Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00254956
Status:
COMPLETED
Last Update Posted:
2009-04-08
First Post:
2005-11-15
Brief Title:
Effects Of Ciclesonide And Beclomethasone On Lens Opacification In Adult Subjects With Moderate To Severe Persistent Asthma
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Multi-Center Multinational Randomized Double-Blind Parallel Group Study of the Effects of Ciclesonide Hfa-Mdi 640 μgDay and Beclomethasone Hfa-Mdi 640 μgDay on Lens Opacification in Adult Subjects With Moderate to Severe Persistent Asthma
Status:
COMPLETED
Status Verified Date:
2009-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective is to demonstrate the non-inferiority of ciclesonide compared to beclomethasone-HFA in the occurrence of Class 1 lens event for nuclear NO cortical C or posterior subcapsular P lens opacification within 12 months Secondary objectives are to compare ciclesonide and beclomethasone with respect to class II and class III best corrected visual acuity and intraocular pressure from baseline to 12 months
Detailed Description:
This is a multi-center multinational active-controlled double-blind randomized 11 parallel group study of the effects of inhaled ciclesonide HFA-MDI 640 mcgday and beclomethasone HFA-MDI 640 mcgday on lens opacification in adult subjects with moderate to severe persistent asthma The study consists of a 1-14 day screening phase during which subject eligibility will be determined followed by a 12-month double-blind treatment phase Lens opacification will be evaluated by slit lamp examination performed after pupillary dilation to at least 60 mm before randomization and after 4 months 8 months and 12 months of treatment using the LOCS III system for grading lens opacities Best-corrected visual acuity and intraocular pressure will be measured at each eye examination visit An Independent Data Monitoring Committee IDMC will be constituted to monitor safety throughout the double-blind treatment phase
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None