The Journal of Allergy and Clinical Immunology
Volume 119, Issue 1 , Pages 73-80 , January 2007

The Predicting Response to Inhaled Corticosteroid Efficacy (PRICE) trial

  • Richard J. Martin, MD

      Affiliations

    • From National Jewish Medical and Research Center, Denver
    • Corresponding Author InformationReprint requests: Richard J. Martin, MD, National Jewish Medical and Research Center, 1400 Jackson Street, J206, Denver, CO 80206.
  • ,
  • Stanley J. Szefler, MD

      Affiliations

    • From National Jewish Medical and Research Center, Denver
  • ,
  • Tonya S. King, PhD

      Affiliations

    • Pennsylvania State University College of Medicine, Hershey
  • ,
  • Monica Kraft, MD

      Affiliations

    • From National Jewish Medical and Research Center, Denver
  • ,
  • Homer A. Boushey, MD

      Affiliations

    • University of California at San Francisco
  • ,
  • Vernon M. Chinchilli, PhD

      Affiliations

    • Pennsylvania State University College of Medicine, Hershey
  • ,
  • Timothy J. Craig, DO

      Affiliations

    • Pennsylvania State University College of Medicine, Hershey
  • ,
  • Emily A. DiMango, MD

      Affiliations

    • Harlem Hospital Center and Columbia University, New York
  • ,
  • Aaron Deykin, MD

      Affiliations

    • Brigham and Women's Hospital and Harvard Medical School, Boston
  • ,
  • John V. Fahy, MD

      Affiliations

    • University of California at San Francisco
  • ,
  • Elliot Israel, MD

      Affiliations

    • Brigham and Women's Hospital and Harvard Medical School, Boston
  • ,
  • Stephen C. Lazarus, MD

      Affiliations

    • University of California at San Francisco
  • ,
  • Robert F. Lemanske Jr., MD

      Affiliations

    • University of Wisconsin
  • ,
  • Frank T. Leone, MD

      Affiliations

    • Thomas Jefferson University, Philadelphia
  • ,
  • Gene R. Pesola, MD, MPH

      Affiliations

    • Harlem Hospital Center and Columbia University, New York
  • ,
  • Stephen P. Peters, MD, PhD

      Affiliations

    • Thomas Jefferson University, Philadelphia
  • ,
  • Christine A. Sorkness, PharmD

      Affiliations

    • University of Wisconsin
  • ,
  • Lisa A. Szwejbka, MSPH

      Affiliations

    • Pennsylvania State University College of Medicine, Hershey
  • ,
  • Michael E. Wechsler, MD

      Affiliations

    • Brigham and Women's Hospital and Harvard Medical School, Boston
  • ,
  • for the National Heart, Lung, and Blood Institute's Asthma Clinical Research Center

Received 6 July 2006 ,Revised 25 October 2006 ,Accepted 30 October 2006.

