Status:
COMPLETED
Effects of Ciclesonide MDI 50mg/Day and 200mg/Day (Ex-Valve) Once-Daily on Growth in Children With Mild Persistent Asthma
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Takeda
Conditions:
Asthma
Eligibility:
All Genders
5-102 years
Phase:
PHASE3
Brief Summary
The primary objective is to determine if CIC 50 mg/day or 200 mg/day (ex-valve) administered once daily in the morning is non-inferior to placebo with respect to growth velocity in children with mild ...
Eligibility Criteria
Inclusion
- Females between 5 and 7.5 years and male between 5 and 8.5 years of age with normal heights, a history of mild persistent asthma for at least 3 months prior to visit 1, a forced expiratory volume in one second (FEV1) of ³80% of predicted following at least a 4-hour albuterol withhold, and treated with non-corticosteroid asthma medications on an as-needed or daily basis, or with low doses of inhaled corticosteroids (ICSs) for at least one month prior to Visit 1. Subjects were to be no greater than Stage 1 in the Tanner classification of sexual maturity, and they had to be able to demonstrate effective use of the MDI devices and perform reproducible pulmonary function test.
Exclusion
- Subjects with a history of life-threatening asthma, severe respiratory impairment, history of abnormal growth, concurrent disease or condition which may substantially affect growth, previous requirement for daily or alternate day oral corticosteroids (OCS) treatment for ³60 days within the 2 years of Visit 3 and/or any use of OCS within 30 days prior to Visit 1 or during the run-in period, previous treatment with moderate or high doses of inhaled corticosteroid during the 30 days prior to Visit 1
Key Trial Info
Start Date :
December 1 2000
Trial Type :
INTERVENTIONAL
End Date :
September 1 2004
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT00270348
Start Date
December 1 2000
End Date
September 1 2004
Last Update
December 28 2005
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.