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Dissociation between clinical trial inclusion and exclusion criteria for trials in severe asthma and the reality of the patient population

Dissociation between clinical trial inclusion and exclusion criteria for trials in severe asthma and the reality of the patient population
Dissociation between clinical trial inclusion and exclusion criteria for trials in severe asthma and the reality of the patient population
Rationale: Clinical trials of new biologics in adults with severe asthma require standardised entry criteria. These commonly include a history of disease exacerbation, current poor control, impaired lung function and evidence of bronchodilator reversibility. Cigarette smoking history and oral steroid therapy are often exclusion criteria. With therapies targeting Th2 inflammation there are also requirements for evidence of eosinophilic disease. To determine the proportion of patients eligible for such studies these criteria were evaluated in the Wessex Severe Asthma cohort (WSAC).

Methods: Four hundred and thirty four patients with asthma managed at steps 4 (65.9%) and 5 (34.1%) of the guidelines with a history of at least one severe exacerbation in the last year underwent detailed characterization.

Results: At this time point 87.8% had an asthma control questionnaire (ACQ)6 of ≥1.5, 55.1% had a pre-bronchodilator FEV1 between 40-80% predicted, 40.8% had ≥12% reversibility with nebulized salbutamol (2.5mg) and 24.2% were either ex-smokers with ≥10 pack year history (18.4%) or current smokers (5.8%). Only 10.6% fulfilled all these inclusion and exclusion criteria and the addition of a further eosinophilic filter (peripheral blood eosinophils ≥0.3 x 109/L or FeNO ≥ 50ppb or sputum eosinophils ≥2%) reduced this figure to 6.5% of the starting population.

Conclusion: Standard asthma inclusion and exclusion criteria used in trials of new therapies in severe asthma exclude the vast majority of patients with this spectrum of disease and do not address the unmet need.

Funding: WSAC was funded by the Medical Research Council UK.
0903-1936
Brown, Tom
fdd42359-a39d-4f22-b48d-015d9b94ec76
Rupani, Hitasha
cbc7068a-4279-4c8e-b83f-353210711062
Barber, Clair
ff31b460-34c3-466c-90e4-f70b3e954c82
Elliott, Scott P
f3234b8e-63df-45b3-a832-26b9a1acaf7f
Gove, Kerry
6493b359-21cd-4068-88f4-a6e684f73316
Lau, Laurie
2af8045d-6162-4939-aba7-28dd2f60f6a8
Hewitt, Lorraine
c4086add-4028-4002-b418-8766a1be0610
Ray, Emma
22094e4a-5948-4e20-b64d-72a91fdaac5c
Marouzet, Lisa
6634a7d0-1aa2-41ae-be5f-b692f0016eee
Kerley, Sumita
2663952c-185c-4cc8-b8de-11a14bbfe36f
Kurukulaaratchy, Ramesh
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Grainge, Christopher
5089f70e-97d2-43c0-934c-9807b651c9e9
Djukanovic, Ratko
d9a45ee7-6a80-4d84-a0ed-10962660a98d
Chauhan, Anoop
4f606144-8948-4f82-8cb1-e57e7a05a8ed
Howarth, Peter
ff19c8c4-86b0-4a88-8f76-b3d87f142a21
Brown, Tom
fdd42359-a39d-4f22-b48d-015d9b94ec76
Rupani, Hitasha
cbc7068a-4279-4c8e-b83f-353210711062
Barber, Clair
ff31b460-34c3-466c-90e4-f70b3e954c82
Elliott, Scott P
f3234b8e-63df-45b3-a832-26b9a1acaf7f
Gove, Kerry
6493b359-21cd-4068-88f4-a6e684f73316
Lau, Laurie
2af8045d-6162-4939-aba7-28dd2f60f6a8
Hewitt, Lorraine
c4086add-4028-4002-b418-8766a1be0610
Ray, Emma
22094e4a-5948-4e20-b64d-72a91fdaac5c
Marouzet, Lisa
6634a7d0-1aa2-41ae-be5f-b692f0016eee
Kerley, Sumita
2663952c-185c-4cc8-b8de-11a14bbfe36f
Kurukulaaratchy, Ramesh
9c7b8105-2892-49f2-8775-54d4961e3e74
Grainge, Christopher
5089f70e-97d2-43c0-934c-9807b651c9e9
Djukanovic, Ratko
d9a45ee7-6a80-4d84-a0ed-10962660a98d
Chauhan, Anoop
4f606144-8948-4f82-8cb1-e57e7a05a8ed
Howarth, Peter
ff19c8c4-86b0-4a88-8f76-b3d87f142a21

Brown, Tom, Rupani, Hitasha, Barber, Clair, Elliott, Scott P, Gove, Kerry, Lau, Laurie, Hewitt, Lorraine, Ray, Emma, Marouzet, Lisa, Kerley, Sumita, Kurukulaaratchy, Ramesh, Grainge, Christopher, Djukanovic, Ratko, Chauhan, Anoop and Howarth, Peter (2014) Dissociation between clinical trial inclusion and exclusion criteria for trials in severe asthma and the reality of the patient population. European Respiratory Journal, 44 (Suppl 58).

Record type: Meeting abstract

Abstract

Rationale: Clinical trials of new biologics in adults with severe asthma require standardised entry criteria. These commonly include a history of disease exacerbation, current poor control, impaired lung function and evidence of bronchodilator reversibility. Cigarette smoking history and oral steroid therapy are often exclusion criteria. With therapies targeting Th2 inflammation there are also requirements for evidence of eosinophilic disease. To determine the proportion of patients eligible for such studies these criteria were evaluated in the Wessex Severe Asthma cohort (WSAC).

Methods: Four hundred and thirty four patients with asthma managed at steps 4 (65.9%) and 5 (34.1%) of the guidelines with a history of at least one severe exacerbation in the last year underwent detailed characterization.

Results: At this time point 87.8% had an asthma control questionnaire (ACQ)6 of ≥1.5, 55.1% had a pre-bronchodilator FEV1 between 40-80% predicted, 40.8% had ≥12% reversibility with nebulized salbutamol (2.5mg) and 24.2% were either ex-smokers with ≥10 pack year history (18.4%) or current smokers (5.8%). Only 10.6% fulfilled all these inclusion and exclusion criteria and the addition of a further eosinophilic filter (peripheral blood eosinophils ≥0.3 x 109/L or FeNO ≥ 50ppb or sputum eosinophils ≥2%) reduced this figure to 6.5% of the starting population.

Conclusion: Standard asthma inclusion and exclusion criteria used in trials of new therapies in severe asthma exclude the vast majority of patients with this spectrum of disease and do not address the unmet need.

Funding: WSAC was funded by the Medical Research Council UK.

Full text not available from this repository.

More information

Published date: September 2014
Venue - Dates: Munich European Respiratory Society Congress, 2014-09-06 - 2014-09-10

Identifiers

Local EPrints ID: 422525
URI: https://eprints.soton.ac.uk/id/eprint/422525
ISSN: 0903-1936
PURE UUID: 52256c03-4e08-4e88-8928-822399fe1d63
ORCID for Clair Barber: ORCID iD orcid.org/0000-0001-5335-5129
ORCID for Ratko Djukanovic: ORCID iD orcid.org/0000-0001-6039-5612

Catalogue record

Date deposited: 25 Jul 2018 16:30
Last modified: 14 Mar 2019 01:55

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