Inhaled Fluticasone Propionate: Effect on Parameters of Bone Metabolism in Patients With Mild to Moderate Asthma

NCT00409630 | Withdrawn

• 1 other identifier: 10384
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Asthma

Keywords

Asthma

Outcome Measures

Primary Outcomes (1)

• Bone markers after 3 months of fluticasone

Secondary Outcomes (1)

• Skin thickness measured by ultrasound biomicroscopy

Interventions

fluticasone DRUG

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas: lead
• Sanofi: collaborator

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Leland Graves, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 8, 2006
• First Posted: December 11, 2006
• Last Updated: April 12, 2012

Record last verified: 2012-04