The Journal of Allergy and Clinical Immunology
Volume 124, Issue 5 , Pages 895-902.e4 , November 2009

Consistently very poorly controlled asthma, as defined by the impairment domain of the Expert Panel Report 3 guidelines, increases risk for future severe asthma exacerbations in The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens (TENOR) study

  • Tmirah Haselkorn, PhD

      Affiliations

    • Genentech, Inc, South San Francisco, Calif
    • Corresponding Author InformationReprint requests: Tmirah Haselkorn, PhD, Genentech, Inc, 1 DNA Way, MS 58B, South San Francisco, CA 94080.
  • ,
  • James E. Fish, MD

      Affiliations

    • Genentech, Inc, South San Francisco, Calif
  • ,
  • Robert S. Zeiger, MD, PhD

      Affiliations

    • Department of Allergy, Kaiser Permanente Southern California, San Diego, Calif
  • ,
  • Stanley J. Szefler, MD

      Affiliations

    • Department of Pediatrics, National Jewish Health, Denver, Colo
  • ,
  • Dave P. Miller

      Affiliations

    • ICON Clinical Research, San Francisco, Calif
  • ,
  • Bradley E. Chipps, MD

      Affiliations

    • Capital Allergy and Respiratory Disease Center, Sacramento, Calif
  • ,
  • F. Estelle R. Simons, MD

      Affiliations

    • University of Manitoba, Winnipeg, Manitoba, Canada
  • ,
  • Scott T. Weiss, MD, MS

      Affiliations

    • Channing Laboratory, Harvard Medical School, Boston, Mass
  • ,
  • Sally E. Wenzel, MD

      Affiliations

    • University of Pittsburgh Asthma Institute, University of Pittsburgh School of Medicine, Pittsburgh, Pa
  • ,
  • Larry Borish, MD

      Affiliations

    • University of Virginia Health Systems, Charlottesville, Va
  • ,
  • Eugene R. Bleecker, MD

      Affiliations

    • Wake Forest University Health Sciences, Winston-Salem, NC
  • ,
  • TENOR Study Group

      Affiliations

    • For a complete list of TENOR Study Group members, please contact Genentech, Inc.

Received 23 December 2008 ,Revised 6 July 2009 ,Accepted 24 July 2009.

