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Depts of 1 Clinical Biostatistics and 3 Clinical Research, Merck Research Laboratories, Rahway, NJ, USA. 2 Respiratory, Cell and Molecular Biology Research Division, School of Medicine, University of Southampton, Southampton, UK
CORRESPONDENCE: T. Reiss, Merck Research Laboratories, Pulmonary-Immunology, Mail code RY34B-328, Rahway, NJ 07065, USA. Fax: 1 7325947830. E-mail: theodore_reiss@merck.com
Keywords: asthma, montelukast, predictability of response, variability of asthma
Received: November 29, 2001
Accepted June 20, 2002
This study was supported by a grant from the Merck Research Laboratories.
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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