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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This study has been withdrawn prior to enrollment.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:
Collaborator:
Sanofi
Information provided by:
University of Kansas
ClinicalTrials.gov Identifier:
NCT00409630
First received: December 8, 2006
Last updated: April 11, 2012
Last verified: April 2012
History of Changes
  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
Endpoint Classification: Pharmacokinetics Study
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:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Bone markers after 3 months of fluticasone

Secondary Outcome Measures:
  • Skin thickness measured by ultrasound biomicroscopy

Enrollment: 0
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

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
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
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00409630     History of Changes
Other Study ID Numbers: 10384
Study First Received: December 8, 2006
Last Updated: April 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
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
Bronchodilator Agents
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 21, 2013