References 

  1. National Center for Health Statistics, Centers for Disease Control and Prevention. Asthma. Available at: http://www.cdc.gov/nchs/fastats/asthma.htm. Accessed December 16, 2008.
  2. World Health Organization. Asthma. Geneva (Switzerland). World Health Organization; 2008;
  3. Masoli M, Fabian D, Holt S, Beasley R for the Global Initiative for Asthma (GINA) Program. The global burden of asthma: executive summary of the GINA Dissemination Committee report. Allergy. 2004;59:469–478
  4. Pearce N, Aït-Khaled N, Beasley R, Mallol J, Keil U, Mitchell E, et al. Worldwide trends in the prevalence of asthma symptoms: phase III of the International Study of Asthma and Allergies in Childhood (ISAAC). Thorax. 2007;62:758–765
  5. Braman SS. The global burden of asthma. Chest. 2006;130(suppl):4S–12S
  6. Schatz M, Zeiger RS, Mosen D, Vollmer WM. Asthma-specific quality of life and subsequent asthma emergency hospital care. Am J Manag Care. 2008;14:206–211
  7. Chen H, Gould MK, Blanc PD, Miller DP, Kamath TV, Lee JH, et al. Asthma control, severity, and quality of life: quantifying the effect of uncontrolled disease. J Allergy Clin Immunol. 2007;120:396–402
  8. Weiss KB, Sullivan SD. The health economics of asthma and rhinitis. I. Assessing the economic impact. J Allergy Clin Immunol. 2001;107:3–8
  9. Zeiger RS, Hay JW, Contreras R, Chen W, Quinn VP, Seal B, et al. Asthma costs and utilization in a managed care organization. J Allergy Clin Immunol. 2008;121:885–892e5
  10. Breekveldt-Postma NS, Erkens JA, Aalbers R, van de Ven MJT, Lammers JWJ, Herings RMC. Extent of uncontrolled disease and associated medical costs in severe asthma—a PHARMO study. Curr Med Res Opin. 2008;24:975–983
  11. Accordini S, Bugiani M, Arossa W, Gerzeli S, Marinoni A, Olivieri M, et al. Poor control increases the economic cost of asthma. A multicentre population-based study. Int Arch Allergy Immunol. 2006;141:189–198
  12. Antonicelli L, Bucca C, Neri M, De Benedetto F, Sabbatani P, Bonifazi F, et al. Asthma severity and medical resource utilisation. Eur Respir J. 2004;23:723–729
  13. Sullivan SD, Wenzel SE, Bresnahan BW, Zheng B, Lee JH, Pritchard M, et al. Association of control and risk of severe asthma-related events in severe or difficult-to-treat asthma patients. Allergy. 2007;62:655–660
  14. National Heart, Lung, and Blood Institute. National Asthma Education and Prevention Program. Expert Panel Report 3: Guidelines for the diagnosis and management of asthma. Full report 2007. Bethesda: National Institutes of Health/National Heart, Lung, and Blood Institute; 2007;Publication no. 97-4051
  15. Expert Panel Report 3 (EPR-3) . guidelines for the diagnosis and management of asthma—summary report 2007. J Allergy Clin Immunol. 2007;120(suppl):S94–S138
  16. Miller MK, Lee JH, Miller DP, Wenzel SE for the TENOR Study Group. Recent asthma exacerbations: a key predictor of future exacerbations. Respir Med. 2007;101:481–489
  17. Dolan CM, Fraher KE, Bleecker ER, Borish L, Chipps B, Hayden ML, et al. Design and baseline characteristics of The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens (TENOR) study: a large cohort of patients with severe or difficult-to-treat asthma. Ann Allergy Asthma Immunol. 2004;92:32–39
  18. Chipps BE, Szefler SJ, Simons FER, Haselkorn T, Mink DR, Deniz Y, et al. Demographic and clinical characteristics of children and adolescents with severe or difficult-to-treat asthma. J Allergy Clin Immunol. 2007;119:1156–1163
  19. United States Department of Agriculture. 2000 Rural-urban commuting area codes. United States Department of Agriculture, Economic Research Service. Available at: http://www.ers.usda.gov/Data/RuralUrbanCommutingAreaCodes/2000/. Accessed December 16, 2008.
  20. United States Department of Agriculture Rural-urban commuting area codes. United States Department of Agriculture, Economic Research Service. Available at: http://www.ers.usda.gov/data/RuralUrbanCommutingAreaCodes/. Accessed December 16, 2008
  21. US Census Bureau. United States census 2000. United States Census Bureau. Available at: http://www.census.gov/main/www/cen2000.html. Accessed December 16, 2008.
  22. Ferris BG. Epidemiology Standardization Project (American Thoracic Society). Am Rev Respir Dis. 1978;118:1–120
  23. Juniper EF, Guyatt GH, Epstein RS, Ferrie PJ, Jaeschke R, Hiller TK. Evaluation of impairment of health related quality of life in asthma: development of a questionnaire for use in clinical trials. Thorax. 1992;47:76–83
  24. Juniper EF, Guyatt GH, Feeny DH, Ferrie PJ, Griffith LE, Townsend M. Measuring quality of life in children with asthma. Qual Life Res. 1996;5:35–46
  25. Juniper EF, O'Byrne PM, Guyatt GH, Ferrie PJ, King DR. Development and validation of a questionnaire to measure asthma control. Eur Respir J. 1999;14:902–907
