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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
A randomized, controlled trial to investigate the effect of ciclesonide and beclomethasone dipropionate on eye lens opacity
Journal of Asthma, Volume 45, No. 10, Year 2008
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Description
Background. Inhaled corticosteroids (ICS) are recommended first-line therapy for the treatment of persistent asthma. However, reports from observational studies have suggested that the use of ICS may be associated with systemic adverse events, such as glaucoma and cataract (opacity of the lens) formation. Objective. To compare two ICS over 1 year regarding the formation/progression of lenticular opacities in patients with asthma. Methods. Adults (≥ 18 years of age) with moderate-to-severe asthma were randomized to ciclesonide 640 μg/day (n = 785) or beclomethasone dipropionate 640 μg/day (n = 783) in a multinational, double-blind, active-controlled, parallel-group study. The primary endpoint was the occurrence of a positive Class I grading shift (increase [worsening] in Lens Opacities Classification System [LOCS] III score of ≥ 0.5 for nuclear opalescence, ≥ 0.8 for cortical opacification, or ≥ 0.5 for posterior subcapsular opacification, or cataract surgery) in either eye at any visit over the 12-month, double-blind treatment period. Results. Mean changes (± standard error) in nuclear opalescence and cortical and posterior subcapsular opacification were small and similar between groups (ciclesonide 640 μg/day: 0.10 ± 0.02, 0.07 ± 0.02 and 0.04 ± 0.01, respectively; beclomethasone dipropionate 640 μg/day: 0.11 ± 0.02, 0.09 ± 0.02 and 0.03 ± 0.01, respectively). Class I shifts were observed in 34.3% versus 36.8% of ciclesonide-treated and beclomethasone dipropionate-treated patients, respectively. Ciclesonide 640 μg/day was non-inferior to beclomethasone dipropionate 640 μg/day regarding Class I shifts (risk ratio of ciclesonide to beclomethasone dipropionate, 0.940 [95% confidence interval, 0.820-1.077]); the 95% confidence interval upper bound was lower than the pre-specified non-inferiority bound of 1.333 (p < 0.0001), thereby excluding the possibility of higher risk ratio values. Conclusions. Mean changes in LOCS III scores were very small in both groups. Treatment with ciclesonide 640 μg/day or beclomethasone dipropionate 640 μg/day for 1 year has a minimal impact on lenticular opacities development and/or progression. Copyright © 2008 Informa Healthcare USA, Inc.
Authors & Co-Authors
Bateman, E. D.
Unknown Affiliation
Berman, Gary D.
Unknown Affiliation
Bernstein, David Isaac
Unknown Affiliation
Bester, Anelle M.
Unknown Affiliation
Busse, William Walter
Unknown Affiliation
Craig, Jamie Evan
Unknown Affiliation
Dymek, Andrzej
Unknown Affiliation
Fineman, Stanley M.
Unknown Affiliation
Fouche, Leon Frederik
Unknown Affiliation
Gower, Richard Glen
Unknown Affiliation
Kerwin, Edward M.
Unknown Affiliation
Kowalski, Marek Leszek
Unknown Affiliation
LaForce, Craig F.
Unknown Affiliation
Levy, Robyn J.
Unknown Affiliation
Lumry, William Raymond
Unknown Affiliation
Manjra, Ahmed Ismail
Unknown Affiliation
Miller, S. David
Unknown Affiliation
Murphy, Kevin R.
Unknown Affiliation
O'Brien, John A.
Unknown Affiliation
Weinstein, Steven F.
Unknown Affiliation
Welch, Michael J.
Unknown Affiliation
Wenzel, Sally E.
Unknown Affiliation
Statistics
Citations: 13
Authors: 22
Affiliations: 2
Identifiers
Doi:
10.1080/02770900802353636
ISSN:
15324303
Research Areas
Cancer
Disability
Health System And Policy