Profile of ciclesonide for the maintenance treatment of asthma

Figures & data

Table 1 A representative sample of trials evaluating the efficacy of ciclesonide (CIC) in the treatment of asthma in adults and adolescents

Trial	Study design (n of patients)	Pulmonary function	Asthma symptom score	Rescue medication use
Chapman et al^Citation21	12 wk, DB, R, PG, PC, 329 pts, CIC 160, CIC 640, vs PL	PEF and FEV1 did not change with either CIC dosea, decreased with PL	Worsened with PL, stable with either CICa dose	Increased in PL vs both CIC groupsa,b
Adachi et al^Citation22	8 wk, PC, DB, PG, CIC 80 (78), CIC 160 (71), CIC 320 (83), vs PL (79)	PEF did not change with any CIC dose, decreased with PLa	Worsened with PL, stable with all CIC doses	Decreased in all CIC groups vs PL
Langdon et al^Citation23	12 wk, R, PC, CIC 80 (120), 320 (115), vs PL (125)	PEF maintained in CIC groups, decreased in PLa FEV1 increased in CIC groups,a,c slight decrease in PL (P = 0.54)	Worsened with PL, stable with all CIC dosesa	Stable in CIC groups, increased in PL
Pearlman et al^Citation24	12 wk, MC, DB, R, PG, PC, CIC 80 (257), CIC 160 (250), CIC 320 (255), PL (249)	FEV1 and PEF improved in all CIC groups vs PL	Improved with all CIC groups vs PL	Reduced in CIC groups, increased in PL
Berger et al^Citation25	16 wk, MC, MN, DB, PG, PC, R, CIC 80 BID (170), CIC 160 QD (173), CIC 80 BID/CIC 160 QD (171) PL (177)	FEV1 improved in all CIC groups, greatest improvement in CIC 80 BID. AM PEF improved in all CIC groupsa vs PL	Improved in all Rx groups, CIC 80 groups improved vs PL	Decreased in all treatment groups, greatest reduction in CIC groups

Abbreviations: DB, double blind; R, randomized; PG, parallel group; PC, placebo controlled; MC, multicenter; MN, multinational; AM, morning; PL, placebo; wk, week.

a Notes: No significant difference between CIC groups;

b no change from baseline;

c versus baseline;

only statistically significant differences are reported to P < 0.05, unless otherwise noted; all reported doses are exactuator and in micrograms; all medication was delivered via hydrofluoroalkane metered dose inhaler; there were no significant adverse events noted in any of the studies.

Table 2 A representative sample of trials comparing the efficacy and safety of ciclesonide (CIC) to other inhaled corticosteroids

Trial	Study design (number of patients)	Pulmonary function	Asthma symptom score	Rescue medication use
Buhl et al^Citation28	12 wk, MC, R, DB, DD, PG study CIC 160 qd (266)b vs FP 88 BID (263)b	PEF and FEV1 improved significantly in both groupsa	Improved in both treatment groups	Not different between treatment groups
Magnussen et al^Citation29	12 wk, DB, DD, PG, R, CIC 80 qd (278)b, CIC 160 qd (271)b or FP 88 BID (259)b	FEV1 improved significantly in all Rx groupsa Site measured PEF improved significantly in all Rx groups	Improved in all treatment groupsa	Decreased to similar extent in all treatment groupsa
Boulet et al^Citation30	12 wk, R, OL, PG, CIC 320 qd (234)b, FP 200 BID (240)c	FEV1 improved significantly in both Rx groupsa AM PEF improved significantly in CIC group	Improved in both groupsa	Decreased in both treatment groupsa
Bateman et al^Citation31	24 wk, R, MC, OL, PG, CIC 320 BID (255)b, FP 330 BID (273)b	FEV1 maintained in both Rx groupsg PEF improved significantly in both Rx groupsa	Improved in both Rx groupsa	Decreased in both Rx groups
Niphadkar et al^Citation32	12 wk, R, MC, PG, DB, DD, of CIC with OL BUD BID, CIC 160 QAM (139)b, CIC 160 QPM (131)b or BUD 200 BID (133)b	FEV1 maintained in all Rx groupsa No significant differences found among Rx groups for PEF	Maintained in all Rx groupsa	Maintained in all Rx groups vs baselinea
Hansel et al^Citation33	12 wk, MC, R, DB for CIC, OL for BUD, of CIC 80 qd (182)b, CIC 320 qd (195)b vs BUD 200 BID (177)f	FEV1 improved in all groups at 12 wks. No significant difference between CIC groups. PEF improved in all groupsa	Improved in all Rx groups	Decreased in all groups
Boulet et al^Citation34	12 wk MC, R, DB, DD, PG study, CIC 320 qd (179)b, vs BUD 320 qd (180)d	Change in FEV1 was similar in both Rx groups. Mean PEF did not change in either Rx group	No significant difference in scores between Rx groups	Decreased in CIC group
Ukena et al^Citation35	12 wk DB, DD, R, PG study, CIC 320 qd (198)b vs BUD 400 qd (201)d	FEV1 improved in both Rx groups, CIC demonstrating superiority over BUD. PEF improved in both Rx groups, CIC showed greater increase than BUD	Improved in both Rx groupsa	Decreased in both Rx groupsa
Vermeulen et al^Citation36	12 wk MC, R, DB, DD, PG, CIC 320 qdb (272) vs BUD 800 qd (131)d	FEV1 increased in both Rx groups.a AM and PM PEF increased significantly only in CIC group.	Improved in both Rx groupsa	Decreased in both Rx groups

Notes: Only statistically significant differences are reported to P < 0.05, unless otherwise noted; all reported doses are ex-actuator and in micrograms;

a no statistically significant difference noted between the treatment groups;

b delivered via HFA-M;

c delivered dry powder via inhaler (diskus);

d delivered via Turbohaler;

f delivered via dry powder inhaler;

g no significant change seen from baseline to study end.

Abbreviations: AM, morning; DB, double blind; DD, double dummy; R, randomized; PG, parallel group; PC, placebo controlled; MC, multicenter; OL, open label; CIC, Ciclesonide; FP, Fluticasone propionate; BUD, Budesonide; AE, adverse event; wk, week; Rx, treatment; qd, once-daily; BID, twice-daily; vs, versus; QAM, every morning; QPM, every evening; PEF, peak expiratory flow; FEV₁, forced expired volume in one second.

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