Inhaled Fluticasone Propionate: Effect on Parameters of Bone Metabolism in Patients With Mild to Moderate Asthma
Information source: University of Kansas
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: fluticasone (Drug)
Phase: N/A
Status: Withdrawn
Sponsored by: University of Kansas Official(s) and/or principal investigator(s):
Leland Graves, MD, Principal Investigator, Affiliation: University of Kansas
Summary
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.
Clinical Details
Official title: Inhaled Fluticasone Propionate: Effect on Parameters of Bone Metabolism in Patients With Mild to Moderate Asthma
Study design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics Study
Primary outcome: Bone markers after 3 months of fluticasone
Secondary outcome: Skin thickness measured by ultrasound biomicroscopy
Detailed description:
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.
Eligibility
Minimum age: 20 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Last updated: June 7, 2007
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