Inhaled Fluticasone Propionate: Effect on Parameters of Bone Metabolism in Patients With Mild to Moderate Asthma
Inhaled Fluticasone Propionate: Effect on Parameters of Bone Metabolism in Patients With Mild to Moderate Asthma
Subjects between the ages of 20-45 with mild to moderate asthma will be recruited. Following
 consent, subjects will undergo an evaluation to assure no underlying metabolic bone disease.
 Individuals will be treated with inhaled fluticasone low or high dose, daily for 3 months.
 Serum and urine biochemical markers of bone metabolism will be collected at baseline and
 monthly for three months. Adherence to study medication and adverse events will be collected
 at monthly intervals. Differences between fluticasone low and high dose treated individuals
 will be analyzed between groups and compared with baseline values.
This study will be a prospective randomized trial. Thirty subjects with mild to moderate
 asthma will receive inhaled fluticasone propionate. Fifteen patients will receive low dose
 inhaled fluticasone 88 mcg twice daily. Fifteen patients will receive inhaled fluticasone 440
 mcg twice daily. The primary outcome will be biochemical markers of bone turnover. These will
 include 1) serum biochemical markers of bone formation [osteocalcin, bone specific alkaline
 phosphatase (ALP) and procollagen I C-terminal propeptide (PICP)] and 2) markers of bone
 resorption, serum collagen type 1 C-Telopeptide (CTx) urinary N-telopeptide (NTx) and
 immunoreactive free deoxypyridinoline (iFDpd)]. Secondary endpoints will include, parathyroid
 hormone (PTH), Urinary Calcium/creatinine, and adverse events.
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