Lessons learned from variation in response to therapy in clinical trials - 13/08/11

Doi : 10.1016/j.jaci.2009.10.026

Stanley J. Szefler, MD ^a,^⁎ , Richard J. Martin, MD ^b
^a Divisions of Pediatric Clinical Pharmacology and Allergy and Immunology, Department of Pediatrics, National Jewish Health, Denver, Colo
^b Department of Medicine, National Jewish Health, Denver, Colo

Reprint requests: Stanley J. Szefler, MD, National Jewish Health, 1400 Jackson St, Room J304 Molly Blank Building, Denver, CO 80206.

Abstract

In the past, we viewed lack of response to asthma medications as a rare event. Based on recent studies, we now expect significant variation in treatment response for all asthma medications. However, little information is available about methods to predict favorable treatment response. Research conducted in the National Heart, Lung, and Blood Institute’s Asthma Clinical Research Network and Childhood Asthma Research and Education Network verified this variability in response to several long-term control medications, specifically inhaled corticosteroids and leukotriene receptor antagonists, in adults and children with mild-to-moderate persistent asthma. The networks also identified potential methods to use patients’ characteristics, such as age and allergic status, and biomarkers, such as bronchodilator response, exhaled nitric oxide, and urinary leukotrienes, to help predict response to inhaled corticosteroids and leukotriene receptor antagonists and to determine which of the 2 treatments might be more effective in individual patients. This information now assists the clinician in personalizing asthma treatment at the time of initiating long-term control therapy.

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Key words : Asthma, treatment response, inhaled corticosteroids, leukotriene receptor antagonists, leukotriene modifiers, β-adrenergic agonists

Abbreviations used : ACD, ACRN, BDP, CARE, CLIC, eNO, FP, ICS, LTRA, MDI, MICE, NHLBI, PACT, PEAK, PRICE

Plan

Measuring response in a clinical trial: The components of treatment response

Analyzing variability in treatment response

Identifying predictors of response

Clinical implications of variability in treatment response

	Series editors: Donald Y. M. Leung, MD, PhD, and Dennis K. Ledford, MD
	Supported in part by Public Health Services research grants HR-16048, HL64288, HL 51834, AI-25496, HL081335, HL075416, and HL087811; the Colorado CTSA grant 1 UL1 RR025780 from the National Institutes of Health and National Center for Research Resources; and the Colorado Cancer, Cardiovascular, and Pulmonary Disease Program.