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

Sponsor:	University of Kansas
Collaborator:	Sanofi-Aventis
Information provided by:	University of Kansas
ClinicalTrials.gov Identifier:	NCT00409630

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:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics Study
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

Drug Information available for: Fluticasone propionate Fluticasone

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

Estimated Enrollment:

30

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-Aventis

Investigators

Principal Investigator:

Leland Graves, MD

University of Kansas

More Information

No publications provided

Study ID Numbers:	10384
Study First Received:	December 8, 2006
Last Updated:	June 7, 2007
ClinicalTrials.gov Identifier:	NCT00409630 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Kansas:

Asthma

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Bronchial Diseases
Immune System Diseases
Physiological Effects of Drugs
Anti-Asthmatic Agents
Asthma
Anti-Allergic Agents
Pharmacologic Actions
Lung Diseases, Obstructive
Hypersensitivity

Respiratory Tract Diseases
Autonomic Agents
Therapeutic Uses
Lung Diseases
Hypersensitivity, Immediate
Fluticasone
Peripheral Nervous System Agents
Dermatologic Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on February 08, 2010