Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00409630
Status:
WITHDRAWN
Last Update Posted:
2012-04-12
First Post:
2006-12-08
Brief Title:
Inhaled Fluticasone Propionate Effect on Parameters of Bone Metabolism in Patients With Mild to Moderate Asthma
Sponsor:
University of Kansas
Organization:
University of Kansas Medical Center
Study Overview
Official Title:
Inhaled Fluticasone Propionate Effect on Parameters of Bone Metabolism in Patients With Mild to Moderate Asthma
Status:
WITHDRAWN
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decided against going forward with the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Calciumcreatinine and adverse events
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None