In a study of asthmatic children 5 to 12 years of age, those treated with budesonide administered via a dry powder inhaler 200 mcg twice daily (n=311) had a -centimeter reduction in growth compared with those receiving placebo (n=418) at the end of one year; the difference between these two treatment groups did not increase further over three years of additional treatment. By the end of four years, children treated with the budesonide dry powder inhaler and children treated with placebo had similar growth velocities. Conclusions drawn from this study may be confounded by the unequal use of corticosteroids in the treatment groups and inclusion of data from patients attaining puberty during the course of the study.
Two similar drug trials studied a total of 970 adult patients with active, mild to moderate UC. Each trial consisted of 2 groups: one group was given UCERIS tablets and the other was given sugar pills (placebo). Participants had an Ulcerative Colitis Disease Activity Index (UCDAI) score that was equal to or higher than 4, but less than or equal to 10. UCDAI measures UC with a total score of 0 to 12, based on frequency of bowel movements, rectal bleeding, appearance of the colon, and the physician’s rating of disease activity. Remission was defined as a UCDAI score of less than or equal to 1. 1,4