Original ArticlePotential Effects of Fluticasone Propionate on Bone Mineral Density in Patients With Asthma: A 2-Year Randomized, Double-Blind, Placebo-Controlled Trial
Section snippets
Procedures
This multicenter randomized, double-blind, parallelgroup trial (conducted from July 1994 through June 1997) evaluated the safety of 2 doses (88 µg and 440 µg) of fluticasone administered twice daily with use of a chlorofluorocarbon metered dose inhaler without a spacer device vs placebo for 104 weeks in 160 adult patients with mild asthma (mean forced expiratory volume in 1 second [FEV1] of 82%-85% predicted). Blinded labels (based on a randomization code generated by a statistician at the
Disposition and Demographics
Of the 190 patients screened (ie, entered the 21-day single-blind placebo run-in period), 30 did not meet screening criteria (including 4 with BMD below the limits established for young healthy controls); thus, 160 patients were randomized to treatment (Table 2) in groups balanced across 5 demographic characteristics. More patients in the fluticasone-treated groups compared with the placebo group withdrew from the study. Withdrawals because of adverse events considered at least possibly related
DISCUSSION
The results of this placebo-controlled study in which patients with mild asthma and minimal prior systemic corticosteroid exposure used aerosol fluticasone at 88 µg or 440 µg twice daily (highest recommended dosage for patients not requiring prednisone) for 2 years show that long-term treatment with either dose of fluticasone was comparable to placebo in all assessments of skeletal and ophthalmic function. Treatment with high-dose fluticasone (440 µg twice daily) was associated with a
CONCLUSION
Twice-daily treatment with fluticasone at 88 µg and 440 µg (the highest recommended dose for patients not requiring prednisone) for up to 2 years was well tolerated in adults with mild asthma. Fluticasone at 88 µg had effects comparable to those of placebo on HPA axis function, the skeleton, and the eyes. Fluticasone at 440 µg had minor, transient effects on HPA axis function, consistent with observed effects in studies of shorter duration, but no statistically significant effects on BMD at the
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This study was funded by GlaxoSmithKline, Research Triangle Park, NC.
Results of this study were presented at the World Asthma meeting, Chicago, Ill, July 12-15, 2001; the American Thoracic Society meeting, Chicago, Ill, April 25-28, 1998; and the American Society of Bone and Mineral Research meeting, San Francisco, Calif, December 3-6, 1998.
For editorial comment, see page 453.