Use of the Asthma Control Questionnaire to predict future risk of asthma exacerbation

doi:10.1016/j.jaci.2010.08.042

Journal of Allergy and Clinical Immunology

Volume 127, Issue 1, January 2011, Pages 167-172

https://doi.org/10.1016/j.jaci.2010.08.042 Get rights and content

Background

Direct correlation of assessments of a validated composite measure such as the Asthma Control Questionnaire (ACQ) and risk of exacerbation has not been previously demonstrated in a randomized controlled trial.

Objective

To evaluate the ability of the ACQ score over time to predict risk of a future asthma exacerbation.

Methods

This analysis included data from a 12-week placebo-controlled trial (N = 292) of AMG 317, an IL-4 receptor α antagonist, in patients with moderate to severe atopic asthma. At baseline, patients had an ACQ score ≥1.5. Exacerbations were defined as requirement for systemic corticosteroids. A Cox proportional hazards model was used, with ACQ score as the time-dependent covariate. The analysis was repeated for individual components of the ACQ.

Results

Each 1-point increase in ACQ was associated with a 50% increased risk of exacerbation (hazard ratio, 1.50; 95% CI, 1.03-2.20) for the following 2-week period. Evaluation of individual ACQ components also demonstrated a similar trend, though each to a lesser degree than the full composite ACQ.

Conclusion

Although based on a retrospective analysis, with small number of exacerbations, these findings support the utility of the composite ACQ score measurement to predict risk of future exacerbation in clinical trials and clinical practice. The composite ACQ score measurement was found to be a better predictor of future risk than individual ACQ components.

Section snippets

Patients

A post hoc analysis of data from a 12-week multicenter, double-blind, randomized, placebo-controlled clinical trial¹⁶ was conducted to assess the association between the ACQ and asthma exacerbation. Patients with moderate to severe atopic asthma were enrolled in a dose-ranging phase 2 study to assess the safety and efficacy of AMG 317, an IL-4 receptor α antagonist. Patients were randomly assigned in a 1:1:1:1 ratio to receive 1 of 3 doses of the IL-4 receptor α antagonist or placebo

Patients

A total of 292 patients with moderate to severe asthma were included in the analysis. The study population was 71% white, 18% black, 58% women, and had a mean age of 41 years (Table I). At baseline, patients had a mean FEV₁ of 68.3% and mean ACQ score of 2.54. Baseline characteristics were similar between patients with and without an exacerbation. All baseline characteristics were considered for the final model; none were determined as potential confounders relative to exacerbations.

ACQ and exacerbations

Asthma

Discussion

In this retrospective analysis of data from a randomized clinical trial, asthma control as measured by the ACQ composite score was found to be significantly associated with the risk of future exacerbation. This finding was confirmed with the analysis demonstrating consistently higher odds of having an exacerbation with an increase in the proximate ACQ score. A direct correlation between sequential measurements of ACQ, an indicator of asthma impairment, and the risk of future exacerbation, as

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: Supported by Amgen Inc.

: Trial registration: This study is registered with ClinicalTrials.gov with the identifier NCT 00436670.

: Disclosure of potential conflict of interest: E. O. Meltzer has received research support from UCB, Alcon, Alexza, Amgen, Antigen Labs, Apotex, Astellas, AstraZeneca, Boehringer Ingelheim, Capnia, Critical Therapeutics, GlaxoSmithKline, MAP, MEDA, Merck, Novartis, Proctor & Gamble, Schering-Plough, and Teva; has served as a consultant or on an advisory board for Schering Plough, Alcon, Alexza Pharmaceuticals, Amgen, AstraZeneca, Boehringer Ingelheim, Capnia, Dainippon Sumitomo Pharma, Dey, ISTA, Johnson & Johnson, Kalypsys, MAP, Meda, Merck, National Jewish Health, Rady Children's Hospital San Diego, Sandoz, Sepracor, SRxA, Teva, VentiRx, Wockhardt, and Wyeth; is a speaker for GlaxoSmithKline, MEDA, Merck, Sanofi-Aventis, Schering-Plough, Sepracor, and SRxA; has served as an expert in legal matters on the topics of desloratadine, fexofenadine, montelukast, and levocetirizine; and is a fellow for the AAAAI and the American College of Allergy, Asthma and Immunology. W. W. Busse is on the advisory board for Altair, GlaxoSmithKline, Merck, Wyeth, Pfizer Centocor, Amgen, and Johnson & Johnson; is a speaker for Merck; is a consultant for Novartis, Astra Zeneca, TEVA, Boehringer Ingelhim, and GlaxoSmith-Kline; and has received research support from NIH-NIAID, NIH-NHLBI, Novartis, AstraZeneca, GlazoSmithKline, MedImmune, and Ception. S. E. Wenzel is a consultant for GlaxoSmithKline, Merck, Amgen, and Pearl Therapeutics; is on the advisory board for Amira, Altair, and Epigenesis; and has received research support from GlaxoSmithKline, Amgen, and MedImmune. V. Belozeroff, H. H. Weng, D. Globe, and S.-L. Lin are employed by Amgen. Y. Chon holds stock in Amgen. The rest of the authors have declared that they have no conflict of interest.

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Asthma and lower airway diseaseUse of the Asthma Control Questionnaire to predict future risk of asthma exacerbation

Background

Objective

Methods

Results

Conclusion

Section snippets

Patients

Patients

ACQ and exacerbations

Discussion

J Allergy Clin Immunol

J Allergy Clin Immunol

J Allergy Clin Immunol

Chest

Respir Med

Respir Med

J Allergy Clin Immunol

Chest

The global burden of asthma: executive summary of the GINA Dissemination Committee report

Allergy

The burden of asthma in the United States: level and distribution are dependent on interpretation of the national asthma education and prevention program guidelines

Am J Respir Crit Care Med

Clinical management of asthma in 1999: the Asthma Insights and Reality in Europe (AIRE) study

Eur Respir J

Suboptimal asthma control: prevalence, detection and consequences in general practice

Eur Respir J

Asthma and lower airway disease
Use of the Asthma Control Questionnaire to predict future risk of asthma exacerbation