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1. A randomised pragmatic trial of corticosteroid optimization in severe asthma using a composite biomarker algorithm to adjust corticosteroid dose versus standard care: study protocol for a randomised trial

Author

Catherine E. Hanratty, John G. Matthews, Joseph R. Arron, David F. Choy, Ian D. Pavord, P. Bradding, Christopher E. Brightling, Rekha Chaudhuri, Douglas C. Cowan, Ratko Djukanovic, Nicola Gallagher, Stephen J. Fowler, Tim C. Hardman, Tim Harrison, Cécile T. Holweg, Peter H. Howarth, James Lordan, Adel H. Mansur, Andrew Menzies-Gow, Sofia Mosesova, Robert M. Niven, Douglas S. Robinson, Dominick E. Shaw, Samantha Walker, Ashley Woodcock, Liam G. Heaney, and on behalf of the RASP-UK (Refractory Asthma Stratification Programme) Consortium

Subjects
Asthma, Biomarkers, Corticosteroids, Steroid titration, T2-low, Personalized medicine, Medicine (General), R5-920
Abstract

Abstract Background Patients with difficult-to-control asthma consume 50–60% of healthcare costs attributed to asthma and cost approximately five-times more than patients with mild stable disease. Recent evidence demonstrates that not all patients with asthma have a typical type 2 (T2)-driven eosinophilic inflammation. These asthmatics have been called ‘T2-low asthma’ and have a minimal response to corticosteroid therapy. Adjustment of corticosteroid treatment using sputum eosinophil counts from induced sputum has demonstrated reduced severe exacerbation rates and optimized corticosteroid dose. However, it has been challenging to move induced sputum into the clinical setting. There is therefore a need to examine novel algorithms to target appropriate levels of corticosteroid treatment in difficult asthma, particularly in T2-low asthmatics. This study examines whether a composite non-invasive biomarker algorithm predicts exacerbation risk in patients with asthma on high-dose inhaled corticosteroids (ICS) (± long-acting beta agonist) treatment, and evaluates the utility of this composite score to facilitate personalized biomarker-specific titration of corticosteroid therapy. Methods/design Patients recruited to this pragmatic, multi-centre, single-blinded randomised controlled trial are randomly allocated into either a biomarker controlled treatment advisory algorithm or usual care group in a ratio of 4:1. The primary outcome measure is the proportion of patients with any reduction in ICS or oral corticosteroid dose from baseline to week 48. Secondary outcomes include the rate of protocol-defined severe exacerbations per patient per year, time to first severe exacerbation from randomisation, dose of inhaled steroid at the end of the study, cumulative dose of inhaled corticosteroid during the study, proportion of patients on oral corticosteroids at the end of the study, proportion of patients who decline to progress to oral corticosteroids despite composite biomarker score of 2, frequency of hospital admission for asthma, change in the 7-item Asthma Control Questionnaire (ACQ-7), Asthma Quality of Life Questionnaire (AQLQ), forced expiratory volume in 1 s (FEV1), exhaled nitric oxide, blood eosinophil count, and periostin levels from baseline to week 48. Blood will also be taken for whole blood gene expression; serum, plasma, and urine will be stored for validation of additional biomarkers. Discussion Multi-centre trials present numerous logistical issues that have been addressed to ensure minimal bias and robustness of study conduct. Trial registration ClinicalTrials.gov, NCT02717689 . Registered on 16 March 2016.

Published
2018
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2. A randomised pragmatic trial of corticosteroid optimization in severe asthma using a composite biomarker algorithm to adjust corticosteroid dose versus standard care: study protocol for a randomised trial.

