Variability and lack of predictive ability of asthma end-points in clinical trials
Variability and lack of predictive ability of asthma end-points in clinical trials
While a consensus definition of the clinical parameters important in asthma control exists, an adequate objective definition of a response to asthma treatment and parameters for prediction of that response remain undefined. Given that asthma is a complex biological disease and that different parameters may measure dissimilar aspects of the disease status, this study assessed the relationship among several end-points of asthma control, and attempted to select a combination of variables measured before (baseline characteristics) or early in asthma therapy which would be predictive of a long-term clinical response.
Data from two previously reported clinical studies which included montelukast, inhaled beclomethasone, and placebo in mild-to-moderate asthmatics (n=1,576) were analysed. The forced expiratory volume in one second (FEV1), daily symptoms score (DSS), ß-agonist use, and morning peak expiratory flow (PEFAM) were recorded during the baseline period and throughout the 12-week treatment period.
For the long-term response, as measured during the last 9 weeks of treatment, there was a large within-patient variability and no more than a moderate correlation between the changes in FEV1 and PEFAM; DSS and FEV1; and DSS and ß-agonist use. The overall predictive values for FEV1 and DSS were 70–80%.
The results showed that multiple measurements over a length of time are needed to establish a more complete profile of response, and that demographic and early treatment responses had a small but inadequate ability to predict future response. This study demonstrates the complex relationship among asthma end-points and the difficulty of reliably estimating long-term response using common, surrogate clinical markers of asthma control.
1102-1109
Zhang, J.
722d2564-f8ae-40f1-b1e1-07896b67a0d8
Yu, C.
e7b396fe-e570-4af4-a036-4bd4c13c43dd
Holgate, S.T.
2e7c17a9-6796-436e-8772-1fe6d2ac5edc
Reiss, T.F.
656fa8db-2cc0-4d40-a97a-601cccbbaf17
2002
Zhang, J.
722d2564-f8ae-40f1-b1e1-07896b67a0d8
Yu, C.
e7b396fe-e570-4af4-a036-4bd4c13c43dd
Holgate, S.T.
2e7c17a9-6796-436e-8772-1fe6d2ac5edc
Reiss, T.F.
656fa8db-2cc0-4d40-a97a-601cccbbaf17
Zhang, J., Yu, C., Holgate, S.T. and Reiss, T.F.
(2002)
Variability and lack of predictive ability of asthma end-points in clinical trials.
European Respiratory Journal, 20 (5), .
Abstract
While a consensus definition of the clinical parameters important in asthma control exists, an adequate objective definition of a response to asthma treatment and parameters for prediction of that response remain undefined. Given that asthma is a complex biological disease and that different parameters may measure dissimilar aspects of the disease status, this study assessed the relationship among several end-points of asthma control, and attempted to select a combination of variables measured before (baseline characteristics) or early in asthma therapy which would be predictive of a long-term clinical response.
Data from two previously reported clinical studies which included montelukast, inhaled beclomethasone, and placebo in mild-to-moderate asthmatics (n=1,576) were analysed. The forced expiratory volume in one second (FEV1), daily symptoms score (DSS), ß-agonist use, and morning peak expiratory flow (PEFAM) were recorded during the baseline period and throughout the 12-week treatment period.
For the long-term response, as measured during the last 9 weeks of treatment, there was a large within-patient variability and no more than a moderate correlation between the changes in FEV1 and PEFAM; DSS and FEV1; and DSS and ß-agonist use. The overall predictive values for FEV1 and DSS were 70–80%.
The results showed that multiple measurements over a length of time are needed to establish a more complete profile of response, and that demographic and early treatment responses had a small but inadequate ability to predict future response. This study demonstrates the complex relationship among asthma end-points and the difficulty of reliably estimating long-term response using common, surrogate clinical markers of asthma control.
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Published date: 2002
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Local EPrints ID: 27508
URI: http://eprints.soton.ac.uk/id/eprint/27508
ISSN: 0903-1936
PURE UUID: 914878c9-bf04-47dd-8704-6d24827e87cf
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Date deposited: 26 Apr 2006
Last modified: 08 Jan 2022 15:51
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Author:
J. Zhang
Author:
C. Yu
Author:
T.F. Reiss
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