Asthma quality of life during 1 year of treatment with budesonide with or without formoterol

Abstract

The Formoterol and Corticosteroids Establishing Therapy (FACET) study has provided the first opportunity to examine the long-term effects of inhaled steroids and long-acting b 2 -agonists on asthma-specific quality of life. The objectives of the present study were to: evaluate the effects of long-term (1 yr) formoterol and increasing doses of budesonide on asthma quality of life; 2) to determine whether initial improvements in quality of life are sustained when improvements in clinical indices persist; and 3) to evaluate the long-term relationship between changes in clinical indices and changes in quality of life.Of the 852 asthmatic adults enrolled, 470 from five countries participated in this quality of life evaluation. After a 4-week run-in on 1,600 mg budesonide, patients were randomized to either 200 mg (Bud200) or 800 mg budesonide (Bud800) in combination with either 24 mg formoterol (F) or placebo daily for 1 yr. The Asthma Quality of Life Questionnaire (AQLQ) was completed and conventional clinical indices measured at enrolment and randomization and on seven occasions during the following 12 months.During the run-in, there was an improvement in AQLQ score (changes (D) in overall score<0.50; p<0.0001). After randomization, there was a further improvement in the Bud800+F group (D=0.21; p=0.028). One month post-randomization, improvements in all groups stabilized and were sustained throughout the 12 months in a pattern very similar to that observed for the conventional clinical indices. The correlation of individual patient changes in clinical indices and changes in AQLQ score during the 12-month randomized period were weak to moderate (maximum r=0.51).Improvements in quality of life, which were greatest in the 800 mg budesonide plus 24 mg formoterol group, were sustained throughout the 12 months in a similar manner to the clinical indices. Long-term changes in conventional clinical indices cannot be used to predict the effect of treatment on individual patient experience. Eur Respir J 1999; 14: 1038±1043. Supported by Astra Draco AB, Sweden.The primary hypothesis tested in the Formoterol and Corticosteroids Establishing Therapy (FACET) study was that the addition of regular treatment with the long-acting inhaled b 2 -agonist, formoterol, to a lower and higher dose of the inhaled glucocorticosteroid budesonide would result in improved control of symptoms and lung function, without any long-term deterioration in the control of asthma over a 12-month period [1]. The results showed that the addition of formoterol to both doses of inhaled steroid improved asthma symptoms and resulted in a decrease in the rate of severe and mild asthma exacerbations.A secondary objective of the FACET study was to determine the effect of these interventions on health-related quality of life (HRQL). Although short-term studies have shown that both inhaled steroids and long-acting b 2 -agonists are associated with an improvement in asthma-specific quality of life [2±8], there have been no longer-term studies ($1 yr) of th...

Relationship between guideline treatment and health-related quality of life in asthma

“…Thus the differences observed of 0.4 points in overall HRQL, as well as in the symptoms subscale, and of 0.6 points in the environmental exposure subscale are not only statistically significant but also borderline clinically relevant. Non-guideline treatment seems to have the least effect on emotional function of the asthma patients, which is in line with other studies in which the treatment regime appeared to have more impact on symptoms and environmental exposure than on emotional function [23].…”

The correlation between asthma control and health status: the GOAL study

“…However, the magnitude of the increase and end-of-study values in the present study were high, comparing favourably with values in the Formoterol And Corticosteroids Establishing Therapy (FACET) study [6], which was of similar duration. This is to be expected since the individualised treatment was increased in GOAL with the purpose of achieving the best possible level of control, whereas the FACET study employed only a single fixed dose of treatment and a ''step-down'' study design.…”

“…contrast, in the FACET study an initial large increase in AQLQ score was followed by a gradual decline over the remainder of the 1-yr study period, suggesting gradual loss of control [6].…”

“…However, further improvement in AQLQ score was observed throughout the remainder of the 52-week study, beyond the point at which patients received no further dose increase in the controller treatment. The plateauing of the values towards the end of the study may reflect the absence of further dose increases and the fact that no further benefit or a ceiling effect [6] was being achieved (the limits of efficacy) as more and more patients approached maximum scores. By …”

“…However, a number of studies [6][7][8] have demonstrated poor correlation between conventional clinical indices and the outcomes of the Asthma Quality of Life Questionnaire (AQLQ). Conversely, studies that have used more comprehensive measures of overall asthma control have found that achieving asthma control translates into significant improvements in AQLQ score [9,10].…”