The Predicting Response to Inhaled Corticosteroid Efficacy (PRICE) trial

• Published in: Journal of allergy and clinical immunology Vol. 119; no. 1; pp. 73 - 80
• Main Authors: Martin, Richard J., Szefler, Stanley J., King, Tonya S., Kraft, Monica, Boushey, Homer A., Chinchilli, Vernon M., Craig, Timothy J., DiMango, Emily A., Deykin, Aaron, Fahy, John V., Israel, Elliot, Lazarus, Stephen C., Lemanske, Robert F., Leone, Frank T., Pesola, Gene R., Peters, Stephen P., Sorkness, Christine A., Szwejbka, Lisa A., Wechsler, Michael E.
• Format: Journal Article
• Language: English
• Published: New York, NY Mosby, Inc 2007; Elsevier; Elsevier Limited
• Subjects: Adult; Allergy and Immunology; Anti-Asthmatic Agents - therapeutic use; Asthma; Asthma - drug therapy; Asthma - physiopathology; Beclomethasone - therapeutic use; Biological and medical sciences; Biomarkers; characteristics; Clinical Trials as Topic; Double-Blind Method; Female; Forced Expiratory Volume - drug effects; Fundamental and applied biological sciences. Psychology; Fundamental immunology; Humans; Immunopathology; Inhaled corticosteroids; Male; Medical research; Medical sciences; Middle Aged; predicting response; therapy; Treatment Outcome; ACRN; FeNO; characteristics; therapy; biomarkers; Inhaled corticosteroids; BHR; predicting response; ACQ; PEF; FVC; NHLBI; ICS; Forced vital capacity; Fraction of exhaled nitric oxide; Inhaled corticosteroid; National Heart, Lung, and Blood Institute; Asthma Control Questionnaire; Asthma Clinical Research Network; Bronchial hyperresponsiveness; Peak expiratory flow; Immunopathology; Corticosteroid; Treatment efficiency; Biological marker; Inhalation; Immunology; Treatment; Clinical trial
• ISSN: 0091-6749; 1097-6825
• DOI: 10.1016/j.jaci.2006.10.035

Although guidelines recommend anti-inflammatory therapy for persistent asthma, recent studies suggest that 25% to 35% of patients with asthma may not improve lung function with inhaled corticosteroids. To evaluate potential biomarkers of predicting short-term (6-week) response to inhaled corticosteroid with subsequent evaluation of responders and nonresponders to asthma control over a longer interval (16 additional weeks). Eighty-three subjects with asthma off steroid were enrolled in this multicenter study. Biomarkers and asthma characteristics were evaluated as predictors of inhaled corticosteroid response over a 6-week trial for changes in FEV 1 and methacholine PC 20. After this, an additional 4-month trial evaluated asthma control. Although multiple baseline predictors had significant correlations with improvements for short-term inhaled steroid success, the only strong correlations ( r ≥ ± 0.6) were albuterol reversibility ( r = 0.83; P < .001), FEV 1/forced vital capacity ( r = −0.75; P < .001), and FEV 1 % predicted ( r = −0.71; P < .001). Dividing the subjects in the short-term inhaled steroid trial into responders (>5% FEV 1 improvement) and nonresponders (≤5%) determined the longer-term need for steroids. For the nonresponders, asthma control remained unchanged whether inhaled corticosteroids were continued or were substituted with a placebo ( P = .99). The good short-term responders maintained asthma control longer-term only if maintained on inhaled steroids ( P = .007). The short-term response to inhaled corticosteroids with regard to FEV 1 improvement predicts long-term asthma control. The decision to use long-term inhaled steroids could be based on a short-term trial. Different therapeutic strategies would need to be established for nonresponders.