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The asthma disease activity score: a discriminating, responsive measure predicts future asthma attacks
Steven Greenberg1, Nancy Liu, Amarjot Kaur
1Clinical Research, Merck Sharp & Dohme Corp, Whitehouse Station, NJ, USA. steven_greenberg@merck.com
The Journal of Allergy and Clinical Immunology
|October 6, 2012
Summary
A new Asthma Disease Activity Score (ADAS-6) and a simplified ADAS-4 were developed. These weighted measures accurately assess asthma activity, predict attacks, and can reduce clinical trial sample sizes.
Area of Science:
- Pulmonary Medicine
- Clinical Trials
- Biostatistics
Background:
- Current asthma severity classification lacks weighted composite measures.
- Existing methods do not fully account for the relative importance of individual clinical variables.
Purpose of the Study:
- To develop a novel, weighted, and responsive measure of asthma disease activity.
- To create a tool that better reflects the multifaceted nature of asthma.
Main Methods:
- Developed the Asthma Disease Activity Score (ADAS-6) using discriminant and regression analyses.
- Utilized data from two prior clinical trials for score development.
- Validated the score using an independent clinical trial.
Main Results:
- The ADAS-6 demonstrated content, cross-sectional, and longitudinal validity.
- It accurately discriminated disease activity levels and treatment responses (P < .0001).
- The ADAS-6 showed high responsiveness to treatment, exceeding other measures and potentially reducing sample size needs.
Conclusions:
- The ADAS-6 and a 4-variable version (ADAS-4) are validated, weighted measures of asthma disease activity.
- These scores can improve treatment effect separation and predict future asthma attacks.
- Implementing these measures may significantly reduce sample sizes in clinical trials.
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