Author

Hanratty, Catherine E., Matthews, John G., Arron, Joseph R., Choy, David F., Pavord, Ian D., Bradding, P., Brightling, Christopher E., Chaudhuri, Rekha, Cowan, Douglas C., Djukanovic, Ratko, Gallagher, Nicola, Fowler, Stephen J., Hardman, Tim C., Harrison, Tim, Holweg, Cécile T., Howarth, Peter H., Lordan, James, Mansur, Adel H., Menzies-Gow, Andrew, and Mosesova, Sofia

Subjects
*CORTICOSTEROIDS, *ASTHMA, *INFLAMMATION, *STEROIDS, *INDIVIDUALIZED medicine, *BIOLOGICAL tags
Abstract

Background: Patients with difficult-to-control asthma consume 50-60% of healthcare costs attributed to asthma and cost approximately five-times more than patients with mild stable disease. Recent evidence demonstrates that not all patients with asthma have a typical type 2 (T2)-driven eosinophilic inflammation. These asthmatics have been called 'T2-low asthma' and have a minimal response to corticosteroid therapy. Adjustment of corticosteroid treatment using sputum eosinophil counts from induced sputum has demonstrated reduced severe exacerbation rates and optimized corticosteroid dose. However, it has been challenging to move induced sputum into the clinical setting. There is therefore a need to examine novel algorithms to target appropriate levels of corticosteroid treatment in difficult asthma, particularly in T2-low asthmatics. This study examines whether a composite non-invasive biomarker algorithm predicts exacerbation risk in patients with asthma on high-dose inhaled corticosteroids (ICS) (± long-acting beta agonist) treatment, and evaluates the utility of this composite score to facilitate personalized biomarker-specific titration of corticosteroid therapy.Methods/design: Patients recruited to this pragmatic, multi-centre, single-blinded randomised controlled trial are randomly allocated into either a biomarker controlled treatment advisory algorithm or usual care group in a ratio of 4:1. The primary outcome measure is the proportion of patients with any reduction in ICS or oral corticosteroid dose from baseline to week 48. Secondary outcomes include the rate of protocol-defined severe exacerbations per patient per year, time to first severe exacerbation from randomisation, dose of inhaled steroid at the end of the study, cumulative dose of inhaled corticosteroid during the study, proportion of patients on oral corticosteroids at the end of the study, proportion of patients who decline to progress to oral corticosteroids despite composite biomarker score of 2, frequency of hospital admission for asthma, change in the 7-item Asthma Control Questionnaire (ACQ-7), Asthma Quality of Life Questionnaire (AQLQ), forced expiratory volume in 1 s (FEV1), exhaled nitric oxide, blood eosinophil count, and periostin levels from baseline to week 48. Blood will also be taken for whole blood gene expression; serum, plasma, and urine will be stored for validation of additional biomarkers.Discussion: Multi-centre trials present numerous logistical issues that have been addressed to ensure minimal bias and robustness of study conduct.Trial Registration: ClinicalTrials.gov, NCT02717689 . Registered on 16 March 2016. [ABSTRACT FROM AUTHOR]

Published
2018
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3. A randomised pragmatic trial of corticosteroid optimization in severe asthma using a composite biomarker algorithm to adjust corticosteroid dose versus standard care: study protocol for a randomised trial

Author

Hanratty, CE, Matthews, JG, Arron, JR, Choy, DF, Pavord, ID, Bradding, P, Brightling, CE, Chaudhuri, R, Cowan, DC, Djukanovic, R, Gallagher, N, Fowler, SJ, Hardman, TC, Harrison, T, Holweg, CT, Howarth, PH, Lordan, J, Mansur, AH, Menzies-Gow, A, Mosesova, S, Niven, RM, Robinson, DS, Shaw, DE, Walker, S, Woodcock, A, Heaney, LG, and RASP-UK Consortium

Subjects
Adult, Male, Time Factors, Adolescent, Clinical Decision-Making, Administration, Oral, 1102 Cardiovascular Medicine And Haematology, Young Adult, Study Protocol, Steroid titration, Adrenal Cortex Hormones, General & Internal Medicine, Forced Expiratory Volume, Administration, Inhalation, Pragmatic Clinical Trials as Topic, Humans, Multicenter Studies as Topic, Corticosteroids, Drug Dosage Calculations, Single-Blind Method, Lung, Aged, Aged, 80 and over, lcsh:R5-920, RASP-UK (Refractory Asthma Stratification Programme) Consortium, 1103 Clinical Sciences, Middle Aged, T2-low, Personalized medicine, Asthma, United Kingdom, Treatment Outcome, Cardiovascular System & Hematology, Female, lcsh:Medicine (General), Algorithms, Biomarkers
Abstract

