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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00409630
• Other study ID #: 10384
• Status: Withdrawn
• Phase: N/A
• First received: December 8, 2006
• Last updated: April 11, 2012

Study information

• Verified date: April 2012
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• fluticasone

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	Sanofi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone markers after 3 months of fluticasone
Secondary	Skin thickness measured by ultrasound biomicroscopy