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| Sponsor: | Sanofi-Aventis |
|---|---|
| Collaborator: |
ALTANA Pharma |
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00254956 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Respiratory Tract Diseases Respiratory Hypersensitivity Asthma |
Drug: ciclesonide (XRP1526) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
| Enrollment: | 1568 |
| Study Start Date: | January 2004 |
| Study Completion Date: | June 2005 |
| Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
This is a multi-center, multinational, active-controlled, double-blind, randomized (1:1) parallel group study of the effects of inhaled ciclesonide HFA-MDI 640 mcg/day and beclomethasone HFA-MDI 640 mcg/day 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 6.0 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | ICD Study Director, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00254956 History of Changes |
| Other Study ID Numbers: | SFY6160 |
| Study First Received: | November 15, 2005 |
| Last Updated: | April 7, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
Diseases respiratory tract diseases respiratory hypersensitivity asthma |
|
Asthma Hypersensitivity Respiratory Hypersensitivity Respiratory Tract Diseases Bronchial Diseases Lung Diseases, Obstructive Lung Diseases Hypersensitivity, Immediate Immune System Diseases Beclomethasone Ciclesonide |
Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Anti-Allergic Agents |