Table 2.

Ciclesonide comparative efficacy trials

Author/citation	Dosing	Subject characteristics	Treatment duration	Outcome
Knox40, 2007	CIC 160 μg qd; FP 250 μg bid	17–75 y; controlled asthma w/pretreatmenta	2-week baseline w/current ICS, 12 week treatment	CIC and FP had similar FEV1 maintenance and symptom-free days
Lee41, 2004	CIC 160 μg qd; FP 110 μg bid; placebo	mild to moderate asthmatics	separate 4 week treatment arms, separated by 2-week washout w/ salmeterol + montelukast	No difference between groups in methacholine PC20 hyperresponsiveness
Buhl42, 2006	CIC 160 μg qd; FP 88 μg bid	12–74 y; mild to moderate asthma (GINA)	1- to 2-week baseline w/rescue med only; 12-week treatment	CIC and FP similarly improved lung function, symptom scores, and rescue med use. During last 4 weeks, CIC had higher percentage of symptom-free days
Niphadkar44, 2005	CIC 160 μg qd; BUD 200 μg bid	adults w/ FEV1 ≤ 70%, pretreated	12 weeks, 2-week run-in w/BUD 200 μg bid	CIC as effective as BUD at symptom control
Boulet45, 2006	CIC 320 μg qd; BUD 200 μg bid	pretreated, FEV1 inc. ≥ 7% and 65%–90% pred. after run-in	2-week baseline w/ BUD 1600 μg qd, 12-week treatment	CIC qd as effective as BUD bid
Hansel46, 2006	CIC 80 μg qd; CIC 320 μg qd; BUD 200 μg bid	FEV1 50%–90% pred.	12 weeks	CIC and BUD improved FEV1, FVC, and PEF similarly
von Berg47, 2007	CIC 160 μg qd; BUD 400 μg qd	children w/moderate to severe asthma (GINA 1995)	2- to 4-week run-in w/rescue med only, 12 week treatment	CIC and BUD similarly improved FEV1, morning PEF, rescue med use, and QoL scores
Vermeulen48, 2007	CIC 320 μg qd; BUD 800 μg qd	Children 12–17 y w/severe asthma (GINA 1995)	2-week baseline w/BUD 400 μg qd, 12-week treatment	CIC and BUD comparably improved FEV1, FVC, PEF, symptom-free days, and rescue med use
Boulet49, 2007	CIC 320 μg qd; FP 200 μg bid	12–75 y; FEV1 ≥ 80% w/pretreatment, or FEV1 60–80 and pred	1- to 4-week run-in, 12-week treatment	CIC and FP similarly increased FEV1 and resulted in comparable numbers of symptom-free days
Bateman50, 2008	CIC 320 μg bid; FP 330 μg bid	12–75 y; moderate to severe controlled asthma w/pretreatment	2-week baseline w/current ICS, 24-week treatment	CIC and FP maintained FEV1, and improved morning/evening PEF, rescue med use, and QoL scores
Pedersen51, 2006	CIC 80 μg bid; FP 88 μg bid	symptomatic children 6–15 y; FEV1 50%–90% pred	2- to 4-week baseline w/rescue med only; 12-week treatment	CIC and FP similarly improved FEV1, morning/evening PEF, rescue med usage, and reported symptoms

^aPretreatment defined as subjects having daily ICS treatment prior to randomization. All doses noted are ex-actuator.

Abbreviations: BUD, budesonide; CIC, ciclesonide; FP, fluticasone propionate; ICS, inhaled corticosteroids.