A low exhaled nitric oxide level excludes a short-term benefit from inhaled corticosteroids in suspected asthma: A randomized placebo-controlled trial

Shaw, Dominick; Martin, Matthew J.; Sutherland, Lissa; Shaw, Karen; Parrish, Clair; Singleton, Nicola; McKeever, Tricia M.; Stewart, Iain; Harrison, Tim

Abstract

Background and objective: Fractional exhaled nitric oxide (FeNO) is a non-invasive biomarker that reflects IL-4/IL-13 production and therefore represents T2 allergic inflammation. FeNO has previously been used to guide inhaled corticosteroid (ICS) treatment in asthma. The purpose of this study was to determine if a low FeNO (≤27 ppb) could be used to reliably identify patients with symptoms suggestive of asthma who would not benefit from initiating treatment with an ICS. Methods: A total of 180 steroid-naïve adults with healthcare professional suspected asthma and an FeNO of ≤27 ppb were randomized to receive either 400 mcg of budesonide or placebo daily for 3 months. The primary outcome was the difference in the Asthma Control Questionnaire 7 (ACQ7) between treatment groups and the study was powered to determine equivalence. Secondary outcomes were the difference in FEV , Medical Research Council and Leicester Cough Questionnaire scores. Results: One hundred and thirty-four patients (68 budesonide and 66 placebo) completed the study and were included in the analysis. The between-group mean difference in ACQ7 from baseline to the end of the study was −0.25 and the 95% CI around this difference was −0.004 to 0.495 confirming equivalence (p < 0.05). Differences in forced expiratory volume over 1 s and other secondary outcomes were also small and clinically unimportant. Conclusion: The results of this study suggest that steroid-naïve patients with symptoms suggestive of asthma and an FeNO ≤ 27 ppb are unlikely to benefit from initiating treatment with an ICS over 3 months. However, further research is recommended to confirm these findings before withholding ICS treatment. 1

Citation

Shaw, D., Martin, M. J., Sutherland, L., Shaw, K., Parrish, C., Singleton, N., …Harrison, T. (2021). A low exhaled nitric oxide level excludes a short-term benefit from inhaled corticosteroids in suspected asthma: A randomized placebo-controlled trial. Respirology, 26(7), 666-672. https://doi.org/10.1111/resp.14055

• Journal Article Type: Article
• Acceptance Date: Feb 23, 2021
• Online Publication Date: May 3, 2021
• Publication Date: 2021-07
• Deposit Date: Apr 14, 2021
• Publicly Available Date: May 3, 2021
• Journal: Respirology
• Print ISSN: 1323-7799
• Electronic ISSN: 1440-1843
• Publisher: Wiley
• Peer Reviewed: Peer Reviewed
• Volume: 26
• Issue: 7
• Pages: 666-672
• DOI: https://doi.org/10.1111/resp.14055
• Public URL: https://nottingham-repository.worktribe.com/output/5464761
• Publisher URL: https://onlinelibrary.wiley.com/doi/10.1111/resp.14055