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Abstract
This study aimed to investigate the effect of treating patients with moderate asthma with formoterol on quality of life (QoL) and to compare several questionnaires in their ability to detect changes in QoL. In an eight month multicentre, randomized, placebo-controlled trial, patients with asthma using daily inhaled corticosteroids and beta2-agonists (> or = 5 inhalations x week(-1)) were randomized to 6 months treatment with formoterol 24 microg b.i.d. (by Turbuhaler) or a matching placebo. Patients recorded symptoms (maximal score 21) and peak expiratory flow (PEF) twice daily. QoL was measured with two asthma-specific questionnaires, the Asthma Quality of Life Questionnaire (AQLQ) and the Living with Asthma Questionnaire (LWAQ), and with two generic QoL forms, i.e. the Short Form 36 (SF36) and the Psychological and General Well-Being scale (PGWB) at randomization and after 6 months of treatment. Out of 110 patients studied, 56 received formoterol and 54 placebo. Mean baseline forced expiratory volume in one second was 65% predicted. Mean morning PEF was 369 L x min(-1). Mean total symptom score was 3.6. Morning PEF increased (26.8 L x min(-1), p=0.0001) and symptoms decreased (-1.23, p=0.012) in the formoterol group in contrast to placebo. QoL improvements were measured in the LWAQ total score (baseline 0.61, change -0.05, p=0.048) and the physical construct of the LWAQ (baseline 0.71, change 0.07, p=0.044). The AQLQ and the generic QoL instruments showed no significant changes. In conclusion, the improvement in quality of life reported after 6 months was very small and only reflected by the Living with Asthma Questionnaire.
Highlights
In an eight month multicentre, randomized, placebo-controlled trial, patients with asthma using daily inhaled corticosteroids and β2-agonists (Š5 inhalations·week-1) were randomized to 6 months treatment with formoterol 24 μg b.i.d. or a matching placebo
quality of life (QoL) was measured with two asthma-specific questionnaires, the Asthma Quality of Life Questionnaire (AQLQ) and the Living with Asthma Questionnaire (LWAQ), and with two generic QoL forms, i.e. the Short Form 36 (SF36) and the Psychological and General Well-Being scale (PGWB) at randomization and after 6 months of treatment
The LWAQ total score and the physical problem construct of the LWAQ improved significantly (p
Summary
In an eight month multicentre, randomized, placebo-controlled trial, patients with asthma using daily inhaled corticosteroids and β2-agonists (Š5 inhalations·week-1) were randomized to 6 months treatment with formoterol 24 μg b.i.d. (by Turbuhaler®) or a matching placebo. Measurement of quality of life (QoL) is increasingly being used in clinical intervention studies and has been shown to be a valid indicator in assessing whether a medical treatment is beneficial [1,2,3,4]. The assessment of QoL is regarded as being one of the main outcome variables in clinical studies [5, 6], especially in chronic diseases such as asthma, in which a cure by medical intervention is seldom achieved. In this respect, QoL is referred to as the daily functioning and the subjective wellbeing of the pat-ient. The question is whether this is dependent on the kind of questionnaire used or whether patients do not perceive a substantial improvement in their QoL as recorded on any kind of questionnaire
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