Dose response of FENO to inhaled steroids in mild-to-moderate asthma

• Research type

  Research Study

• Full title

  Dose response of FENO to inhaled steroids in mild-to-moderate asthma

• IRAS ID

  22051

• Contact name

  Peter A Williamson

• Eudract number

  2009-012053-37

• Research summary

  Asthma is a common inflammatory condition. Exhaled nitric oxide is an established tool for the assessment of asthmatic inflammation. It is non-invasive and easy to perform. It correlates to airway eosinophilia (the hallmark of asthmatic inflammation) and is readily suppressed with inhaled corticosteroids. Little is know about the diurnal variation of FENO over time and its response over time to inhaled corticosteroids. Asthma behaves differently in different people, with individuals expressing airway inflammation to differing degrees: some with elevated inflammatory surrogates (such as FENO) and others with increased airway smooth muscle sensitivity (reflected by increased bronchial hyperreactivity(BHR)). Indeed in clinical practice, some individuals express very high FENO levels without significant BHR and vice versa. Entry to clinical trials for asthma usually requires demonstration of BHR or reversibility to beta-agonists (such as 'Ventolin') and may therefore select individuals whom have a predominance of smooth muscle expression to their asthma (as opposed to high FENO expression). In such trials, FENO is usually suppressed very readily with relatively small doses of inhaled corticosteroids, even when BHR persists. As such, whilst a dose response to inhaled steroids has been shown in relation to BHR, it has been difficult to demonstrate with FENO. This may be in part due to selection bias to individuals with BHR. We therefore wish to examine the dose response to inhaled corticosteroids over time in individuals selected by a high expression of FENO. To establish changes over time and diurnal variation, FENO will be measured by the patients in their home using a portable FENO system designed for home use (MINO). Observed changes will be compared to other measures of disease including symptoms, systemic markers of inflammation and airway dynamic. It is hoped this will enhance our understanding of inflammatory surrogates, phenotypic expression of asthmatic disease and interpretation of clinical trial findings.

• REC name

  East of Scotland Research Ethics Service REC 2

• REC reference

  09/S0501/52

• Date of REC Opinion

  14 Aug 2009

• REC opinion

  Favourable Opinion