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...

In postmenopausal women, PGS does not significantly reduce hot flashes within a 12-week observation period, but further studies are needed to investigate the long-term effect.