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1 Cooperative Research Centre for Asthma, University of Sydney, Sydney. 2 Woolcock Institute of Medical Research, Camperdown. 3 Dept of Allergy, Immunology and Respiratory Medicine, The Alfred Hospital, and Monash University, Melbourne, and 4 Dept of Respiratory Medicine, Westmead Hospital, Westmead, Australia.
CORRESPONDENCE: C. R. Jenkins, Woolcock Institute of Medical Research, PO Box M77, Missenden Road, Camperdown, New South Wales 2050, Australia. Fax: 61 295506115. E-mail: crj@woolcock.org.au
Keywords: Asthma treatment, lung function, patient-centred outcomes, quality of life
Received: December 17, 2004
Accepted March 30, 2005
Lung function is commonly used as the primary endpoint in asthma clinical trials, but it may not reflect changes which are important to patients. The present study compared changes in, and relationships between, traditional and patient-centred end-points during treatment with three classes of asthma medication.
Subjects with mild-to-moderate asthma were randomised to double-blind, double-dummy crossover treatment with eformoterol 12 µg b.i.d. or montelukast 10 mg q.d., then single-blind treatment with fluticasone 250 µg b.i.d./placebo capsules, with 6-week treatment periods and 1-week washouts. Individual "traditional" end-points (symptoms, reliever use, forced expiratory volume in one second per cent predicted, morning peak expiratory flow, airway hyperresponsiveness) and "patient-centred" end-points (asthma control questionnaire, quality of life, patient global assessments) were assessed. Principal component analysis and linear modelling were used to explore overall rank orders for treatment, and relationships between outcomes.
A total of 58 subjects were randomised. The rank order of benefit from eformoterol and fluticasone differed for three factors derived from principal component analysis (eformoterol>fluticasone for symptom/reliever use factor, fluticasone>eformoterol for lung function factor, eformoterol = fluticasone for patient-centred factor). Montelukast was ranked third for all three factors. A significant relationship between patient-based variables and lung function was found only for montelukast treatment.
In asthma treatment, traditional end-points do not fully capture patient-centred benefits, and the relationship between end-points differs with medication class.
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