Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00262405
Status:
COMPLETED
Last Update Posted:
2015-12-03
First Post:
2005-09-12
Brief Title:
Zileuton for the Treatment of Idiopathic Pulmonary Fibrosis
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
Phase II Trial of Zileuton Compared to AzathioprinePrednisone for the Treatment of Idiopathic Pulmonary Fibrosis
Status:
COMPLETED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Open label trial of zileuton compared to azathioprineprednisone for patients with idiopathic pulmonary fibrosis Study subjects will undergo a detailed clinical radiographic and physiologic assessment at baseline Subjects will be monitored off treatment for three months for changes in symptoms and physiology Subjects will then be randomized to six months of treatment with zileuton or azathioprineprednisone The primary endpoint of this trial is change in LTB4 levels in bronchoalveolar lavage fluid following six months of treatment Secondary endpoints are progression free survival change in dyspnea change in quality of life and change in physiology
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P50HL056402-06 | NIH | None | httpsreporternihgovquickSearchP50HL056402-06 |