Inhaled Fluticasone Propionate: Effect on Parameters of Bone Metabolism in Patients With Mild to Moderate Asthma
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ClinicalTrials.gov Identifier: NCT00409630 |
Recruitment Status :
Withdrawn
(Sponsor decided against going forward with the study.)
First Posted : December 11, 2006
Last Update Posted : April 12, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Asthma | Drug: fluticasone | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Inhaled Fluticasone Propionate: Effect on Parameters of Bone Metabolism in Patients With Mild to Moderate Asthma |
- Bone markers after 3 months of fluticasone
- Skin thickness measured by ultrasound biomicroscopy

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Ages Eligible for Study: | 20 Years to 45 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00409630
Principal Investigator: | Leland Graves, MD | University of Kansas Medical Center |
ClinicalTrials.gov Identifier: | NCT00409630 |
Other Study ID Numbers: |
10384 |
First Posted: | December 11, 2006 Key Record Dates |
Last Update Posted: | April 12, 2012 |
Last Verified: | April 2012 |
Asthma |
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Fluticasone |
Anti-Inflammatory Agents Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Dermatologic Agents Anti-Allergic Agents |