Asthma and lower airway disease
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

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Background

Identification of patients at risk for asthma exacerbations can assist physicians in addressing disease management and improve asthma-related health outcomes.

Objective

We sought to evaluate whether level of impairment, as defined by the 2007 asthma guidelines, predicts risk for future asthma exacerbations.

Methods

The study included children aged 6 to 11 years (n = 82) and adolescent/adult patients aged 12 years and older (n = 725) from The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens study with data representing all components of the impairment domain of the asthma guidelines at baseline, month 12, and month 24. Patients were categorized into 2 cohorts: (1) consistently very poorly controlled (VPC) asthma from baseline through 2 years of follow-up and (2) improved from VPC asthma at baseline (including patients who improved to not well-controlled or well-controlled asthma), with improvement maintained through 2 years of follow-up. Odds ratios (ORs) and 95% CIs for risk of asthma exacerbations at month 30 were generated by using multivariable logistic regression by age group.

Results

After adjustment, children with consistently VPC asthma over the 2-year period demonstrated a 6-fold increased risk of hospitalization, emergency department visit, or corticosteroid burst (OR, 6.4; 95% CI, 1.2-34.5) compared with the improved group. Adolescent/adult patients with consistently VPC asthma were more likely to have a corticosteroid burst (OR, 2.8; 95% CI, 1.7-4.8) or have a hospitalization, emergency department visit, or corticosteroid burst (OR, 3.2; 95% CI, 1.9-5.3).

Conclusions

Consistently VPC asthma, as defined by the impairment domain of the 2007 asthma guidelines, is strongly predictive of future asthma exacerbations.

Section snippets

Study population

Full details of the TENOR study have been reported elsewhere.17, 18 This was a 3-year (2001-2004), multicenter, prospective cohort study of 4756 patients aged 6 years or more with severe or difficult-to-treat asthma. Inclusion/exclusion criteria are described in Table E1 (available in this article's Online Repository at www.jacionline.org). Patients were enrolled from diverse geographic sites in the United States to reflect the variety of different settings in which patients with asthma receive

Patient characteristics

Baseline demographics and clinical characteristics for children and adolescents/adults in each cohort (consistently VPC asthma and improved from VPC asthma) are shown in Table I, Table II. Most (62.2%) of the children were consistently classified as having VPC asthma. Children who had VPC asthma were less likely to have private insurance (P = .028) and more likely to be treated by a pulmonologist (P = .003). Among the clinical measures (Table II), children who were consistently classified as

Discussion

This analysis of TENOR study patients with severe or difficult-to-treat asthma demonstrated that having consistently VPC asthma over time, as defined by the impairment domain of the 2007 NHLBI asthma guidelines, predicts future risk for asthma exacerbations. This was evidenced by significantly higher risks for the composite outcome of hospitalizations, ED visits, or corticosteroid bursts in both children and adolescents/adults who had consistently VPC asthma compared with patients who improved

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    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.

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

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