The Journal of Allergy and Clinical Immunology
Volume 119, Issue 1 , Pages 64-72 , January 2007

Long-term comparison of 3 controller regimens for mild-moderate persistent childhood asthma: The Pediatric Asthma Controller Trial

  • Christine A. Sorkness, PharmD

      Affiliations

    • Clinical Science Center, University of Wisconsin, Madison
    • Corresponding Author InformationReprint requests: Christine A. Sorkness, PharmD, K4/950 University of Wisconsin Clinical Science Center, 600 Highland Avenue, Madison, WI 53792-3244.
    • ,
  • Robert F. Lemanske Jr., MD

      Affiliations

    • Clinical Science Center, University of Wisconsin, Madison
    • ,
  • David T. Mauger, PhD

      Affiliations

    • Department of Health Evaluation Sciences, Pennsylvania State University, Hershey
    • ,
  • Susan J. Boehmer, MA

      Affiliations

    • Department of Health Evaluation Sciences, Pennsylvania State University, Hershey
    • ,
  • Vernon M. Chinchilli, PhD

      Affiliations

    • Department of Health Evaluation Sciences, Pennsylvania State University, Hershey
    • ,
  • Fernando D. Martinez, MD

      Affiliations

    • From the Arizona Respiratory Center, University of Arizona, Tucson
    • ,
  • Robert C. Strunk, MD

      Affiliations

    • Department of Pediatrics, Washington University, St Louis
    • ,
  • Stanley J. Szefler, MD

      Affiliations

    • Department of Pediatrics, National Jewish and Research Center and University of Colorado Health Sciences Center, Denver
    • ,
  • Robert S. Zeiger, MD, PhD

      Affiliations

    • Department of Pediatrics, University of California–San Diego
    • Department of Allergy, Kaiser Permanente, San Diego
    • ,
  • Leonard B. Bacharier, MD

      Affiliations

    • Department of Pediatrics, Washington University, St Louis
    • ,
  • Gordon R. Bloomberg, MD

      Affiliations

    • Department of Pediatrics, Washington University, St Louis
    • ,
  • Ronina A. Covar, MD

      Affiliations

    • Department of Pediatrics, National Jewish and Research Center and University of Colorado Health Sciences Center, Denver
    • ,
  • Theresa W. Guilbert, MD

      Affiliations

    • From the Arizona Respiratory Center, University of Arizona, Tucson
    • ,
  • Gregory Heldt, MD

      Affiliations

    • Department of Pediatrics, University of California–San Diego
    • ,
  • Gary Larsen, MD

      Affiliations

    • Department of Pediatrics, National Jewish and Research Center and University of Colorado Health Sciences Center, Denver
    • ,
  • Michael H. Mellon, MD

      Affiliations

    • Department of Allergy, Kaiser Permanente, San Diego
    • ,
  • Wayne J. Morgan, MD

      Affiliations

    • From the Arizona Respiratory Center, University of Arizona, Tucson
    • ,
  • Mark H. Moss, MD

      Affiliations

    • Clinical Science Center, University of Wisconsin, Madison
    • ,
  • Joseph D. Spahn, MD

      Affiliations

    • Department of Pediatrics, National Jewish and Research Center and University of Colorado Health Sciences Center, Denver
    • ,
  • Lynn M. Taussig, MD

      Affiliations

    • Department of Pediatrics, National Jewish and Research Center and University of Colorado Health Sciences Center, Denver
    • ,
  • for the Childhood Asthma Research and Education Network of the National Heart, Lung, and Blood Institute

Received 9 June 2006 ,Revised 30 August 2006 ,Accepted 5 September 2006.

  • Image Result

    Cascade of enrollment. ∗Reasons for exclusion during the run-in period were mild intermittent asthma classification (n = 84), severe persistent asthma classification (n = 36), nonadherent/exclusionary

    Cascade of enrollment. ∗Reasons for exclusion during the run-in period were mild intermittent asthma classification (n = 84), severe persistent asthma classification (n = 36), nonadherent/exclusionary medication use (n = 47), inability to swallow study capsule (n = 39), FEV1 < 80% predicted at screen (n = 42), upper respiratory infection/prednisone burst (n = 36), PC20 > 12.5 mg/mL (n = 38), withdrew consent (n = 21), inability to perform spirometry (n = 13), and other reasons (n = 7). †Study visit activities included spirometry, impulse oscillometry, eNO, adherence review, asthma control and health care utilization questionnaire, adverse event evaluation, and height measurement via calibrated stadiometer.

