Data Show Alvesco Improves Quality of Life for Asthma Patients
Researchers have concluded that treatment taken once a day with the investigational therapy Alvesco significantly improves quality of life compared to placebo in patients with mild-to-moderate asthma.
Alvesco (ciclesonide) is an inhaled corticosteroid with novel release and distribution properties. Inhaled corticosteroids, considered to be the foundation of asthma treatment, work by reducing inflammation in the lungs and airways. The effect of ciclesonide on quality of life was evaluated in an integrated analysis of two identical Phase III, 12-week, multicenter, double-blind, randomized, placebo-controlled, parallel-group clinical trials.
A total of 1,015 patients with mild-to-moderate asthma were randomized to receive placebo or ciclesonide (CIC) 80 mcg, 160 mcg or 320 mcg once daily. Quality of life was assessed using the overall score from the Juniper Asthma Quality-of-Life Questionnaire (AQLQ) and individual domain scores (activity limitation, symptoms, emotional function and exposure to environmental stimuli) were recorded at baseline and at four and 12 weeks.
A minimally important difference (MID) of greater than or equal to 0.5 was required for each domain or overall AQLQ score to reflect clinically important changes in quality of life. A significant improvement in the overall AQLQ score was observed for all CIC groups versus placebo, from baseline to Week 12. A similar trend was observed for all four individual domain scores, except the environmental stimuli domain in the CIC80 group. A change from baseline to Week 12 in overall AQLQ score of greater than or equal to 0.5 MID was noted in a greater proportion of patients in the CIC groups versus placebo.