Phase 3
Completed N=528
Efficacy and Safety of Ciclesonide (CIC) Administered Twice Daily in Pediatric Patients With Asthma.
Source: ClinicalTrials.gov NCT00392288 ↗Enrolled (actual)
528
Serious AEs
1.2%
Results posted
Dec 2009
Primary outcomePrimary: Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 12. — 5.2; 5.3; 7.7 Percent of predicted FEV1 — p=0.2696
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 12. |
5.2; 5.3; 7.7 | 0.2696 |
| SECONDARY Change From Baseline in Total Daily Asthma Symptom Score at Week 12. |
-0.96; -1.13; -0.99 | — |
| SECONDARY Change From Baseline in Use of Albuterol/Salbutamol at Week 12. |
-0.59; -0.87; -0.93 | — |
Eligibility Criteria
Inclusion Criteria
- 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 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;
Data sourced from ClinicalTrials.gov (NCT00392288). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.