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Inhaled Fluticasone Propionate: Effect on Parameters of Bone Metabolism in Patients With Mild to Moderate Asthma
This study has been withdrawn prior to enrollment.
(Sponsor decided against going forward with the study.)
Sponsor:
University of Kansas
Collaborator:
Sanofi
Information provided by:
University of Kansas Medical Center
ClinicalTrials.gov Identifier:
NCT00409630
First received: December 8, 2006
Last updated: April 11, 2012
Last verified: April 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
| Asthma | Drug: fluticasone |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Inhaled Fluticasone Propionate: Effect on Parameters of Bone Metabolism in Patients With Mild to Moderate Asthma |
Resource links provided by NLM:
Further study details as provided by University of Kansas Medical Center:
Primary Outcome Measures:
- Bone markers after 3 months of fluticasone
Secondary Outcome Measures:
- Skin thickness measured by ultrasound biomicroscopy
| Enrollment: | 0 |
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| Ages Eligible for Study: | 20 Years to 45 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00409630
Please refer to this study by its ClinicalTrials.gov identifier: NCT00409630
Sponsors and Collaborators
University of Kansas
Sanofi
Investigators
| Principal Investigator: | Leland Graves, MD | University of Kansas Medical Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00409630 History of Changes |
| Other Study ID Numbers: |
10384 |
| Study First Received: | December 8, 2006 |
| Last Updated: | April 11, 2012 |
Keywords provided by University of Kansas Medical Center:
|
Asthma |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on June 27, 2017