  • Image Result
    A, Biweekly average of the percentage of asthma control days change from baseline during the 48-week treatment period for the 3 treatment groups: PACT combination therapy (C), fluticasone monotherapy

    A, Biweekly average of the percentage of asthma control days change from baseline during the 48-week treatment period for the 3 treatment groups: PACT combination therapy (C), fluticasone monotherapy (F), and montelukast monotherapy (M). The 3 treatment groups were compared longitudinally across the entire study period by repeated-measures ANOVA. P values given are those associated with the main-effect comparison of the 2 study groups indicated for that P value. B and C, Kaplan-Meier estimates for times to first course of prednisone and times to treatment failure for the 3 treatments: PACT combination therapy, fluticasone monotherapy, and montelukast monotherapy. P values given are those associated with the log-rank test comparison of the 2 study groups indicated for that P value. ACD, Asthma control days.

  • Image Result
    ACQ (A), eNO (B), percent predicted FEV1 (C), and FEV1/FVC ratio (D). Average change from baseline at each study visit for the 3 treatment groups: PACT combination therapy (C), fluticasone monotherapy

    ACQ (A), eNO (B), percent predicted FEV1 (C), and FEV1/FVC ratio (D). Average change from baseline at each study visit for the 3 treatment groups: PACT combination therapy (C), fluticasone monotherapy (F), and montelukast monotherapy (M). The 3 treatment groups were compared longitudinally across the entire study period by repeated-measures ANOVA. P values given are those associated with the main-effect comparison of the 2 study groups indicated for that P value. eNO data were analyzed on the log-scale, and the changes across time are presented graphically as the relative change from baseline expressed as a percentage BD, Bronchodilator.

 Supported by grants HL064307, HL64288, HL064295, HL64287, and HL064305 from the National Heart, Lung and Blood Institute. This study was performed in part by the General Clinical Research Centers at Washington University School of Medicine (M01 RR00036), National Jewish Medical and Research Center (M01 RR00051), and the University of Wisconsin (M01 RR03186).Disclosure of potential conflict of interest: C. A. Sorkness has consultant arrangements with GlaxoSmithKline and AstraZeneca, has received grant support from GlaxoSmithKline and Pharmaxis, and is on the speakers' bureau for GlaxoSmithKline and Genentech. R. F. Lemanske has consultant arrangements with GlaxoSmithKline, Merck, AstraZeneca, Aventis, and Novartis, has received grant support from the National Heart, Lung, and Blood Institute (NHLBI), and is on the speakers' bureau for Merck, AstraZeneca, GlaxoSmithKline, and Aventis. D. T. Mauger, S. J. Boehmer, and V. M. Chinchilli have received grant support from the National Institutes of Health (NIH). F. D. Martinez has had consultant arrangements with Genentech and Pfizer, has served on the advisory board for Merck, and has received an honorarium for a lecture at a meeting sponsored by Merck. S. J. Szefler has consultant arrangements with AstraZeneca, GlaxoSmithKline, Aventis, Genentech, and Merck, and has received grant support from the NIH, NHLBI, National Institute of Allergy and Infectious Diseases, and Ross Pharmaceuticals. R. S. Zeiger has consultant arrangements with Aerocrine, AstraZeneca, Genentech, GlaxoSmithKline, Merck, Novartis, and Sanofi-Aventis, and has received grant support from AstraZeneca, GlaxoSmithKline, Merck, Sanofi-Aventis, and TEVA Pharmaceuticals. L. B. Bacharier has received grant support from the NIH and NHLBI, and is on the speakers' bureau for Merck, GlaxoSmithKline, AstraZeneca, and Genentech. R. A. Covar has received grant support from AstraZeneca. T. W. Guilbert has participated on an advisory board sponsored by GlaxoSmithKline and as a consultant in the design of Continuing Medical Education (CME) courses and for asthma for the Innovia Medical Educational Institute, and has received consultant fees from GlaxoSmithKline and stocks or revenue from speakers' bureaus, research, or grant activities from GlaxoSmithKline, AstraZeneca, Merck, and Pfizer, and is on the speakers' bureau for GlaxoSmithKline, AstraZeneca, SOMA Medical Education (CME), Innovia Medical Education Institute (CME), Antidote (formerly Medical World Conferences, CME), and Health Matters. G. Larsen has consultant arrangements with GlaxoSmithKline and Schering Plough, and has received grant support from the NIH. M. H. Mellon is on the speakers' bureau for AstraZeneca, Schering Plough, and Altana. W. J. Morgan has consultant arrangements with Genentech and has patent licensing arrangements with the Wisconsin Alumni Research Foundation. J. D. Spahn has consultant arrangements with GlaxoSmithKline and AstraZeneca, has received grant support from Merck, AstraZeneca, and GlaxoSmithKline, and is on the speakers' bureau for GlaxoSmithKline. L. M. Taussig has consultant arrangements with GlaxoSmithKline. The rest of the authors have declared that they have no conflict of interest.

PII: S0091-6749(06)02122-1

doi: 10.1016/j.jaci.2006.09.042

The Journal of Allergy and Clinical Immunology
Volume 119, Issue 1 , Pages 64-72 , January 2007

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