Primary objective: To demonstrate the efficacy of ciclesonide, compared to placebo, at 80 μg twice daily (BID) or 40 μg BID for 12 weeks in patients with persistent asthma. Secondary objective: To assess the safety and tolerability of ciclesonide.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
528
Ciclesonide MDI 40 µg BID over twelve weeks
Ciclesonide MDI 80 µg BID over twelve weeks
Placebo MDI over twelve weeks
sanofi-aventis, US
Bridgewater, New Jersey, United States
Sanofi-Aventis Hungaria
Budapest, Hungary
Sanofi-Aventis
México, Mexico
sanofi-aventis Poland
Warsaw, Poland
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 12.
Change in FEV1 (Percent of predicted) from baseline to week 12. FEV1 was measured only in children between 6 to \<12 years only. Least Squares Mean were adjusted for Baseline FEV1, age \[yrs\], pooled center, previous corticosteroid therapy and holding chamber.
Time frame: Baseline and Week 12
Change From Baseline in Total Daily Asthma Symptom Score at Week 12.
Change in total daily asthma symptom score from baseline to week 12. 5-Point, ordinal scale specifying patient's experience of symptoms during day and night from 0 (no symptoms) to 4 (symptoms that prevent the patient from engaging in daily activities or sleep)
Time frame: Baseline and Week 12
Change From Baseline in Use of Albuterol/Salbutamol at Week 12.
Change in albuterol/salbutamol use from baseline to week 12
Time frame: Baseline and Week 12
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Sanofi-Aventis Administrative Office
Moscow, Russia
sanofi-aventis South Africa
Midrand, South Africa