Status:
COMPLETED
Effects Of Ciclesonide And Beclomethasone On Lens Opacification In Adult Subjects With Moderate To Severe Persistent Asthma
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Takeda
Conditions:
Respiratory Tract Diseases
Respiratory Hypersensitivity
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 subcapsul...
Detailed Description
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 m...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Chronic or recurrent inflammatory disease in either eye likely to result in visual abnormalities or require treatment with ocular steroids.
- History of drug or alcohol abuse.
- Any clinically significant medical condition that would interfere with the subject's ability to participate in and comply with study protocol.
- Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study.
- Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
- Hypersensitivity to the investigational products or to drugs with similar chemical structures.
- Have been treated with any investigational drug/product within 30 days prior to Visit 1 (Screening).
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2005
Estimated Enrollment :
1568 Patients enrolled
Trial Details
Trial ID
NCT00254956
Start Date
January 1 2004
End Date
June 1 2005
Last Update
April 8 2009
Active Locations (1)
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1
Sanofi-Aventis
Chilly-Mazarin, France, 91380