Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-03-01 @ 9:58 AM
Study NCT ID:
NCT02487394
Status:
TERMINATED
Last Update Posted:
2023-04-18
First Post:
2015-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Protein Biomarker Discovery and Validation in Chronic Obstructive Pulmonary Disease (COPD) And Asthma
Sponsor:
The University of Texas Medical Branch, Galveston
Organization:
Study Overview
Official Title:
Protein Biomarker Discovery and Validation in COPD And Asthma
Status:
TERMINATED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
NIH Funded Grant Expired
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Proteomics
Brief Summary:
The purpose of the study is to better understand proteomics of asthma and COPD, and response to therapy. There are two Phases to this study broken into two arms. In Phase I, we propose is to use discovery proteomics and techniques to identify protein expression signatures. Subjects who complete Phase I are eligible, but not required, to enroll in Phase II. In Phase II, we propose to establish and validate the predictive value of protein signatures for treatment responses using inhaled corticosteroids.
Detailed Description:
There are two Phases to this study broken into two arms. In Phase I, our propose to use discovery proteomics and high throughput techniques to identify protein expression signatures. The total planned size of Phase I is 100 patients. Patients will be divided into two arms based on disease status (COPD or asthma). Active smoking will be defined as daily use of cigarettes, pipes, cigarillos or cigars at time of entry into the study and through duration of study. No active smoking defined as never smoking or having stopped smoking for 5 years or greater.
In the Phase II, we aim to establish and validate the predictive value of proteomic signatures for therapeutic responses using inhaled corticosteroids. For Phase II, subjects who completed Phase I are eligible, but not required to participate in Phase II.
In the Phase II, we aim to establish and validate the predictive value of proteomic signatures for therapeutic responses using inhaled corticosteroids. For Phase II, subjects who completed Phase I are eligible, but not required to participate in Phase II.
Study Oversight
Has Oversight DMC:
True
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?: