Effect of inhaled steroids on airway hyperresponsiveness, sputum eosinophils, and exhaled nitric oxide levels in patients with asthma

Rensen, Elizabeth L J van; Straathof, Karin; Veselic-Charvat, Maud; Zwinderman, A. H.; Bel, Elisabeth H.; Sterk, Peter J.

doi:10.1136/thx.54.5.403

Cited by 236 publications

(153 citation statements)

References 26 publications

(32 reference statements)

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“…However, all patients in the current stable asthma group were taking regular inhaled corticosteroids, and in steroid-treated patients the relationship between NO and sputum eosinophils is much less pronounced [27,28]. These two markers vary in their response to inhaled steroid treatment [30,31]. EBC pH has previously been reported to correlate with sputum eosinophils in asthma by KOSTIKAS et al [32].…”

Section: Discussionmentioning

confidence: 99%

Respiratory heat and moisture loss is associated with eosinophilic inflammation in asthma

Noble¹,

McCafferty²,

Greening³

et al. 2007

European Respiratory Journal

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Increased mucosal vascularity is a hallmark of airway inflammation in asthma. It was hypothesised that this would lead to a detectable increase in respiratory heat and moisture loss (RHML), which would reflect the degree of airway inflammation present.A total of 23 subjects with asthma and 18 healthy controls had RHML measured in a crosssectional study. The measurements were made using a device that combines temperature and humidity measurement during inspiration and expiration and allows precise control over inspirate conditions and ventilatory pattern. The subjects with asthma underwent parallel measurements of exhaled nitric oxide, sputum eosinophil percentage and exhaled breath condensate pH.Mean¡SD RHML was elevated in patients with asthma ( This novel correlation between thermal and cellular measurements in asthma suggests that both of these noninvasive indices are sensitive to the degree of underlying chronic airway inflammation.

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Section: Discussionmentioning

confidence: 99%

Respiratory heat and moisture loss is associated with eosinophilic inflammation in asthma

Noble¹,

McCafferty²,

Greening³

et al. 2007

European Respiratory Journal

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show abstract

“…In contrast, this correlation between the different markers of airway inflammation and airway hyperresponsiveness is lost in asthmatics using ICS [132,133]. This is probably due to a fast decrease of eNO attaining a maximal response even on low dose ICS therapy, resulting in almost normal eNO levels, while airway inflammation and hyperresponsiveness are still present.…”

Section: Exhaled No As a Biomarkermentioning

confidence: 47%

Biomarkers in asthma and allergic rhinitis

Diamant

Boot

Mantzouranis

et al. 2010

Pulmonary Pharmacology & Therapeutics

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“…All of these are clinically relevant, but each has drawbacks. For sputum eosinophilia, variability seems to be the main limitation [67], despite demonstration of dose-response relationship on clinically relevant doses [68]. Also, enough sputum must be produced in order be analyzed, and this may not be feasible for all patients.…”

Section: Pharmacodynamic (Pd) and Clinical Studiesmentioning

confidence: 99%

Regulatory Considerations for Approval of Generic Inhalation Drug Products in the US, EU, Brazil, China, and India

Lee

Saluja

García‐Arieta

et al. 2015

AAPS J

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Abstract. This article describes regulatory approaches for approval of Bgeneric^orally inhaled drug products (OIDPs) in the United States, European Union, Brazil, China and India. While registration of a generic OIDP in any given market may require some documentation of the formulation and device similarity to the Boriginal^product as well as comparative testing of in vitro characteristics and in vivo performance, the specific documentation approaches, tests and acceptance criteria vary by the country. This divergence is due to several factors, including unique cultural, historical, legal and economic circumstances of each region; the diverse healthcare and regulatory systems; the different definitions of key terms such as Bgeneric^and Breference^drug; the acknowledged absence of in vitro in vivo correlations for OIDPs; and the scientific and statistical issues related to OIDP testing (such as how best to account for the batch-to-batch variability of the Reference product, whether to use average bioequivalence or population bioequivalence in the statistical analysis of results, whether to use healthy volunteers or patients for pharmacokinetic studies, and which pharmacodynamic or clinical end-points should be used). As a result of this discrepancy, there are ample opportunities for the regulatory and scientific communities around the world to collaborate in developing more consistent, better aligned, science-based approaches. Moving in that direction will require both further research and further open discussion of the pros and cons of various approaches.

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Effect of inhaled steroids on airway hyperresponsiveness, sputum eosinophils, and exhaled nitric oxide levels in patients with asthma

Cited by 236 publications

References 26 publications

Respiratory heat and moisture loss is associated with eosinophilic inflammation in asthma

Respiratory heat and moisture loss is associated with eosinophilic inflammation in asthma

Biomarkers in asthma and allergic rhinitis

Regulatory Considerations for Approval of Generic Inhalation Drug Products in the US, EU, Brazil, China, and India

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