Status:
WITHDRAWN
Inhaled Fluticasone Propionate: Effect on Parameters of Bone Metabolism in Patients With Mild to Moderate Asthma
Lead Sponsor:
University of Kansas
Collaborating Sponsors:
Sanofi
Conditions:
Asthma
Eligibility:
All Genders
20-45 years
Phase:
NA
Brief 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 wi...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00409630
Last Update
April 12 2012
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