Table 7

Efficacy outcomes in trials of ciclesonide compared with placebo

Study
Sample size
Duration
Mean age
% female
InterventionsChange from baseline in total symptom score (TNSS)aPhysician-rated global evaluation of improvementChange in RQLQ; point reductions
Ratner, 2006a
N=726
2 weeks
40 years
71%
female
Ciclesonide 25 μg/day - 200 μg/day compared with placeboCiclesonide 25 μg/day:
−4.8 (sum baseline score: 18.72)
Ciclesonide 50 μg/day:
−4.8 (sum baseline score: 18.35
Ciclesonide 100 μg/day:
−5.3 (sum baseline score: 18.71)
P=0.04 compared with placebo
Ciclesonide 200 μg/day:
−5.8 (sum baseline score 18.82)
P=0.003 compared with placebo

Placebo: −4.2 (sum baseline score 17.80)
Reported as 'somewhat better' than placebo for 100 and 200 μg/day dosesNR
Ratner, 2006b
N=327
4 weeks
40 years
75%
female
Ciclesonide
200 μg/day compared with placebo
Ciclesonide 200 μg/day:
−2.40 (mean baseline score 8.96)
P<0.001 compared with placebo

Placebo:
−1.50 (mean baseline score 8.83)
Change in PANS:
Ciclesonide 200
μg/day:
−1.69 (SE 0.15)
Placebo:
−0.92 (SE 0.15);
P <0.001
Ciclesonide 200
μg/day:
−1.39; P=0.244 compared with placebo

Placebo: −1.21
a

The primary outcome in both trials was the mean change in reflective TNSS at day 14. Ratner 2006a used the sum of morning and evening scores as a baseline measurement, while Ratner 2006b used the mean of morning and evening scores as a baseline measurement.

From: Results

Cover of Drug Class Review: Nasal Corticosteroids
Drug Class Review: Nasal Corticosteroids: Final Report Update 1 [Internet].
Selover D, Dana T, Smith C, et al.
Portland (OR): Oregon Health & Science University; 2008 Jun.
Copyright © 2008, Oregon Health & Science University, Portland, Oregon.

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