  26. Juniper EF, Buist AS, Cox FM, Ferrie PJ, King DR. Validation of a standardized version of the Asthma Quality of Life Questionnaire. Chest. 1999;115:1265–1270
  27. American Thoracic Society. Standardization of spirometry, 1994 update. Am J Respir Crit Care Med. 1995;152:1107–1136
  28. Vollmer WM, Markson LE, O'Connor E, Sanocki LL, Fitterman L, Berger M, et al. Association of asthma control with health care utilization and quality of life. Am J Respir Crit Care Med. 1999;160:1647–1652
  29. Asthma Therapy Assessment Questionnaire (ATAQ). Whitehouse Station (NJ): Merck & Co, Inc. 2008;
  30. Schatz M, Stempel D, Allen-Ramey F, Gutierrez B, Sacco P, Sajjan S, et al. Asthma quality of care measures using administrative data: relationships to subsequent exacerbations in multiple databases. J Allergy Clin Immunol. 2008;121(suppl):S69
  31. Schatz M, Zeiger RS, Vollmer WM, Mosen D, Apter AJ, Stibolt TB, et al. Development and validation of a medication intensity scale derived from computerized pharmacy data that predicts emergency hospital utilization for persistent asthma. Am J Manag Care. 2006;12:478–484
  32. Schatz M, Mosen D, Apter AJ, Zeiger RS, Vollmer WM, Stibolt TB, et al. Relationship of validated psychometric tools to subsequent medical utilization for asthma. J Allergy Clin Immunol. 2005;115:564–570
  33. Schatz M, Cook EF, Joshua A, Petitti D. Risk factors for asthma hospitalizations in a managed care organization: development of a clinical prediction rule. Am J Manag Care. 2003;9:538–547
  34. Covar RA, Szefler SJ, Zeiger RS, Sorkness CA, Moss M, Mauger DT, et al. Factors associated with asthma exacerbations during a long-term clinical trial of controller medications in children. J Allergy Clin Immunol. 2008;122:741–747
  35. Arnold DH, Gebretsadik T, Minton PA, Higgins S, Hartert TV. Assessment of severity measures for acute asthma outcomes: a first step in developing an asthma clinical prediction rule. Am J Emerg Med. 2008;26:473–479
  36. Belessis Y, Dixon S, Thomsen A, Duffy B, Rawlinson W, Henry R, et al. Risk factors for an intensive care unit admission in children with asthma. Pediatr Pulmonol. 2004;37:201–209
  37. Castro M, Zimmermann NA, Crocker S, Bradley J, Leven C, Schechtman KB. Asthma intervention program prevents readmissions in high healthcare users. Am J Respir Crit Care Med. 2003;168:1095–1099
  38. Lafata JE, Xi H, Divine G. Risk factors for emergency department use among children with asthma using primary care in a managed care environment. Ambul Pediatr. 2002;2:268–275
  39. Vollmer WM, Markson LE, O'Connor E, Frazier EA, Berger M, Buist AS. Association of asthma control with health care utilization: a prospective evaluation. Am J Respir Crit Care Med. 2002;165:195–199
  40. Sharma HP, Matsui EC, Eggleston PA, Hansel NN, Curtin-Brosnan J, Diette GB. Does current asthma control predict future health care use among black preschool-aged inner-city children?. Pediatrics. 2007;120:e1174–e1181
  41. Apter AJ. Advances in the care of adults with asthma and allergy in 2007. J Allergy Clin Immunol. 2008;121:839–844
  42. Yoo KH, Johnson SK, Voigt RG, Campeau LJ, Yawn BP, Juhn YJ. Characterization of asthma status by parent report and medical record review. J Allergy Clin Immunol. 2007;120:1468–1469
  43. Miller JE, Gaboda D, Davis D Centers for Disease Control and Prevention/National Center for Health Statistics. Early childhood chronic illness: comparability of maternal reports and medical records. Vital Health Stat 2. 2001;131:1–10
  44. Joseph CL, Foxman B, Leickly FE, Peterson E, Ownby D. Prevalence of possible undiagnosed asthma and associated morbidity among urban schoolchildren. J Pediatr. 1996;129:735–742
  45. Jessop DJ, Stein RE. Consistent but not the same. Effect of method on chronic condition rates. Arch Pediatr Adolesc Med. 1995;149:1105–1110
  46. Sears MR. Epidemiology of asthma exacerbations. J Allergy Clin Immunol. 2008;122:662–668
  47. Miller MK, Johnson C, Miller DP, Deniz Y, Bleecker ER, Wenzel SE. Severity assessment in asthma: an evolving concept. J Allergy Clin Immunol. 2005;116:990–995
  48. Chen H, Johnson CA, Haselkorn T, Lee JH, Israel E. Subspecialty differences in asthma characteristics and management. Mayo Clin Proc. 2008;83:786–793
  49. Bender BG. Overcoming barriers to nonadherence in asthma treatment. J Allergy Clin Immunol. 2002;109(suppl):S554–S559
  50. Krishnan JA, Riekert KA, McCoy JV, Stewart DY, Schmidt S, Chanmugam A, et al. Corticosteroid use after hospital discharge among high-risk adults with asthma. Am J Respir Crit Care Med. 2004;170:1281–1285
  51. Janson SL, Earnest G, Wong KP, Blanc PD. Predictors of asthma medication nonadherence. Heart Lung. 2008;37:211–218
  52. Rand C, Bilderback A, Schiller K, Edelman JM, Hustad CM, Zeiger RS. Adherence with montelukast or fluticasone in a long-term clinical trial: results from the mild asthma montelukast versus inhaled corticosteroid trial. J Allergy Clin Immunol. 2007;119:916–923

