Effects Of Ciclesonide And Beclomethasone On Lens Opacification In Adult Subjects With Moderate To Severe Persistent Asthma
|ClinicalTrials.gov Identifier: NCT00254956|
Recruitment Status : Completed
First Posted : November 17, 2005
Last Update Posted : April 8, 2009
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Tract Diseases Respiratory Hypersensitivity Asthma||Drug: ciclesonide (XRP1526)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1568 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Multi-Center, Multinational, Randomized, Double-Blind, Parallel Group Study of the Effects of Ciclesonide Hfa-Mdi 640 μg/Day and Beclomethasone Hfa-Mdi 640 μg/Day on Lens Opacification in Adult Subjects With Moderate to Severe Persistent Asthma|
|Study Start Date :||January 2004|
|Actual Primary Completion Date :||June 2005|
|Actual Study Completion Date :||June 2005|
- The primary endpoint is the occurrence of a Class I lens event for nuclear (NO), cortical (C), or posterior subcapsular (P) lens opacification within 12 months.
- A Class I lens event is defined as any of the following events in either eye:
- - 1.Increase from baseline in LOCS III grade of ≥ 0.5 (NO), ≥ 0.8 (C), or ≥ 0.5 (P)
- - 2.Cataract surgery
- - 1.Change from baseline to Month 12 in LOCS III grade for (a) nuclear opalescence, (b) cortical opacity, and (c) posterior subcapsular opacity.
- - 2.Occurrence within 12 months in either eye of a Class II lens event: Increase from baseline in LOCS III grade of ≥ 0.9 (NO), ≥ 1.5 (C), or ≥ 0.9 (P), or cataract surgery.
- - 3.Occurrence within 12 months in either eye of a Class III lens event: LOCS III grade ≥ 2.0 for any type of opacity (NO, C, or P) and a change in LOCS III grade of ≥ 0.9 for NO, ≥ 1.5 for C, and ≥ 0.9 for P, or cataract surgery.
- - 4.Change from baseline to Month 12 in best-corrected visual acuity.
- - 5.Change from baseline to Month 12 in intraocular pressure (mm Hg).
- Tertiary endpoint:
- - Change in post-bronchodilator FEV1 from baseline to Month 12.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00254956
|Chilly-Mazarin, France, 91380|
|Study Director:||ICD CSD||Sanofi|