The Journal of Allergy and Clinical Immunology
Volume 122, Issue 4 , Pages 741-747.e4 , October 2008

Factors associated with asthma exacerbations during a long-term clinical trial of controller medications in children

  • Ronina A. Covar, MD

      Affiliations

    • Department of Pediatrics, National Jewish Medical and Research Center and University of Colorado Health Sciences Center, Denver, Colo
    • Corresponding Author InformationReprint requests: Ronina A. Covar, MD, National Jewish Medical and Research Center, 1400 Jackson Street, Denver, CO 80206.
    • ,
  • Stanley J. Szefler, MD

      Affiliations

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

      Affiliations

    • Department of Pediatrics, University of California San Diego, and the Department of Allergy, Kaiser Permanente, San Diego, Calif
    • ,
  • Christine A. Sorkness, PharmD

      Affiliations

    • Clinical Science Center, University of Wisconsin, and the Department of Pediatrics, University of California-San Diego, San Diego, Calif
    • ,
  • Mark Moss, MD

      Affiliations

    • Clinical Science Center, University of Wisconsin, and the Department of Pediatrics, University of California-San Diego, San Diego, Calif
    • ,
  • David T. Mauger, PhD

      Affiliations

    • Department of Public Health Sciences, Pennsylvania State University, Hershey, Pa
    • ,
  • Susan J. Boehmer, PhD

      Affiliations

    • Department of Public Health Sciences, Pennsylvania State University, Hershey, Pa
    • ,
  • Robert C. Strunk, MD

      Affiliations

    • Department of Pediatrics, Washington University, St Louis, Mo
    • ,
  • Fernando D. Martinez, MD

      Affiliations

    • Arizona Respiratory Center, University of Arizona, Tucson, Ariz
    • ,
  • Lynn M. Taussig, MD

      Affiliations

    • Department of Pediatrics, National Jewish Medical and Research Center and University of Colorado Health Sciences Center, Denver, Colo
    • ,
  • Childhood Asthma Research and Education Network

Received 19 April 2008 ,Revised 22 August 2008 ,Accepted 25 August 2008.

  • Image Result

    Numbers of participants in the PACT with no, 1, 2, and 3 exacerbations in each treatment group. Forty-eight percent had at least 1 exacerbation, and 22% had more than 1 exacerbation. Fewer participant

    Numbers of participants in the PACT with no, 1, 2, and 3 exacerbations in each treatment group. Forty-eight percent had at least 1 exacerbation, and 22% had more than 1 exacerbation. Fewer participants in the FP monotherapy group developed an asthma exacerbation during the trial compared with those who were treated with montelukast (P = .009 FP monotherapy vs montelukast; P = .09 FP monotherapy vs PACT combination; P = .2 PACT combination vs montelukast).

  • Image Result
    Number of exacerbations in the winter (Dec-Feb), spring (Mar-May), summer (June-Aug), and fall (Sept-Nov) months. Exacerbations were more likely to occur in the spring (P < .001) or winter (P = .001)

    Number of exacerbations in the winter (Dec-Feb), spring (Mar-May), summer (June-Aug), and fall (Sept-Nov) months. Exacerbations were more likely to occur in the spring (P < .001) or winter (P = .001) or fall (P < .0001) than in the summer.

  • Image Result
    Plots of cough/wheeze severity score (scale 0-3), rescue albuterol rescue use (no. of inhalations per day), and am PEF as percent predicted of participants in the montelukast (blue), PACT combination

    Plots of cough/wheeze severity score (scale 0-3), rescue albuterol rescue use (no. of inhalations per day), and am PEF as percent predicted of participants in the montelukast (blue), PACT combination (green), and FP monotherapy (orange) groups, relative to an exacerbation.

  • Image Result
    Sensitivity values expressed as percentages of participants in the different treatment groups (montelukast, blue; PACT combination, green; and FP monotherapy, orange) reporting any of or combination o

    Sensitivity values expressed as percentages of participants in the different treatment groups (montelukast, blue; PACT combination, green; and FP monotherapy, orange) reporting any of or combination of the following recent changes: (A) symptoms (ie, 2-point increase); (B) albuterol use (at least 8 inhalations per day of the exacerbations); (C) PEF (20% reduction); and (D) any of the 3 changes.

 Supported by grants 5U10HL064287, 5U10HL064288, 5U10HL064295, 5U10HL064307, 5U10HL064305, and 5U10HL064313 from the National Heart, Lung, and Blood Institute; General Clinical Research Centers at Washington University School of Medicine (M01 RR00036); and National Jewish Medical and Research Center (M01 RR00051).

 Disclosure of potential conflict of interest: R. A. Covar has received honoraria from Aerocrine NIOX and has received research support as a coinvestigator from Abbott Laboratories. S. J. Szefler has served as a consultant for AstraZeneca, GlaxoSmithKline, Aventis, Genentech, and Merck and has received research grants from the National Institutes of Health (NIH)/National Heart, Lung, and Blood Institute (NHLBI) Childhood Asthma Management Program, NHLBI Childhood Asthma Research and Education, the NIH/NHLBI Asthma Clin Res Network, the NIH/National Institute of Allergy and Infectious Diseases Inner-City Asthma Consortium, and Ross Pharmaceuticals. R. S. Zeiger has served as a consultant for Aerocrine, AstraZeneca, Dynavax, Genentech, Merck, Novartis, and GlaxoSmithKline and has received research support from Sanofi-Aventis, Teva-Pharmaceuticals, Merck, AstraZeneca, GlaxoSmithKline, and Genentech. C. A. Sorkness has served on the speakers' bureau for GlaxoSmithKline and has received research support from GlaxoSmithKline and Pharmaxis. The rest of the authors have declared that they have no conflict of interest.

PII: S0091-6749(08)01552-2

doi: 10.1016/j.jaci.2008.08.021

The Journal of Allergy and Clinical Immunology
Volume 122, Issue 4 , Pages 741-747.e4 , October 2008

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