Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00483743
Status:
COMPLETED
Last Update Posted:
2012-12-03
First Post:
2007-05-23
Brief Title:
Safety Tolerability and PD Activity of Inhaled TPI 1020 Versus Inhaled Budesonide in COPD Patients
Sponsor:
Syntara
Organization:
Syntara
Study Overview
Official Title:
Multi-Center Randomized Double-Blind Placebo and Active-Controlled 6-week Study to Evaluate the Safety Tolerability and Pharmacodynamic Activity of Inhaled TPI 1020 in COPD Patients
Status:
COMPLETED
Status Verified Date:
2012-11
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:
This study will assess and compare the safety and tolerability of inhaled TPI 1020 repeated nominal doses 500 μg BID x 6 weeks versus inhaled budesonide repeated doses 800 μg BID x 6 weeks and a matching placebo Pharmacodynamic PD activity on FEV1 sputum and blood cells and cytokines will also be studied
Detailed Description:
A multi-centre randomized placebo and active-controlled 6-week study of inhaled TPI 1020 inhaled budesonide or matching placebo random allocation of eligible patients to the three treatments at a ratio of 331 to evaluate the safety tolerability and pharmacodynamic activity of TPI 1020 in 42 evaluable COPD subjects
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