 Supported by Genentech, Inc, and Novartis Pharmaceuticals Corporation.

 Disclosure of potential conflict of interest: J. E. Fish is an employee of Genentech. R. S. Zeiger is a consultant for Aerocrine, AstraZeneca, Genentech, GlaxoSmithKline, Merck, Novartis, and Schering and has received research support from Aerocrine, Sanofi-Aventis, Genentech, Merck & Co, and GlaxoSmithKline. S. J. Szefler is a consultant for GlaxoSmithKline, Genentech, and Merck and has received research support from the National Institutes of Health (NIH)/National Heart, Lung, and Blood Institute (NHLBI) Childhood Asthma Management Program (CAMP), NHLBI Childhood Asthma Research and Education, the NIH/NHLBI Asthma Clinical Research Network, the NIH/National Institute of Allergy and Infectious Diseases Inner City Asthma Consortium, Roos Pharmaceuticals, and GlaxoSmithKline. D. P. Miller is employed by ICON Clinical Research, which received research funding from Genentech. B. E. Chipps has received research support from Genentech, Alcon, and AstraZeneca; has provided expert witness testimony for AstraZeneca regarding Symbicort research; and is a consultant on the speakers' bureau for Sepracor, GlaxoSmithKline, AstraZeneca, Alcon, Genentech, Novartis, Schering-Plough, Aventis, MADA. F. E. R. Simons has received research support from the Canadian Institutes of Health Research. S. T. Weiss is a consultant for Genentech. S. E. Wenzel has received research support from GlaxoSmithKline and is an advisory board member for the Global Initiative for Asthma. L. Borish is a consultant for Genentech, is on the speakers' bureau for Merck, and has received research support from GlaxoSmithKline. E. R. Bleecker is a consultant for AstraZeneca, Boehringer-Ingelheim, Centocor, Genentech, GlaxoSmithKline, Novartis, Pfizer, Wyeth, and Merck and has received research support through Wake Forest University Health Sciences, Aerovance, Amgen, AstraZeneca, Boehringer-Ingelheim, Centocor, Ception, Genentech, GlaxoSmithKline, Novartis, Novartis, Pfizer, and Wyeth. T. Haselkorn has been a paid consultant to Genentech since December 2002.

PII: S0091-6749(09)01144-0

doi: 10.1016/j.jaci.2009.07.035

The Journal of Allergy and Clinical Immunology
Volume 124, Issue 5 , Pages 895-902.e4 , November 2009