Methods used in clinical development of novel anti-asthma therapies.

Abstract:

:In recent years, it has become increasingly important to get as much as possible information on clinical efficacy already in the early phases of drug development. For proof of concept (POC) studies testing novel anti-inflammatory drugs in asthma, there are several validated exacerbation models, inducing various aspects of the airway inflammation and airway responsiveness. The choice of the appropriate asthma model depends on the drug's targets within the inflammatory process. For adequate assessment of the drug's anti-inflammatory potential, it is crucial to choose adequate (surrogate) biomarkers. Ideally, these should include measures of airway response, central and peripheral airway inflammation and airway hyperresponsiveness. Overall, there are validated non-invasive sampling techniques for the measurement of inflammatory markers in asthma that can be applied as outcome parameters in early clinical trials. If adequately implemented, these measurements can provide early indication of proof of pharmacological and potential therapeutic efficacy-even in first administration to humans.

journal_name

Respir Med

journal_title

Respiratory medicine

authors

Diamant Z,Boot D,Kamerling I,Bjermer L

doi

10.1016/j.rmed.2007.10.018

subject

Has Abstract

pub_date

2008-03-01 00:00:00

pages

332-8

issue

3

eissn

0954-6111

issn

1532-3064

pii

S0954-6111(07)00441-6

journal_volume

102

pub_type

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