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Detection of exacerbations in asthma based on electronic diary data: results from the 1-year prospective BIOAIR study.

Thorax (2013-04-09)
Maciej Kupczyk, Shushila Haque, Peter J Sterk, Ewa Niżankowska-Mogilnicka, Alberto Papi, Elisabeth H Bel, Pascal Chanez, Barbro Dahlén, Mina Gaga, Mark Gjomarkaj, Peter H Howarth, Sebastian L Johnston, Guy F Joos, Frank Kanniess, Eleni Tzortzaki, Anna James, Roelinde J M Middelveld, Sven-Erik Dahlén
RESUMEN

Objective measures are required that may be used as a proxy for exacerbations in asthma. The aim was to determine the sensitivity and specificity of electronic diary data to detect severe exacerbations (SEs) of asthma. A secondary aim was to identify phenotypic variables associated with a higher risk of exacerbation. In the BIOAIR study, 169 patients with asthma (93 severe (SA); 76 mild to moderate (MA)) recorded lung function, symptoms and medication use in electronic diaries for 1 year. Data were analysed using receiver-operator characteristics curves and related to physician-diagnosed exacerbations. Medical history and baseline clinical data were used to assess risk of exacerbation. Of 122 physician-diagnosed exacerbations, 104 occurred in the SA group (1.1 per patient/year), 18 in the MA group (0.2 per patient/year) and 63 were severe using American Thoracic Society/European Respiratory Society criteria. During exacerbations, peak expiratory flow (PEF) and forced expiratory volume in 1 s significantly decreased, whereas day and night symptoms significantly increased. An algorithm combining a 20% decrease in PEF or a 20% increase in day symptoms on 2 consecutive days was able to detect SEs with 65% sensitivity and 95% specificity. The strongest risk factors for SEs were low Asthma Control Questionnaire score, sputum eosinophils ≥ 3%, body mass index >25 and low quality of life (St George's Respiratory Questionnaire), with ORs between 3.61 and 2.22 (p<0.05). Regular electronic monitoring of PEF and asthma symptoms provides an acceptable sensitivity and specificity for the detection of SEs and may be suitable for personal internet-based monitoring of asthma control.

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Budesonide, ≥99%
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Budesonide, Pharmaceutical Secondary Standard; Certified Reference Material
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Budesonide, European Pharmacopoeia (EP) Reference Standard
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