The Asthma Disease Activity Score: A discriminating, responsive measure predicts future asthma attacks - 31/10/12
, Nancy Liu, PhD c, Amarjot Kaur, PhD c, Mani Lakshminarayanan, PhD c, Yijie Zhou, PhD c, Linda Nelsen, MHS d, Davis F. Gates, PhD c, Wen-Ling Kuo, PhD c, Steven S. Smugar, MD e, Theodore F. Reiss, MD a, 
, Neil Barnes f, Anne Fuhlbrigge, MD, MPH g, Henry Milgrom, MD h, Michael Schatz, MD, MS i, Barbara Knorr, MD aCorresponding author: Steven Greenberg, MD, Merck Sharp & Dohme, 2000 Galloping Hill Rd, Kenilworth, NJ 07033.Abstract |
Background |
Classifying asthma severity or activity has evolved, but there are no published weighted composite measures of asthma disease activity that account for the relative importance of the many individual clinical variables that are widely used.
Objectives |
We sought to develop a weighted and responsive measure of asthma disease activity.
Methods |
Discriminant and multiple regression analyses based on 2 previously conducted clinical trials were used to develop the Asthma Disease Activity Score (ADAS-6).
Results |
The ADAS-6 demonstrated content validity because its components assess different manifestations of asthma: FEV1 (percent predicted), Asthma Quality of Life Questionnaire–Symptom domain, rescue β-agonist use, nocturnal awakenings, peak expiratory flow diurnal variability, and rescue β-agonist use diurnal variability. The ADAS-6 demonstrated cross-sectional and longitudinal validity. It was discriminating: it distinguished levels of disease activity and response to different treatment intensities (P < .0001). Similar results were obtained with an independent clinical trial. The ADAS-6 was highly responsive to treatment effects, with a standardized effect size exceeding that of other widely used outcome measures. Using ADAS-6 as the primary end point in the montelukast pivotal trials would have significantly reduced the sample size needed to detect a comparable change in outcome. Furthermore, increments in the ADAS-6 predicted the risk of future asthma attacks. A simplified Asthma Disease Activity Score 4-variable version (ADAS-4) demonstrated similar measurement properties.
Conclusions |
The ADAS-6 and ADAS-4 are novel, weighted, and responsive measures of asthma disease activity. Use of these measures in clinical trials might better separate treatment effects, predict future asthma attacks, and substantially reduce sample size.
Le texte complet de cet article est disponible en PDF.Key words : Asthma, activity, exacerbations, asthma-specific quality of life, regression, validity
Abbreviations used : ACQ, ADAS-6, ADAS-4, AQLQ, DA, DAS, DSS, MR, PEF, RA
Plan
| Supported by Merck Sharp & Dohme Corp, a subsidiary of Merck & Co, Inc. |
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| Disclosure of potential conflict of interest: S. Greenberg, L. Nelsen, and S. S. Smugar are employed by and own stock/stock options in Merck. A. Kaur, M. Lakshminarayanan, Y. Zhou, D. F. Gates, W.-L. Kuo, T. F. Reiss, and B. Knorr and are employed by Merck. N. Barnes has received one or more consulting fees or honoraria from Merck; has consultancy arrangements with GlaxoSmithKline, Mundipharma, Napp Laboratories, and Novartis; has received one or more payments for lecturing from or is on the speakers’ bureau for GlaxoSmithKline, Novartis, Chiesi, and Nycomed/Takeda; and has received one or more payments for travel/accommodations/meeting expenses from Boehringer Ingelheim and Nycomed/Takeda. A. Fuhlbrigge has been supported by one or more grants from and has received support for travel from the National Heart, Lung, and Blood Institute (NHLBI); is a board member for Merck; has consultancy arrangements with Merck, GlaxoSmithKline, ICON Medical Imaging, Sunovion, the Lovelace Respiratory Research Institute, and Dmagi; and has received one or more grants from or has one or more grants pending with the NHLBI and the Agency for Healthcare Research and Quality (AHRQ). M. Schatz has received one or more consulting fees or honoraria from Merck; has consultancy arrangements with GlaxoSmithKline, Amgen, and Boston Scientific; and has received one or more grants from or has one or more grants pending with GlaxoSmithKline, Merck, Aerocrine, Genentech, and MedImmune. The rest of the authors declare that they have no relevant conflicts of interest. |
Vol 130 - N° 5
P. 1071 - novembre 2012 Retour au numéro
Article précédent
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