Abstract
There are still some concerns about the safety of high doses of inhaled glucocorticosteroids (ICS). We compared the safety and efficacy of fluticasone propionate (FP) and beclomethasone dipropionate (BDP) in 306 patients with moderate to severe asthma in a double-blind, multicenter, cross-over study of 12 mo duration. During the 1-mo run-in period, bronchodilators were replaced by salmeterol 50 microg twice daily, increasing morning peak expiratory flow rate (PEFR) by 28 L/min (p < 0.001) and FEV1 by 6.2% predicted (p < 0.001). At randomization the current ICS was replaced by 500 microg BDP or 250 microg FP in accordance with previously taken 500 microg BDP or 400 microg budesonide (BUD). No significant differences between the two treatments regarding morning plasma cortisol, urinary excretion of calcium and hydroxyproline, FEV1, and PEFR were observed at any time point during the study. Osteocalcin and bone mineral density (BMD) were improved over baseline in the FP group, resulting in higher serum osteocalcin levels (mean difference 0.28 ng/ml; p < 0.001) and higher BMD in the spine (1.0%; p = 0.05), femoral neck (1.6; p < 0.01), and Ward's triangle (3.6%; p = 0.01) as compared with BDP. We conclude that chronic treatment with FP, at half the dose of BDP, results in a similar antiasthma effect but a more favorable safety profile with respect to bone metabolism and mineral density.
Publication types
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Clinical Trial
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Comparative Study
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Multicenter Study
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Randomized Controlled Trial
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Research Support, Non-U.S. Gov't
MeSH terms
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Administration, Topical
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Adolescent
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Adrenergic beta-Agonists / administration & dosage
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Adrenergic beta-Agonists / therapeutic use
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Adult
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Aged
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Albuterol / administration & dosage
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Albuterol / analogs & derivatives
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Albuterol / therapeutic use
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Androstadienes / administration & dosage
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Androstadienes / therapeutic use*
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Anti-Asthmatic Agents / administration & dosage
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Anti-Asthmatic Agents / therapeutic use*
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Anti-Inflammatory Agents / administration & dosage
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Anti-Inflammatory Agents / therapeutic use*
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Asthma / drug therapy*
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Beclomethasone / administration & dosage
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Beclomethasone / therapeutic use*
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Belgium
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Bone Density
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Bronchodilator Agents / administration & dosage
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Bronchodilator Agents / therapeutic use
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Budesonide / administration & dosage
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Budesonide / therapeutic use
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Calcium / urine
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Cross-Over Studies
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Double-Blind Method
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Female
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Femur Neck / anatomy & histology
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Femur Neck / metabolism
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Fluticasone
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Forced Expiratory Volume / drug effects
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Humans
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Hydrocortisone / blood
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Hydroxyproline / urine
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Male
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Middle Aged
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Osteocalcin / blood
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Peak Expiratory Flow Rate / drug effects
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Safety
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Salmeterol Xinafoate
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Spine / anatomy & histology
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Spine / metabolism
Substances
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Adrenergic beta-Agonists
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Androstadienes
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Anti-Asthmatic Agents
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Anti-Inflammatory Agents
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Bronchodilator Agents
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Osteocalcin
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Budesonide
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Salmeterol Xinafoate
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Fluticasone
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Beclomethasone
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Albuterol
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Hydroxyproline
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Calcium
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Hydrocortisone