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

The Formoterol and Corticosteroids Establishing Therapy (FACET) study has p rovided the first opportunity to examine the long-term effects of inhaled s teroids and long-acting beta(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 qualit y of life; 2) to determine whether initial improvements in quality of life are sustained when improvements in clinical indices persist; and 3) to eval uate the long-term relationship between changes in clinical indices and cha nges 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 mu g bud esonide, patients mere randomized to either 200 mu g (Bud200) or 800 mu g b udesonide (Bud800) in combination with either 24 mu g formoterol (F) or pla cebo daily for 1 yr. The Asthma Quality of Life Questionnaire (AQLQ) was co mpleted and conventional clinical indices measured at enrolment and randomi zation and on seven occasions during the following 12 months. During the run-in, there was an improvement in AQLQ score (changes (Delta) in overall score approximate to 0.50; p<0.0001). After randomization, there was a further improvement in the Bud800+F group (Delta=0.21; p=0.028). One month post-randomization, improvements in all groups stabilized and were s ustained throughout the 12 months in a pattern very similar to that observe d for the conventional clinical indices. The correlation of individual pati ent changes in clinical indices and changes in AQLQ score during the 12-mon th randomized period were weak to moderate (maximum r=0.51). Improvements in quality of life, which were greatest in the 800 mu g budeso nide plus 24 mu g formoterol group, were sustained throughout the 12 months in a similar manner to the clinical indices. Long-term changes in conventi onal clinical indices cannot be used to predict the effect of treatment on individual patient experience.