A randomized, controlled trial to investigate the effect of ciclesonide and beclomethasone dipropionate on eye lens opacity

Leo T. Chylack, Gary N. Gross, Andrew Pedinoff, I. Abdullah, C. Andrews, A. Antczak, J. Baker, C. Banov, J. Bardelas, S. Basheda, E. Bateman, G. Bensch, W. Berger, G. Berman, D. Bernstein, A. Bester, M. Blumberg, A. Bodzenta-Lukaszyk, S. Brazinsky, W. BusseE. Campbell, B. Charous, S. Cohen, J. Condemi, D. Cook, J. Corren, J. Craig, C. Daul, A. DeGraff, M. Drehobl, D. Dumont, A. Dymek, D. Elkayam, I. Engelbrecht, C. Falliers, W. Filley, S. Fineman, L. Ford, B. Friedman, L. Fouche, W. Gamel, R. Gaona, S. Gillman, R. Gilman, P. Goldberg, A. Goldsobel, S. Goldstein, R. Gower, Y. Graham, L. Greos, I. Grzelewska-Rzymowska, F. Hampel, J. Harris, D. Harris, D. Hill, S. Horner, M. Ismail, K. Jacobson, G. Journeay, H. Kaiser, E. Kerwin, M. Kowalski, C. LaForce, K. Lampl, E. LeDoux, J. Leflein, R. Levy, M. Lindley, T. Lowdermilk, W. Lumry, B. Majorek-Olechowska, A. Manjra, L. Mansfield, J. Meadows, S. Meltzer, S. Miller, K. Murphy, M. Nadeemullah, R. Nathan, A. Nayak, M. Noonan, J. O'Brien, G. Olson, S. Patel, D. Pearlman, B. Pfuetze, W. Pleskow, B. Prenner, G. Raphael, P. Ratner, N. Rupp, R. Saff, S. Sahn, E. Schenkel, A. Segal, N. Segall, R. Sellman, R. Settipane, A. Sheffer, L. Sher, E. Sher, W. Sinclair, J. Slominski, C. Smith, C. Smith, J. Sotomayor, S. Spangenthal, S. Spector, R. Sveum, M. Tarpay, S. Tilles, A. Wachtel, J. Wald, S. Weakley, J. Weiler, S. Weinstein, M. Welch, S. Wenzel, K. Williams, J. Winder, Y. Yoon, R. Ziering

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish (US)
Pages (from-to)893-902
Number of pages10
JournalJournal of Asthma
Volume45
Issue number10
DOIs
StatePublished - Dec 2008

Keywords

  • Asthma
  • Beclomethasone dipropionate
  • Cataract
  • Ciclesonide
  • Lenticular opacities

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Immunology and Allergy
  • Pulmonary and Respiratory Medicine

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