Efficacy and Safety of Ciclesonide (CIC) Administered Twice Daily in Pediatric Patients With Asthma.
- Registration Number
- NCT00392288
- Lead Sponsor
- AstraZeneca
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 528
- History of persistent bronchial asthma for at least 3 months prior to screening;
- For patients with persistent bronchial asthma and being treated with a controller therapy: Documented use of an inhaled steroid or Singulair® 5mg once daily;
- For patients with persistent bronchial asthma and not being treated with controller therapy: Patients may have documented use of a reliever therapy such as albuterol/salbutamol or may be untreated;
- Morning Peak Expiratory Flow (AM PEF) of ≤90% of predicted values from the in-clinic spirometry after a 6 hour withhold of albuterol/salbutamol;
- Only patients aged between 6 to <12 years must have a forced expiratory volume in one second (FEV1) of ≥50% to ≤85% of predicted normal after a 6 hour withhold of albuterol/salbutamol
- Nocturnal awakenings for asthma which require treatment with albuterol/salbutamol for 4 or more nights out of the last 7 days of the screening period;
- Use of more than 8 puffs/day of albuterol/salbutamol on 3 or more consecutive days within the last 7
- Upper or lower respiratory tract infection within 4 weeks prior to screening and during screening period;
- History of life-threatening asthma, including a history of significant hypercarbia (pCO2 >45 mmHg), prior intubation, respiratory arrest, or seizures as a result of an exacerbation of asthma;
- More than 3 in-patient hospitalization or emergency care visits due to asthma exacerbations in the year prior to screening;
- Use of injectable or oral corticosteroids within one month prior to screening, or more than 3 bursts) within 6 months prior to screening;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo MDI Placebo double-blind Ciclesonide MDI 40 µg BID Ciclesonide double-blind Ciclesonide MDI 80 µg BID Ciclesonide double-blind
- Primary Outcome Measures
Name Time Method Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 12. 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Total Daily Asthma Symptom Score at Week 12. 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. Baseline and Week 12 Change in albuterol/salbutamol use from baseline to week 12
Trial Locations
- Locations (6)
Sanofi-Aventis
🇲🇽Mexico, Mexico
sanofi-aventis Poland
🇵🇱Warszawa, Poland
Sanofi-Aventis Hungaria
🇭🇺Budapest, Hungary
sanofi-aventis South Africa
🇿🇦Midrand, South Africa
sanofi-aventis, US
🇺🇸Bridgewater, New Jersey, United States
Sanofi-Aventis Administrative Office
🇷🇺Moscow, Russian Federation