Background Patients with difficult-to-control asthma consume 50–60% of healthcare costs attributed to asthma and cost approximately five-times more than patients with mild stable disease. Recent evidence demonstrates that not all patients with asthma have a typical type 2 (T2)-driven eosinophilic inflammation. These asthmatics have been called ‘T2-low asthma’ and have a minimal response to corticosteroid therapy. Adjustment of corticosteroid treatment using sputum eosinophil counts from induced sputum has demonstrated reduced severe exacerbation rates and optimized corticosteroid dose. However, it has been challenging to move induced sputum into the clinical setting. There is therefore a need to examine novel algorithms to target appropriate levels of corticosteroid treatment in difficult asthma, particularly in T2-low asthmatics. This study examines whether a composite non-invasive biomarker algorithm predicts exacerbation risk in patients with asthma on high-dose inhaled corticosteroids (ICS) (± long-acting beta agonist) treatment, and evaluates the utility of this composite score to facilitate personalized biomarker-specific titration of corticosteroid therapy. Methods/design Patients recruited to this pragmatic, multi-centre, single-blinded randomised controlled trial are randomly allocated into either a biomarker controlled treatment advisory algorithm or usual care group in a ratio of 4:1. The primary outcome measure is the proportion of patients with any reduction in ICS or oral corticosteroid dose from baseline to week 48. Secondary outcomes include the rate of protocol-defined severe exacerbations per patient per year, time to first severe exacerbation from randomisation, dose of inhaled steroid at the end of the study, cumulative dose of inhaled corticosteroid during the study, proportion of patients on oral corticosteroids at the end of the study, proportion of patients who decline to progress to oral corticosteroids despite composite biomarker score of 2, frequency of hospital admission for asthma, change in the 7-item Asthma Control Questionnaire (ACQ-7), Asthma Quality of Life Questionnaire (AQLQ), forced expiratory volume in 1 s (FEV1), exhaled nitric oxide, blood eosinophil count, and periostin levels from baseline to week 48. Blood will also be taken for whole blood gene expression; serum, plasma, and urine will be stored for validation of additional biomarkers. Discussion Multi-centre trials present numerous logistical issues that have been addressed to ensure minimal bias and robustness of study conduct. Trial registration ClinicalTrials.gov, NCT02717689. Registered on 16 March 2016. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-2384-7) contains supplementary material, which is available to authorized users.

Published
2017

4. A randomised pragmatic trial of corticosteroid optimization in severe asthma using a composite biomarker algorithm to adjust corticosteroid dose versus standard care: study protocol for a randomised trial

Author

Hanratty, Catherine E., Matthews, John G., Arron, Joseph R., Choy, David F., Pavord, Ian D., Bradding, P., Brightling, Christopher E., Chaudhuri, Rekha, Cowan, Douglas C., Djukanovic, Ratko, Gallagher, Nicola, Fowler, Stephen J., Hardman, Tim C., Harrison, Tim, Holweg, Cécile T., Howarth, Peter H., Lordan, James, Mansur, Adel H., Menzies-Gow, Andrew, Mosesova, Sofia, Niven, Robert M., Robinson, Douglas S., Shaw, Dominick E., Walker, Samantha, Woodcock, Ashley, Heaney, Liam G., Hanratty, Catherine E., Matthews, John G., Arron, Joseph R., Choy, David F., Pavord, Ian D., Bradding, P., Brightling, Christopher E., Chaudhuri, Rekha, Cowan, Douglas C., Djukanovic, Ratko, Gallagher, Nicola, Fowler, Stephen J., Hardman, Tim C., Harrison, Tim, Holweg, Cécile T., Howarth, Peter H., Lordan, James, Mansur, Adel H., Menzies-Gow, Andrew, Mosesova, Sofia, Niven, Robert M., Robinson, Douglas S., Shaw, Dominick E., Walker, Samantha, Woodcock, Ashley, and Heaney, Liam G.

