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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New Data From GAP Landmark Trial Confirm GRAZAX® Prevents Asthma Symptoms in Children – PR Newswire (press release)

New Data From GAP Landmark Trial Confirm GRAZAX® Prevents Asthma Symptoms in Children
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The data, presented at the 2016 Annual Congress of the European Academy of Allergy and Clinical Immunology (EAACI) in Vienna, confirm that GRAZAX® can prevent asthma symptoms, as well as offering sustained relief from grass allergy symptoms.

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New Data From GAP Landmark Trial Confirm GRAZAX® Prevents Asthma Symptoms in Children – PR Newswire UK (press release)

New Data From GAP Landmark Trial Confirm GRAZAX® Prevents Asthma Symptoms in Children
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ALK (ALKB:DC / OMX: ALK B / AKABY / AKBLF) today presented new data from the GRAZAX® Asthma Prevention (GAP) trial with GRAZAX®, ALK's allergy immunotherapy tablet against grass pollen allergy. The data, presented at the 2016 Annual Congress …

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FierceMedicalDevices (press release) (registration)
Under the deal, Propeller and Molina will start a pilot trial focused on improving medication adherence, reducing symptoms and improving control for asthma patients. The healthcare system will use Propeller's platform to identify patients who are most

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AstraZeneca: Asthma drug trial results positive – MarketWatch


Reuters UK

AstraZeneca: Asthma drug trial results positive
MarketWatch
LONDON–AstraZeneca PLC (AZN.LN) said Tuesday its potential new medicine benralizumab showed positive results in a Phase III trial for asthma treatment. The treatment "was well tolerated and achieved the primary endpoint in two pivotal Phase III …
AstraZeneca boosted by good results for biotech asthma drugReuters UK
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Filipino accused in Lahad Datu intrusion trial succumbs to asthma – The Borneo Post

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KOTA KINABALU: A Filipino accused, described by his lawyer as having been ill throughout the ongoing Lahad Datu intrusion trial, succumbed to asthma attack on Saturday. Habil Suhaili, 68, died at 12.45pm at the Queen Elizabeth Hospital here. His
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