Inhaled Fluticasone Propionate: Effect on Parameters of Bone Metabolism in Patients With Mild to Moderate Asthma

Inclusion Criteria:

• Before any study-specific procedure, the appropriate informed consent must be signed
• Male and premenopausal female subjects
• Age ≥ 20 years through ≤ 45 years of age

• Documented History of Mild to moderate Asthma as defined by the NHLBI guidelines:

  • Mild Intermittent - FEV1 or PEF >/= 80% predicted, PEF variability <20%.
  • Mild persistent - FEV1 or PEF >80% predicted, PEF variability, >/= 20-30%
  • Moderate persistent - FEV1 or PEF>60%-<80% predicted, PEF variability >30%
• Ambulatory status

Exclusion Criteria:

• Smoking
• Current use of inhaled glucocorticoid therapy or use within the past 3 months. Current use of leukotriene modifiers and/or inhaled bronchodilators will be allowed.
• Use of oral glucocorticoids within the past year.
• Pregnant or breast feeding.
• Last menstrual period greater than 1 year ago
• Diabetes Mellitus type 1 or 2
• Paget's Disease, osteomalacia, hyperparathyroidism, renal osteodystrophy or other metabolic bone diseases
• History of hyperthyroidism within 1 year of randomization
• AST or ALT > 2x upper limit of normal
• Serum creatinine greater than 2.0 mg/DL
• History of cancer within the previous 5 years, (exceptions: excised superficial lesions, such as basal or squamous cell carcinoma of the skin.
• The use of thiazide diuretics or anticonvulsant medications.
• Subject is currently enrolled or has received investigational drug within 30 days prior to randomization
• Use of (within 3 months of randomization) hormones, SERMS, calcitonin, PTH (Forteo)
• Use of (within 6 months of randomization) bisphosphonates, (Fosamax, Actonel, Didronel), Vitamin D 50,000 iu
• Use of (within 12 months of randomization) corticosteroids and/or inhaled steroids, anticonvulsants. Topical and intra-articular steroids are allowed except for topical steroids applied to the area where measurements of skin thickness will be made; ie.
• Use of (within 24 months of randomization) I.V. Zometa or I.V. Aredia
• Subject has any disorder that compromises the ability of the subject to give written consent and/or to comply with study procedures