Status:
COMPLETED
Efficacy and Safety of Ciclesonide (CIC) Administered Twice Daily in Pediatric Patients With Asthma.
Lead Sponsor:
AstraZeneca
Conditions:
Asthma
Eligibility:
All Genders
4-11 years
Phase:
PHASE3
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 as...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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;
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
528 Patients enrolled
Trial Details
Trial ID
NCT00392288
Start Date
September 1 2006
End Date
February 1 2008
Last Update
February 1 2017
Active Locations (6)
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1
sanofi-aventis, US
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis Hungaria
Budapest, Hungary
3
Sanofi-Aventis
México, Mexico
4
sanofi-aventis Poland
Warsaw, Poland