The Predicting Response to Inhaled Corticosteroid Efficacy (PRICE) trial

Richard J. Martin, Stanley J. Szefler, Tonya King, Monica Kraft, Homer A. Boushey, Vernon Chinchilli, Timothy Craig, Emily A. DiMango, Aaron Deykin, John V. Fahy, Elliot Israel, Stephen C. Lazarus, Robert F. Lemanske, Frank T. Leone, Gene R. Pesola, Stephen P. Peters, Christine A. Sorkness, Lisa A. Szwejbka, Michael E. Wechsler

Research output: Contribution to journalArticle

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Abstract

Background: 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. Objective: 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). Methods: 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 FEV1 and methacholine PC20. After this, an additional 4-month trial evaluated asthma control. Results: 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), FEV1/forced vital capacity (r = -0.75; P < .001), and FEV1 % predicted (r = -0.71; P < .001). Dividing the subjects in the short-term inhaled steroid trial into responders (>5% FEV1 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). Conclusion: The short-term response to inhaled corticosteroids with regard to FEV1 improvement predicts long-term asthma control. Clinical implications: 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.

Original languageEnglish (US)
Pages (from-to)73-80
Number of pages8
JournalJournal of Allergy and Clinical Immunology
Volume119
Issue number1
DOIs
StatePublished - Jan 1 2007

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Adrenal Cortex Hormones
Asthma
Steroids
Biomarkers
Methacholine Chloride
Albuterol
Multicenter Studies
Anti-Inflammatory Agents
Placebos
Guidelines
Lung

All Science Journal Classification (ASJC) codes

  • Immunology and Allergy
  • Immunology

Cite this

Martin, Richard J. ; Szefler, Stanley J. ; King, Tonya ; Kraft, Monica ; Boushey, Homer A. ; Chinchilli, Vernon ; Craig, Timothy ; 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. / The Predicting Response to Inhaled Corticosteroid Efficacy (PRICE) trial. In: Journal of Allergy and Clinical Immunology. 2007 ; Vol. 119, No. 1. pp. 73-80.
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abstract = "Background: 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. Objective: 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). Methods: 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 FEV1 and methacholine PC20. After this, an additional 4-month trial evaluated asthma control. Results: 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), FEV1/forced vital capacity (r = -0.75; P < .001), and FEV1 {\%} predicted (r = -0.71; P < .001). Dividing the subjects in the short-term inhaled steroid trial into responders (>5{\%} FEV1 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). Conclusion: The short-term response to inhaled corticosteroids with regard to FEV1 improvement predicts long-term asthma control. Clinical implications: 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.",
author = "Martin, {Richard J.} and Szefler, {Stanley J.} and Tonya King and Monica Kraft and Boushey, {Homer A.} and Vernon Chinchilli and Timothy Craig and DiMango, {Emily A.} and Aaron Deykin and Fahy, {John V.} and Elliot Israel and Lazarus, {Stephen C.} and Lemanske, {Robert F.} and Leone, {Frank T.} and Pesola, {Gene R.} and Peters, {Stephen P.} and Sorkness, {Christine A.} and Szwejbka, {Lisa A.} and Wechsler, {Michael E.}",
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Martin, RJ, Szefler, SJ, King, T, Kraft, M, Boushey, HA, Chinchilli, V, Craig, T, DiMango, EA, Deykin, A, Fahy, JV, Israel, E, Lazarus, SC, Lemanske, RF, Leone, FT, Pesola, GR, Peters, SP, Sorkness, CA, Szwejbka, LA & Wechsler, ME 2007, 'The Predicting Response to Inhaled Corticosteroid Efficacy (PRICE) trial', Journal of Allergy and Clinical Immunology, vol. 119, no. 1, pp. 73-80. https://doi.org/10.1016/j.jaci.2006.10.035

The Predicting Response to Inhaled Corticosteroid Efficacy (PRICE) trial. / Martin, Richard J.; Szefler, Stanley J.; King, Tonya; Kraft, Monica; Boushey, Homer A.; Chinchilli, Vernon; Craig, Timothy; 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.

In: Journal of Allergy and Clinical Immunology, Vol. 119, No. 1, 01.01.2007, p. 73-80.

Research output: Contribution to journalArticle

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T1 - The Predicting Response to Inhaled Corticosteroid Efficacy (PRICE) trial

AU - Martin, Richard J.

AU - Szefler, Stanley J.

AU - King, Tonya

AU - Kraft, Monica

AU - Boushey, Homer A.

AU - Chinchilli, Vernon

AU - Craig, Timothy

AU - DiMango, Emily A.

AU - Deykin, Aaron

AU - Fahy, John V.

AU - Israel, Elliot

AU - Lazarus, Stephen C.

AU - Lemanske, Robert F.

AU - Leone, Frank T.

AU - Pesola, Gene R.

AU - Peters, Stephen P.

AU - Sorkness, Christine A.

AU - Szwejbka, Lisa A.

AU - Wechsler, Michael E.

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Y1 - 2007/1/1

N2 - Background: 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. Objective: 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). Methods: 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 FEV1 and methacholine PC20. After this, an additional 4-month trial evaluated asthma control. Results: 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), FEV1/forced vital capacity (r = -0.75; P < .001), and FEV1 % predicted (r = -0.71; P < .001). Dividing the subjects in the short-term inhaled steroid trial into responders (>5% FEV1 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). Conclusion: The short-term response to inhaled corticosteroids with regard to FEV1 improvement predicts long-term asthma control. Clinical implications: 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.

AB - Background: 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. Objective: 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). Methods: 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 FEV1 and methacholine PC20. After this, an additional 4-month trial evaluated asthma control. Results: 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), FEV1/forced vital capacity (r = -0.75; P < .001), and FEV1 % predicted (r = -0.71; P < .001). Dividing the subjects in the short-term inhaled steroid trial into responders (>5% FEV1 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). Conclusion: The short-term response to inhaled corticosteroids with regard to FEV1 improvement predicts long-term asthma control. Clinical implications: 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.

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