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Methods used in clinical development of novel anti-asthma therapies

Diamant, Zuzana; Boot, Diderik; Kamerling, Ingrid and Bjermer, Leif LU (2008) In Respiratory Medicine 102(3). p.332-338
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,... (More)
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. (C) 2007 Elsevier Ltd. All rights reserved. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
exacerbation models, asthma, early clinical trials, inflammometry
in
Respiratory Medicine
volume
102
issue
3
pages
332 - 338
publisher
Elsevier
external identifiers
  • wos:000253637500003
  • scopus:38749113369
ISSN
1532-3064
DOI
10.1016/j.rmed.2007.10.018
language
English
LU publication?
yes
id
a4c344cd-0c9b-4544-aaca-7f4d741041f5 (old id 1191698)
date added to LUP
2008-09-05 11:26:43
date last changed
2017-01-01 05:20:25
@article{a4c344cd-0c9b-4544-aaca-7f4d741041f5,
  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. (C) 2007 Elsevier Ltd. All rights reserved.},
  author       = {Diamant, Zuzana and Boot, Diderik and Kamerling, Ingrid and Bjermer, Leif},
  issn         = {1532-3064},
  keyword      = {exacerbation models,asthma,early clinical trials,inflammometry},
  language     = {eng},
  number       = {3},
  pages        = {332--338},
  publisher    = {Elsevier},
  series       = {Respiratory Medicine},
  title        = {Methods used in clinical development of novel anti-asthma therapies},
  url          = {http://dx.doi.org/10.1016/j.rmed.2007.10.018},
  volume       = {102},
  year         = {2008},
}