Abstract

Background: Patients with difficult-to-control asthma consume 50–60% of healthcare costs attributed to asthma and cost approximately five-times more than patients with mild stable disease. Recent evidence demonstrates that not all patients with asthma have a typical type 2 (T2)-driven eosinophilic inflammation. These asthmatics have been called ‘T2-low asthma’ and have a minimal response to corticosteroid therapy. Adjustment of corticosteroid treatment using sputum eosinophil counts from induced sputum has demonstrated reduced severe exacerbation rates and optimized corticosteroid dose. However, it has been challenging to move induced sputum into the clinical setting. There is therefore a need to examine novel algorithms to target appropriate levels of corticosteroid treatment in difficult asthma, particularly in T2-low asthmatics. This study examines whether a composite non-invasive biomarker algorithm predicts exacerbation risk in patients with asthma on high-dose inhaled corticosteroids (ICS) (± long-acting beta agonist) treatment, and evaluates the utility of this composite score to facilitate personalized biomarker-specific titration of corticosteroid therapy. Methods/design: Patients recruited to this pragmatic, multi-centre, single-blinded randomised controlled trial are randomly allocated into either a biomarker controlled treatment advisory algorithm or usual care group in a ratio of 4:1. The primary outcome measure is the proportion of patients with any reduction in ICS or oral corticosteroid dose from baseline to week 48. Secondary outcomes include the rate of protocol-defined severe exacerbations per patient per year, time to first severe exacerbation from randomisation, dose of inhaled steroid at the end of the study, cumulative dose of inhaled corticosteroid during the study, proportion of patients on oral corticosteroids at the end of the study, proportion of patients who decline to progress to oral corticosteroids despite composite biomarker score of

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5. A randomised pragmatic trial of corticosteroid optimization in severe asthma using a composite biomarker algorithm to adjust corticosteroid dose versus standard care: study protocol for a randomised trial

Author

Hanratty, Catherine E., Matthews, John G., Arron, Joseph R., Choy, David F., Pavord, Ian D., Bradding, P., Brightling, Christopher E., Chaudhuri, Rekha, Cowan, Douglas C., Djukanovic, Ratko, Gallagher, Nicola, Fowler, Stephen J., Hardman, Tim C., Harrison, Tim, Holweg, Cécile T., Howarth, Peter H., Lordan, James, Mansur, Adel H., Menzies-Gow, Andrew, Mosesova, Sofia, Niven, Robert M., Robinson, Douglas S., Shaw, Dominick E., Walker, Samantha, Woodcock, Ashley, Heaney, Liam G., Hanratty, Catherine E., Matthews, John G., Arron, Joseph R., Choy, David F., Pavord, Ian D., Bradding, P., Brightling, Christopher E., Chaudhuri, Rekha, Cowan, Douglas C., Djukanovic, Ratko, Gallagher, Nicola, Fowler, Stephen J., Hardman, Tim C., Harrison, Tim, Holweg, Cécile T., Howarth, Peter H., Lordan, James, Mansur, Adel H., Menzies-Gow, Andrew, Mosesova, Sofia, Niven, Robert M., Robinson, Douglas S., Shaw, Dominick E., Walker, Samantha, Woodcock, Ashley, and Heaney, Liam G.

