Effects Of Ciclesonide And Beclomethasone On Lens Opacification In Adult Subjects With Moderate To Severe Persistent Asthma

NCT00254956 | Completed Phase 3

• 1 other identifier: SFY6160
• Study Type: interventional
• Target: 1,568
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Tract Diseases; Respiratory Hypersensitivity; Asthma

Keywords

Diseases; respiratory tract diseases; respiratory hypersensitivity; asthma

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (7)

• - 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).

Interventions

ciclesonide (XRP1526) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or non-pregnant, non-lactating females 18 years of age and older with a history of moderate to severe persistent asthma for a duration of at least 2 months prior to screening.
• At screening, FEV1 must be ≥ 40% and ≤ 85% of predicted.
• Documented use of inhaled corticosteroid therapy at any dose for at least 1 month prior to screening.
• Able to demonstrate acceptable oral inhaler technique.
• Non-smoker for at least the past year and less than a 10 pack-year smoking history if previous smoker.
• Written informed consent agreement.

You may not qualify if:

• History of prior cataract surgery in either eye.
• Evidence of congenital cortical cataract.
• Inability to grade nuclear, cortical, or posterior subcapsular opacities in either eye with LOCS III at the baseline slit lamp examination.
• Inability to dilate pupils to at least 6.0 mm.
• Nuclear opalescence with a LOCS III grade ≥ 4 in either eye at the baseline slit lamp examination.
• Cortical lens opacities with a LOCS III grade ≥ 3 in either eye at the baseline slit lamp examination.
• Posterior subcapsular lens opacities with a LOCS III grade ≥ 2 in either eye at the baseline slit lamp examination.
• Elevated intraocular pressure requiring treatment
• Best corrected visual acuity less than 74 letters (equivalent to vision worse than 20/30) in either eye at baseline.
• Females who are pregnant or lactating or have a positive pregnancy test at Visit 1 (Screening).
• Have had more than 1 in-patient hospitalization in the past year for asthma exacerbations.
• Have had more than 2 bursts of oral steroids per year for each of the past 2 years prior to screening.
• Chronic use of oral, injectable, or topical steroids except for inhaled corticosteroids for any condition. Topical corticosteroids designated as having a mild potency by the Stoughton-Cornell Scale or the European Guideline for levels of corticosteroid activity are allowed (see AppendixG).
• Any chronic condition that is likely to require treatment with oral or systemic corticosteroids other than asthma (e.g. systemic lupus, inflammatory bowel disease, rheumatoid arthritis).
• Topical ocular steroid treatment within 3 months prior to screening.

Sponsors & Collaborators

• Sanofi: lead
• Takeda: collaborator

Study Sites (1)

Sanofi-Aventis

Chilly-Mazarin, 91380, France

Location

Related Publications (1)

• Chylack LT Jr, Gross GN, Pedinoff A; Ciclesonide Lenticular Safety Study Group. A randomized, controlled trial to investigate the effect of ciclesonide and beclomethasone dipropionate on eye lens opacity. J Asthma. 2008 Dec;45(10):893-902. doi: 10.1080/02770900802353636.

  PMID: 19085579 DERIVED

MeSH Terms

Conditions

Respiratory Tract Diseases; Respiratory Hypersensitivity; Asthma; Disease

Interventions

ciclesonide

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• ICD CSD

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 15, 2005
• First Posted: November 17, 2005
• Study Start: January 1, 2004
• Primary Completion: June 1, 2005
• Study Completion: June 1, 2005
• Last Updated: April 8, 2009

Record last verified: 2009-04

Locations

FR (1)