Effects Of Ciclesonide And Beclomethasone On Lens Opacification In Adult Subjects With Moderate To Severe Persistent Asthma
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00254956
|Chilly-Mazarin, France, 91380|
|Study Director:||ICD CSD||Sanofi|