Evaluation of New Drugs for Asthma and COPD: Endpoints, Biomarkers and Clinical Trial Design.

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Evaluation of New Drugs for Asthma and COPD: Endpoints, Biomarkers and Clinical Trial Design.

Handb Exp Pharmacol. 2016 Nov 13;

Authors: Singh D

Abstract
There remains a considerable need to develop novel therapies for patients with asthma and chronic obstructive pulmonary disease (COPD). The greatest challenge at the moment is measuring the effects of novel anti-inflammatory drugs, as these drugs often cause only small effects on lung function. Measurements that demonstrate the pharmacological and clinical effects of these drugs are needed. Furthermore, we now recognise that only subgroups of patients are likely to respond to these novel drugs, so using biomarkers to determine the clinical phenotype most suitable for such therapies is important. An endotype is a subtype of a (clinical) condition defined by a distinct pathophysiological mechanism. An endotype-driven approach may be more helpful in drug development, enabling drugs to be targeted specifically towards specific biological mechanisms rather than clinical characteristics. This requires the development of biomarkers to define endotypes and/or to measure drug effects. This newer approach should continue alongside efforts to optimise the measurement of clinical endpoints, including patient-reported outcome measurements, required by drug regulatory authorities.

PMID: 27838852 [PubMed – as supplied by publisher]

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[Biomarkers in asthma].

[Biomarkers in asthma].

Presse Med. 2016 May 25;

Authors: Taillé C, Bourdin A, Garcia G

Abstract
Identifying new biomarkers in asthma is attractive but requires assessing their relevance and their reliability to clinical practice. Beyond fashion, the improvement in identification of new candidate biomarkers benefited of scientific and biologic progresses, biobanks and platforms robustly backed on longitudinal cohorts and registries. Paradoxically, the main issue is now to stress up the good question, in other words to correctly characterize the unmet needs in asthma that might benefit of a biomarker. Chronicity, variability, weakness of diagnostic tools and the heterogeneity of the disease are features of asthma claiming for identifying new biomarkers. Unmet needs in asthma encompass areas such as diagnosis, prognosis, management and follow-up, therapeutic guidance and phenotypic/endotypic identification. FEV1 is an available biomarker largely tested in asthma worth in most of these areas. Albeit, mandatory features required for a new biomarker to emerge, pro/con debates on those already existing and currently used methods for identifying new ones are worth explorations. We reviewed and summarized the current literature focusing biomarkers in asthma.

PMID: 27236617 [PubMed – as supplied by publisher]

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Asthma Characteristics and Biomarkers From the Airways Disease Endotyping for … – Medscape

Asthma Characteristics and Biomarkers From the Airways Disease Endotyping for
Medscape
Methods: Patients with a range of asthma severity and healthy non-atopic controls were enrolled. The asthmatic subjects were followed for 12 months. Assessments included history, patient questionnaires, spirometry, airway hyper-responsiveness to …

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Current and future biomarkers in allergic asthma.

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Current and future biomarkers in allergic asthma.

Allergy. 2015 Dec 25;

Authors: Zissler UM, Bieren JE, Jakwerth CA, Chaker AM, Schmidt-Weber CB

Abstract
Diagnosis early in life, sensitization, asthma endotypes, monitoring of disease and treatment progression are key motivations for the exploration of biomarkers for allergic rhinitis and allergic asthma. The number of genes related to allergic rhinitis and allergic asthma increases steadily, however prognostic genes have not yet entered clinical application. We hypothesize that the combination of multiple genes may generate biomarkers with prognostic potential. The current review attempts to group more than 161 different potential biomarkers involved in respiratory inflammation to pave the way for future classifiers. The potential biomarkers are categorized into either epithelial or infiltrate-derived or mixed origin, epithelial biomarkers. Furthermore surface markers were grouped into cell-type specific categories. The current literature provides multiple biomarkers for potential asthma endotypes that are related to T cell phenotypes such as Th1, Th2, Th9, Th17, Th22 and Tregs and their lead cytokines. Eosinophilic and neutrophilic asthma endotypes are also classified by epithelium-derived CCL-26 and osteopontin, respectively. There are currently about 20 epithelium-derived biomarkers exclusively derived from epithelium, which are likely to innovate biomarker panels as they are easy to sample. This article systematically reviews and categorizes genes and collects current evidence that may promote these biomarkers to become part of allergic rhinitis or allergic asthma classifiers with high prognostic value. This article is protected by copyright. All rights reserved.

PMID: 26706728 [PubMed – as supplied by publisher]

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