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.

  • Image Result

    Protocol time line with the different interventions. Stratification is based on the 6-week ICS response: responders and nonresponders. Baseline and repeat measurements included the biomarkers of β2-ag

    Protocol time line with the different interventions. Stratification is based on the 6-week ICS response: responders and nonresponders. Baseline and repeat measurements included the biomarkers of β2-agonist response, FeNO, and induced sputum eosinophils. Duration of asthma diagnosis was initially obtained. The mini ACQ was measured prior to the 16-week trial and once every month during the 16 weeks. bid, Twice daily; D/C, discontinued.

  • Image Result
    The FEV1 distribution response to inhaled corticosteroid over the short-term 6-week trial. Bars represent 5% increments in FEV1 response.

    The FEV1 distribution response to inhaled corticosteroid over the short-term 6-week trial. Bars represent 5% increments in FEV1 response.

  • Image Result
    Induced sputum characteristics stratified by inhaled corticosteroid response (post 6-week trial, before long-term trial). Horizontal lines represent 25th, 50th, and 75th percentiles.

    Induced sputum characteristics stratified by inhaled corticosteroid response (post 6-week trial, before long-term trial). Horizontal lines represent 25th, 50th, and 75th percentiles.

  • Image Result
    Asthma control as measured by the ACQ over the 16-week ICS or placebo (PBO) continuation trial. The groups are categorized on the basis of the FEV1 results of the previous 6-week ICS trial: nonrespond

    Asthma control as measured by the ACQ over the 16-week ICS or placebo (PBO) continuation trial. The groups are categorized on the basis of the FEV1 results of the previous 6-week ICS trial: nonresponders ≤5% improvement on ICS; responders >5% improvement on ICS. The only significant within-group difference occurred between PBO and ICS responder groups (P = .007).

 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

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