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. 2016 May-Jun;33(3):272-7.
doi: 10.4103/0970-2113.180803.

A randomized, double-blind study comparing the efficacy and safety of a combination of formoterol and ciclesonide with ciclesonide alone in asthma subjects with moderate-to-severe airflow limitation

Sundeep S Salvi  1 , Abhijit J Vaidya  2 , Rahul R Kodgule  1 , Jaideep A Gogtay  2
Affiliations

A randomized, double-blind study comparing the efficacy and safety of a combination of formoterol and ciclesonide with ciclesonide alone in asthma subjects with moderate-to-severe airflow limitation

Sundeep S Salvi et al. Lung India. 2016 May-Jun.

Abstract

Context: The combination of inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA) is widely used in the treatment of moderate-to-severe asthma uncontrolled by ICS alone.

Aims: To evaluate the efficacy and safety of a new ICS-LABA combination inhaler containing Formoterol (F) and Ciclesonide (C).

Settings and design: A double-blind, double-dummy, parallel group fashion, multi-centric study.

Subjects and methods: A total of 169 asthma patients received Ciclesonide 80 μg once daily during a 4-week run-in period, after which, they were randomized to receive either C (80 μg) or a combination of F (4.5 μg) and C (80 μg) (FC) both delivered through a hydro-fluro-alkane pressurized-metered-dose inhaler as 1 puff twice daily, for 6 weeks.

Statistical analysis used: Inter-group differences were compared using t-test for independent samples at a significance level of 5%.

Results: From baseline, the improvements in forced expiratory volume in 1 s at 1, 3, and 6 weeks was significantly higher in the FC group compared to Group C (110 ml vs. 40 ml, 140 ml vs. 20 ml, and 110 ml vs. 40 ml, respectively, all P < 0.05). From baseline, the improvements in mean morning peak expiratory flow at 1, 3, and 6 weeks was significantly higher in the FC group compared to Group C (17 L/min vs.-3 L/min, 22 L/min vs. 3 L/min, and 30 ml vs. 8 L/min respectively, all P < 0.05). The changes in symptom scores were similar in both the groups. The adverse events in the FC group were not significantly different from those in the C group.

Conclusions: FC provides better improvement than C alone in terms of lung function and symptoms without increased risk of adverse events in asthma patients.

Keywords: Asthma; bronchodilator agents; clinical respiratory medicine; clinical trials.

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Figures

Figure 1
Figure 1
(a) Study design, (b) flow of patients (CONSORT diagram)
Figure 2
Figure 2
Change in mean forced expiratory volume in 1 s from baseline in FC and C group. FC group demonstrated significant improvement in pre-dose peak flow in comparison with C group
Figure 3
Figure 3
Change in mean morning pre-dose peak flow from baseline in FC and C group. FC group demonstrated significant improvement in pre-dose peak flow in comparison with C group
See this image and copyright information in PMC

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