Efficacy and safety of three ciclesonide doses vs placebo in children with asthma: the RAINBOW study.

OBJECTIVE: To evaluate the efficacy and safety of three doses of ciclesonide (with or without spacer) in children with persistent asthma. PATIENTS AND METHODS: This was a multicentre, double-blind, placebo-controlled, 12-week study of ciclesonide 40, 80 or 160 µg (once daily pm). Children (6-11 years) were randomised 1:1 to treatment via a metered dose inhaler (MDI) or MDI plus spacer. The primary variable was change from baseline in mean morning peak expiratory flow (PEF). Secondary variables included: time to first lack of efficacy (LOE), asthma control, forced expiratory volume in 1 s (FEV(1)), asthma symptom score and quality of life (QoL). Safety assessments included: adverse events (AEs), urinary cortisol excretion and body height. RESULTS: In total, 1073 children received treatment. At endpoint, mean morning PEF significantly improved with all doses of ciclesonide vs. placebo. There was no difference over placebo in time to first LOE, but ciclesonide was superior to placebo on asthma control, symptom score, FEV(1) and QoL. There were no differences between the spacer or non-spacer subgroups. The incidences of AEs were comparable between treatment groups (approximately 35%) and there were no between-group differences in body height or urinary cortisol. CONCLUSIONS: Ciclesonide 40-160 µg once daily is effective and well tolerated in children with persistent asthma; its efficacy and safety are unaffected by the use of a spacer. clinicaltrials.gov registration number: NCT00384189.

Hypoglycemia anticipation, awareness and treatment training (HAATT) reduces occurrence of severe hypoglycemia among adults with type 1 diabetes mellitus.

Severe hypoglycemia (SH) can be a significant problem for patients around the world with Type 1 Diabetes Mellitus (T1DM). To avoid SH, patients need to better manage, and reduce the occurrence of, preceding mild hypoglycemia. Hypoglycemia Anticipation, Awareness and Treatment Training (HAATT), developed in the United States specifically to address such issues, was evaluated at short- and long-term follow-up in a medically, economically and culturally different setting; Bulgaria. Sixty adults with T1DM and a history of recurrent SH (20 each from Sofia, Russe, and Varna, Bulgaria) were randomized to Self-Monitoring of Blood Glucose (SMBG) or SMBG+ HAATT. For 6 months before and 1 to 6 and 13 to 18 months after intervention, participants recorded occurrence of moderate, severe, and nocturnal hypoglycemia. For 1-month pre- and post-intervention, participants completed daily diaries concerning their diabetes management. Relative to SMBG, HAATT produced significant improvement in occurrence of low BG, moderate, severe, and nocturnal hypoglycemia, and detection and treatment of low BG (p values < .05 to < .001), with no compromise in metabolic control. At long-term follow-up, HAATT participants continued to have significantly fewer episodes of moderate and severe hypoglycemia. These findings suggest that a structured, specialized psycho-educational treatment program (HAATT) can be highly effective in managing hypoglycemia.