Abstract

Background: Patients with difficult-to-control asthma consume 50–60% of healthcare costs attributed to asthma and cost approximately five-times more than patients with mild stable disease. Recent evidence demonstrates that not all patients with asthma have a typical type 2 (T2)-driven eosinophilic inflammation. These asthmatics have been called ‘T2-low asthma’ and have a minimal response to corticosteroid therapy. Adjustment of corticosteroid treatment using sputum eosinophil counts from induced sputum has demonstrated reduced severe exacerbation rates and optimized corticosteroid dose. However, it has been challenging to move induced sputum into the clinical setting. There is therefore a need to examine novel algorithms to target appropriate levels of corticosteroid treatment in difficult asthma, particularly in T2-low asthmatics. This study examines whether a composite non-invasive biomarker algorithm predicts exacerbation risk in patients with asthma on high-dose inhaled corticosteroids (ICS) (± long-acting beta agonist) treatment, and evaluates the utility of this composite score to facilitate personalized biomarker-specific titration of corticosteroid therapy. Methods/design: Patients recruited to this pragmatic, multi-centre, single-blinded randomised controlled trial are randomly allocated into either a biomarker controlled treatment advisory algorithm or usual care group in a ratio of 4:1. The primary outcome measure is the proportion of patients with any reduction in ICS or oral corticosteroid dose from baseline to week 48. Secondary outcomes include the rate of protocol-defined severe exacerbations per patient per year, time to first severe exacerbation from randomisation, dose of inhaled steroid at the end of the study, cumulative dose of inhaled corticosteroid during the study, proportion of patients on oral corticosteroids at the end of the study, proportion of patients who decline to progress to oral corticosteroids despite composite biomarker score of

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6. A randomised pragmatic trial of corticosteroid optimization in severe asthma using a composite biomarker algorithm to adjust corticosteroid dose versus standard care: study protocol for a randomised trial

Author

Hanratty, Catherine E., Matthews, John G., Arron, Joseph R., Choy, David F., Pavord, Ian D., Bradding, P., Brightling, Christopher E., Chaudhuri, Rekha, Cowan, Douglas C., Djukanovic, Ratko, Gallagher, Nicola, Fowler, Stephen J., Hardman, Tim C., Harrison, Tim, Holweg, Cécile T., Howarth, Peter H., Lordan, James, Mansur, Adel H., Menzies-Gow, Andrew, Mosesova, Sofia, Niven, Robert M., Robinson, Douglas S., Shaw, Dominick E., Walker, Samantha, Woodcock, Ashley, Heaney, Liam G., Hanratty, Catherine E., Matthews, John G., Arron, Joseph R., Choy, David F., Pavord, Ian D., Bradding, P., Brightling, Christopher E., Chaudhuri, Rekha, Cowan, Douglas C., Djukanovic, Ratko, Gallagher, Nicola, Fowler, Stephen J., Hardman, Tim C., Harrison, Tim, Holweg, Cécile T., Howarth, Peter H., Lordan, James, Mansur, Adel H., Menzies-Gow, Andrew, Mosesova, Sofia, Niven, Robert M., Robinson, Douglas S., Shaw, Dominick E., Walker, Samantha, Woodcock, Ashley, and Heaney, Liam G.

Abstract

Background: Patients with difficult-to-control asthma consume 50–60% of healthcare costs attributed to asthma and cost approximately five-times more than patients with mild stable disease. Recent evidence demonstrates that not all patients with asthma have a typical type 2 (T2)-driven eosinophilic inflammation. These asthmatics have been called ‘T2-low asthma’ and have a minimal response to corticosteroid therapy. Adjustment of corticosteroid treatment using sputum eosinophil counts from induced sputum has demonstrated reduced severe exacerbation rates and optimized corticosteroid dose. However, it has been challenging to move induced sputum into the clinical setting. There is therefore a need to examine novel algorithms to target appropriate levels of corticosteroid treatment in difficult asthma, particularly in T2-low asthmatics. This study examines whether a composite non-invasive biomarker algorithm predicts exacerbation risk in patients with asthma on high-dose inhaled corticosteroids (ICS) (± long-acting beta agonist) treatment, and evaluates the utility of this composite score to facilitate personalized biomarker-specific titration of corticosteroid therapy. Methods/design: Patients recruited to this pragmatic, multi-centre, single-blinded randomised controlled trial are randomly allocated into either a biomarker controlled treatment advisory algorithm or usual care group in a ratio of 4:1. The primary outcome measure is the proportion of patients with any reduction in ICS or oral corticosteroid dose from baseline to week 48. Secondary outcomes include the rate of protocol-defined severe exacerbations per patient per year, time to first severe exacerbation from randomisation, dose of inhaled steroid at the end of the study, cumulative dose of inhaled corticosteroid during the study, proportion of patients on oral corticosteroids at the end of the study, proportion of patients who decline to progress to oral corticosteroids despite composite biomarker score of

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