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@article{Heaney:2021:10.1016/S2213-2600(20)30397-0,
author = {Heaney, LG and Busby, J and Hanratty, CE and Djukanovic, R and Woodcock, A and Walker, SM and Hardman, TC and Arron, JR and Choy, DF and Bradding, P and Brightling, CE and Chaudhuri, R and Cowan, DC and Mansur, AH and Fowler, SJ and Niven, RM and Howarth, PH and Lordan, JL and Menzies-Gow, A and Harrison, TW and Robinson, DS and Holweg, CTJ and Matthews, JG and Pavord, ID and investigators, for the MRC Refractory Asthma Stratification Programme},
doi = {10.1016/S2213-2600(20)30397-0},
journal = {The Lancet Respiratory Medicine},
pages = {57--68},
title = {Composite type-2 biomarker strategy versus a symptom-risk-based algorithm to adjust corticosteroid dose in patients with severe asthma: a multicentre, single-blind, parallel group, randomised controlled trial},
url = {http://dx.doi.org/10.1016/S2213-2600(20)30397-0},
volume = {9},
year = {2021}
}

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TY  - JOUR
AB  - BACKGROUND: Asthma treatment guidelines recommend increasing corticosteroid dose to control symptoms and reduce exacerbations. This approach is potentially flawed because symptomatic asthma can occur without corticosteroid responsive type-2 (T2)-driven eosinophilic inflammation, and inappropriately high-dose corticosteroid treatment might have little therapeutic benefit with increased risk of side-effects. We compared a biomarker strategy to adjust corticosteroid dose using a composite score of T2 biomarkers (fractional exhaled nitric oxide [FENO], blood eosinophils, and serum periostin) with a standardised symptom-risk-based algorithm (control). METHODS: We did a single-blind, parallel group, randomised controlled trial in adults (18-80 years of age) with severe asthma (at treatment steps 4 and 5 of the Global Initiative for Asthma) and FENO of less than 45 parts per billion at 12 specialist severe asthma centres across England, Scotland, and Northern Ireland. Patients were randomly assigned (4:1) to either the biomarker strategy group or the control group by an online electronic case-report form, in blocks of ten, stratified by asthma control and use of rescue systemic steroids in the previous year. Patients were masked to study group allocation throughout the entirety of the study. Patients attended clinic every 8 weeks, with treatment adjustment following automated treatment-group-specific algorithms: those in the biomarker strategy group received a default advisory to maintain treatment and those in the control group had their treatment adjusted according to the steps indicated by the trial algorithm. The primary outcome was the proportion of patients with corticosteroid dose reduction at week 48, in the intention-to-treat (ITT) population. Secondary outcomes were inhaled corticosteroid (ICS) dose at the end of the study; cumulative dose of ICS during the study; proportion of patients on maintenance oral corticosteroids (OCS) at study end; rate of protocol-defi
AU  - Heaney,LG
AU  - Busby,J
AU  - Hanratty,CE
AU  - Djukanovic,R
AU  - Woodcock,A
AU  - Walker,SM
AU  - Hardman,TC
AU  - Arron,JR
AU  - Choy,DF
AU  - Bradding,P
AU  - Brightling,CE
AU  - Chaudhuri,R
AU  - Cowan,DC
AU  - Mansur,AH
AU  - Fowler,SJ
AU  - Niven,RM
AU  - Howarth,PH
AU  - Lordan,JL
AU  - Menzies-Gow,A
AU  - Harrison,TW
AU  - Robinson,DS
AU  - Holweg,CTJ
AU  - Matthews,JG
AU  - Pavord,ID
AU  - investigators,for the MRC Refractory Asthma Stratification Programme
DO  - 10.1016/S2213-2600(20)30397-0
EP  - 68
PY  - 2021///
SN  - 2213-2600
SP  - 57
TI  - Composite type-2 biomarker strategy versus a symptom-risk-based algorithm to adjust corticosteroid dose in patients with severe asthma: a multicentre, single-blind, parallel group, randomised controlled trial
T2  - The Lancet Respiratory Medicine
UR  - http://dx.doi.org/10.1016/S2213-2600(20)30397-0
UR  - https://www.ncbi.nlm.nih.gov/pubmed/32916135
UR  - https://www.sciencedirect.com/science/article/pii/S2213260020303970?via%3Dihub
UR  - http://hdl.handle.net/10044/1/82763
VL  - 9
ER  -

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