Efficacy and safety of ciclesonide power inhaler in the treatment of mild-moderate bronchial asthma

Abstract

Objective To evaluate the efficacy and safety of ciclesonide (CIC) powder inhaler for the treatment of mild or moderate bronchial asthma (asthma).Methods A multicenter,randomized,double-blind,placebo-controlled clinical trial was conducted.215 patients with mild or moderate asthma were randomly divided into a test group or a control group.The test group received domestic CIC (80 μg bid) for 12 weeks while the control group was given a placebo.Outcome measures:①The primary outcome:FEV1 before and after treatment.The dropout rate due to lack of efficacy.②The secondary outcome:changes were related in asthma symptom score between the two groups (asthma symptom score includes scores during the day and in the evening).Dose of rescue medicine use.The rate of diurnal variation of PEF.③Adverse events.Results After 12 weeks of treatment:①FEV1 of the test group has no significant improvement (P ＞0.05),but FEV1 of the control group was decreased (P ＜0.05),two groups are significantly different(P ＜0.05).②There was statistically significant difference between the two groups in the dropout rate due to lack of efficacy(P ＜0.01),LOE of the test group was lower than the control group,and the dropout time of LOE in the test group was also late.③Asthma symptom score was significantly reduced in the test group(P ＜0.01),while it was increased in control group,two groups are significantly different(P ＜0.01).④The dose of rescue medicine use was reduced in the test group,but there was no statistically significant difference between the two groups(P ＞0.05).⑤The day variation of PEF was reduced in the test group (P ＜0.01),while the control group was increased (P ＞0.05),two groups are significantly different (P ＜0.01).⑥The adverse events were similar in the two groups (P ＞0.05),involving in throat discomfort,hoarseness,sore throat.Conclosions It tends to be modestly effective and safety to use CIC powder inhaler with 80 μg twice a day for mild-moderate asthma,which is worthy to be popularized. Key words: Asthma; Ciclesonide powder inhalation; Validity; Adverse reaction