunology (AAAAI), the American Academy of Emergency Medicine (AAEM), and the American Thoracic Society (ATS).
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