Dataset Information

Control of moderate-to-severe asthma with randomized ciclesonide doses of 160, 320 and 640 μg/day.

ABSTRACT:

Background

The inhaled corticoteroid (ICS) ciclesonide (Cic), controls asthma symptoms in the majority of patients at the recommended dose of 160 µg/day. However, the relationship between the level of asthma control and increasing doses of Cic is unknown. This study investigated whether long-term treatment with higher doses of Cic would further improve asthma symptoms in patients with uncontrolled asthma despite ICS use.

Patients and methods

In a double-blind, randomized, parallel-group study, 367 patients were allocated to one of three treatment arms (Cic 160, 320 and 640 µg/day). After a single-blind, 3-week baseline period with Cic 160 µg/day, eligible patients were randomized to receive 52 weeks of treatment with Cic 160, 320 or 640 µg/day (double-blind period) during which forced expiratory volume in 1 second (FEV₁), exacerbations and Asthma Control Questionnaire (ACQ) scores were measured.

Results

Treatment with all the three doses was associated with significant improvements in ACQ scores, FEV₁ and asthma symptoms (P<0.01). There were no statistically significant differences between the three doses. The results of the primary end point analysis showed a numerical improvement in the ACQ score with Cic 640 µg/day compared with Cic 160 µg/day (least square [LS] mean: -0.122; two-sided P-value: 0.30). Post hoc subgroup analyses showed that the improvement in the ACQ score with Cic 640 µg/day compared with Cic 160 µg/day was statistically significant in subjects who experience at least one exacerbation per year (LS mean: -0.586; 95% confidence interval: -1.110, -0.062, P=0.0285). Adverse events were low and consistent with the known safety profile of Cic.

Conclusion

In patients with persistent, uncontrolled asthma, increasing the Cic dose from 160 to 640 µg/day provided no clear additional effect. Patients who experience more than one exacerbation per year may benefit from higher doses; however, further studies are necessary to confirm this. All Cic doses were well tolerated.

SUBMITTER: Pedersen SE

PROVIDER: S-EPMC5349703 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Control of moderate-to-severe asthma with randomized ciclesonide doses of 160, 320 and 640 μg/day.

Pedersen Søren E SE Prasad Niyati N Goehring Udo-Michael UM Andersson Henrik H Postma Dirkje S DS

Journal of asthma and allergy 20170307

<h4>Background</h4>The inhaled corticoteroid (ICS) ciclesonide (Cic), controls asthma symptoms in the majority of patients at the recommended dose of 160 µg/day. However, the relationship between the level of asthma control and increasing doses of Cic is unknown. This study investigated whether long-term treatment with higher doses of Cic would further improve asthma symptoms in patients with uncontrolled asthma despite ICS use.<h4>Patients and methods</h4>In a double-blind, randomized, parallel ...[more]

PMID: 28331346

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Dataset Information

Control of moderate-to-severe asthma with randomized ciclesonide doses of 160, 320 and 640 μg/day.

Background

Patients and methods

Results

Conclusion

Publications

Control of moderate-to-severe asthma with randomized ciclesonide doses of 160, 320 and 640 μg/day.

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