Efficacy and Safety of Ciclesonide (CIC) Administered Twice Daily in Pediatric Patients With Asthma.
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|ClinicalTrials.gov Identifier: NCT00392288|
Recruitment Status : Completed
First Posted : October 25, 2006
Results First Posted : December 30, 2009
Last Update Posted : February 1, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: Ciclesonide Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||528 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Multicenter, Multi-national, Randomized, Double-blind, Placebo-controlled, Study to Assess the Efficacy and Safety of Ciclesonide Metered-dose Inhaler (MDI) at 80 μg BID or 40 μg BID for 12 Weeks in Patients Aged 4 to <12 Years With Persistent Asthma.|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||February 2008|
|Actual Study Completion Date :||February 2008|
Placebo Comparator: Placebo MDI
Placebo MDI over twelve weeks
Experimental: Ciclesonide MDI 40 µg BID
Ciclesonide MDI 40 µg BID over twelve weeks
Experimental: Ciclesonide MDI 80 µg BID
Ciclesonide MDI 80 µg BID over twelve weeks
- Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 12. [ Time Frame: Baseline and 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.
- Change From Baseline in Total Daily Asthma Symptom Score at Week 12. [ Time Frame: Baseline and 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)
- Change From Baseline in Use of Albuterol/Salbutamol at Week 12. [ Time Frame: Baseline and Week 12 ]Change in albuterol/salbutamol use from baseline to week 12
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00392288
|United States, New Jersey|
|Bridgewater, New Jersey, United States, 08807|
|Sanofi-Aventis Administrative Office|
|Moscow, Russian Federation|
|sanofi-aventis South Africa|
|Midrand, South Africa|
|Study Director:||AstraZeneca AstraZeneca||AstraZeneca|