Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00322868
Status:
COMPLETED
Last Update Posted:
2018-02-23
First Post:
2006-05-04
Brief Title:
Safety and Efficacy of Pioglitazone as an Anti-inflammatory for the Treatment of Cystic Fibrosis CF Lung Disease
Sponsor:
University Hospitals Cleveland Medical Center
Organization:
University Hospitals Cleveland Medical Center
Study Overview
Official Title:
A Pilot Study Assessing the Safety and Efficacy of Pioglitazone as an Anti-inflammatory Agent for the Treatment of CF Lung Disease in Patients With Cystic Fibrosis
Status:
COMPLETED
Status Verified Date:
2018-02
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:
Study Hypothesis Pioglitazone may decrease inflammation in cystic fibrosis lung disease
Primary outcomes Markers of inflammation neutrophils elastase cytokines and bacteriawill be measured in induced sputum specimens before and after a 4 week treatment period with pioglitazone in clinically stable CF patients
Primary outcomes Markers of inflammation neutrophils elastase cytokines and bacteriawill be measured in induced sputum specimens before and after a 4 week treatment period with pioglitazone in clinically stable CF patients
Detailed Description:
Single-center open label study of pioglitazone in clinically stable patients with mild to moderate CF lung disease
Induced sputum will be obtained from each subject at enrollment Baseline and again following 28 days of pioglitazone treatment End of Treatment
Changes in markers of inflammation in the sputum samples will be assessed
Safety measures including complete blood count CBC serum chemistry Erythrocyte sedimentation rate ESR C-Reactive Protein CRP urinalysis and spirometry will also be assessed
Induced sputum will be obtained from each subject at enrollment Baseline and again following 28 days of pioglitazone treatment End of Treatment
Changes in markers of inflammation in the sputum samples will be assessed
Safety measures including complete blood count CBC serum chemistry Erythrocyte sedimentation rate ESR C-Reactive Protein CRP urinalysis and spirometry will also be assessed
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