References 

  1. Barnes PJ, Pedersen S, Busse WW. Efficacy and safety of inhaled corticosteroids: new developments. Am J Respir Crit Care Med. 1998;157:S1–S53
  2. Busse WW. Inflammation in asthma: the cornerstone of the disease and target of therapy. J Allergy Clin Immunol. 1998;102:S17–S22
  3. National Asthma Education and Prevention Program . Guidelines for the diagnosis and management of asthma: Expert Panel Report 2. Publication #97-4051. Bethesda (MD): National Institutes of Health/National Heart, Lung, and Blood Institute; 1997;
  4. Global Initiative for Asthma . Global strategy for asthma management and prevention: NHLBI/NIH Workshop Report. Publication #95-3659. Bethesda (MD): National Institutes of Health/National Heart, Lung, and Blood Institute; 1995;
  5. Malmstrom K, Rodriguez-Gomez G, Guerra J, Villaran C, Pineiro A, Wei LX, et al. Oral montelukast, inhaled beclomethasone, and placebo for chronic asthma: a randomized, controlled trial. Montelukast/Beclomethasone Study Group. Ann Intern Med. 1999;130:487–495
  6. Kerrebijn KF, van Essen-Zandvliet EE, Neijens HJ. Effect of long-term treatment with inhaled corticosteroids and beta-agonists on the bronchial responsiveness in children with asthma. J Allergy Clin Immunol. 1987;79:653–659
  7. Szefler SJ, Martin RJ, King TS, Boushey HA, Cherniack RM, Chinchilli VM, et al. Significant variability in response to inhaled corticosteroids for persistent asthma. J Allergy Clin Immunol. 2002;109:410–418
  8. Bateman ED, Boushey HA, Bousquet J, Busse WW, Clark TJ, Pauwels RA, et al. Can guideline-defined asthma control be achieved? The Gaining Optimal Asthma ControL study. Am J Respir Crit Care Med. 2004;170:836–844
  9. Juniper EF, O'Byrne PM, Roberts JN. Measuring asthma control in group studies: do we need airway calibre and rescue beta2-agonist use?. Respir Med. 2001;95:319–323
  10. Drazen JM, Israel E, Boushey HA, Chinchilli VM, Fahy JV, Fish JE, et al. Comparison of regularly scheduled with as-needed use of albuterol in mild asthma. Asthma Clinical Research Network. N Engl J Med. 1996;335:841–847
  11. Lemanske RF, Sorkness CA, Mauger EA, Lazarus SC, Boushey HA, Fahy JV, et al. Inhaled corticosteroid reduction and elimination in patients with persistent asthma receiving salmeterol: a randomized controlled trial. JAMA. 2001;285:2594–2603
  12. Boushey HA, Sorkness CA, King TS, Sullivan SD, Fahy JV, Lazarus SC, et al. Daily versus as-needed corticosteroids for mild persistent asthma. N Engl J Med. 2005;352:1519–1528
  13. Noether G. Sample size determination for some common nonparametric tests. J Am Stat Assoc. 1987;82:645–647
  14. Little SA, Chalmers GW, MacLeod KJ, McSharry C, Thomson NC. Non-invasive markers of airway inflammation as predictors of oral steroid responsiveness in asthma. Thorax. 2000;55:232–234
  15. Smith AD, Cowan JO, Brassett KP, Filsell S, McLachlan C, Monti-Sheehan G, et al. Exhaled nitric oxide: a predictor of steroid response. Am J Respir Crit Care Med. 2005;172:453–459
  16. Pavord ID, Brightling CE, Woltmann G, Wardlaw AJ. Non-eosinophilic corticosteroid unresponsive asthma. Lancet. 1999;353:2213–2214
  17. Bacci E, Cianchetti S, Bartoli M, Dente FL, Di Franco A, Vagaggini B, et al. Low sputum eosinophils predict the lack of response to beclomethasone in symptomatic asthmatic patients. Chest. 2006;129:565–572
  18. Brightling CE. Sputum induction in asthma: a research technique or a clinical tool?. Chest. 2006;129:503–504
  19. Szefler SJ, Phillips BR, Martinez FD, Chinchilli VM, Lemanske RF, Strunk RC, et al. Characterization of within-subject responses to fluticasone and montelukast in childhood asthma. J Allergy Clin Immunol. 2005;115:233–242
  20. Deykin A, Lazarus SC, Fahy JV, Wechsler ME, Boushey HA, Chinchilli VM, et al. Sputum eosinophil counts predict asthma control after discontinuation of inhaled corticosteroids. J Allergy Clin Immunol. 2005;115:720–727
  21. Smith AD, Cowan JO, Brassett KP, Herbison GP, Taylor DR. Use of exhaled nitric oxide measurements to guide treatment in chronic asthma. N Engl J Med. 2005;352:2163–2173
  22. Green RH, Brightling CE, McKenna S, Hargadon B, Parker D, Bradding P, et al. Asthma exacerbations and sputum eosinophil counts: a randomised controlled trial. Lancet. 2002;360:1715–1721
  23. Szefler SJ, Boushey HA, Pearlman DS, Togias A, Liddle R, Furlong A, et al. Time to onset of effect of fluticasone propionate in patients with asthma. J Allergy Clin Immunol. 1999;103:780–788

 Supported by US National Institutes of Health (NIH)/National Heart, Lung, and Blood Institute (NHLBI)-HL04285, HL051810, HL051823, HL051831, HL051834, HL051843, HL051845, and HL056443.Disclosure of potential conflict of interest: R. J. Martin has consulting arrangements with Ivax, Merck, GlaxoSmithKline, Schering, Novartis, Genentech, Altana, and Sanofi-Aventis; has received grant support from GlaxoSmithKline and Altana; and is on the speakers' bureau for Ivax, Merck, Novartis, and Genentech. S. J. Szefler has consulting arrangements with AstraZeneca, GlaxoSmithKline, Aventis, Genentech, and Merck and has received grant support from the NIH, the NHLBI, the National Institute of Allergy and Infectious Diseases (NIAID), and Ross Pharmaceuticals. M. Kraft has consulting arrangements with Genentech, GlaxoSmithKline, Merck, Boehringer Ingelheim, Asthmatx, and TEVA; has received grant support from GlaxoSmithKline, Genentech, Altana, and Asthmatx; and is on the speakers' bureau for GlaxoSmithKline, Genentech, Merck, Schering, Sepraco, and Pfizer. H. A. Boushey has consulting arrangements with Watermark Research Protein Design Lab, Altana, and Sumitomo; has received grant support from GlaxoSmithKline; and has received honoraria from Merck, Novartis, Sanofi-Aventis, and Genentech. V. M. Chinchilli has received grant support from the Asthma Clinical Research Network, the NIH, and the Childhood Asthma Research and Education Network. T. J. Craig has consulting arrangements with Alcon, Johnson and Johnson, and TEVA; has received grant support from GlaxoSmithKline, Merck, Sanofi-Aventis, Boehringer Ingelheim, Dyax, ZLB, LEV, Pharming, and AstraZeneca; and is on the speakers' bureau for Merck, Pfizer, AstraZeneca, Boehringer Ingelheim, Dyax, ZLB, LEV, Pharming, and Sanofi-Aventis. E. A. DiMango has consulting arrangements with AstraZeneca and has received grant support from Novartis and Genentech. A. Deykin has consulting arrangements with Aerocrine; owns stock in Biogen Idec; is employed by Biogen Idec; has received grant support from Merck; and is on the speakers' bureau for Merck. J. V. Fahy has consulting arrangements with Arriva Pharmaceuticals, Abgenix, Oxagen, and Zymogenetics and has received grant support from the NHLBI, the California Tobacco Research Program, and the University of California, San Francisco Sandler Asthma Program. E. Israel has consulting arrangements with Asthmatx, Critical Therapeutics, Genentech, Merck, Novartis, Protein Design Lab, Schering Plough, and Wyeth Research; has received grant support from Asthmatx, Boehringer Ingelheim, Centocor, Genentech, GlaxoSmithKline, and Merck; and is on the speakers' bureau for Genentech and Merck. R. F. Lemanske, Jr, has consulting arrangements with Merck, GlaxoSmithKline, AstraZeneca, Aventis, and Novartis; has pending US patent application serial number 11/176026, published as US 2006-0069074 on March 30, 2006; has received grant support from the NHLBI and the NIAID; and is on the speakers' bureau for Merck, GlaxoSmithKline, AstraZeneca, and Aventis. F. T. Leone has received grant support from the NIH, the American Lung Association, the Pennsylvania Department of Health, and the Philadelphia Department of Health and is on the speakers' bureau for Pfizer. S. P. Peters has consulting arrangements with the NIH, Adelphi, the American Thoracic Society, AstraZeneca, Discovery, Ception Therapeutics, Genentech, Novartis, Omnicare, the Rad Foundation, Respiratory Medicine, Respiratory Research, and Sanofi-Aventis; has received grant support from the NIH, the NHLBI, the American Lung Association, Abaris, AstraZeneca, Altana, Boehringer Ingelheim, Centocor, Genentech, GlaxoSmithKline, Novartis, Pfizer, and Wyeth; and has participated in physician education programs that included speakers' bureau and Continuing Medical Education programs for the American College of Chest Physicians, the American Thoracic Society, the American Academy of Allergy, Asthma, & Immunology, the American College of Allergy, Asthma and Immunology, AstraZeneca, Merck, Genentech, Novartis, Practicome, Pri-Med, Respiratory and Allergic Disease, and UpToDate. C. A. Sorkness has consulting arrangements with AstraZeneca and GlaxoSmithKline; has received grant support from GlaxoSmithKline; and is on the speakers' bureau for GlaxoSmithKline. M. E. Wechsler has consulting arrangements with Merck, Genentech, Novartis, and Pfizer and is on the speakers' bureau for Merck, GlaxoSmithKline, and Novartis. The rest of the authors have declared that they have no conflict of interest.

PII: S0091-6749(06)02337-2

doi: 10.1016/j.jaci.2006.10.035

The Journal of Allergy and Clinical Immunology
Volume 119, Issue 1 , Pages 73-80 , January 2007