Treatment of Pulmonary Hypertension Associated COPD With Inhaled Treprostinil-1 (TAPIT-1)
An Open Label, Pilot Study Testing the Safety and Efficacy of Inhaled Treprostinil (Tyvaso®) in the Treatment of Pulmonary Hypertension (PH) Associated with Chronic Obstructive Pulmonary Disease (COPD)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||TAPIT-1: Treatment of Pulmonary Hypertension Associated COPD With Inhaled Treprostinil-1|
- To assess the safety of Tyvaso ® as assessed by changes or stability of acute oxygenation (pulse oximetry) and spirometry (FEV1). [ Time Frame: This is a 4 week trial ] [ Designated as safety issue: Yes ]A 4-Week, Open Label Study Testing the Safety of Inhaled Treprostinil (Tyvaso®) in the Treatment of Pulmonary Hypertension (PH) Associated with Chronic Obstructive Lung Disease (COPD) (PH-COPD)
- New York Heart Association (NYHA) functional class [ Time Frame: Change in New York Heart Association (NYHA) functional class assessed at baseline and at week 4. ] [ Designated as safety issue: Yes ]A change in functional class is assessed as improvement or deterioration in the patient's functional status
- Six minute walk distance [ Time Frame: Change from baseline in 6 minute walk distance at 4 weeks ] [ Designated as safety issue: Yes ]A change in how far the subject can walk in 6 minutes will be measured at baseline and compared to how far the subject can walk in 6 minutes at week 4.
- Clinical Worsening [ Time Frame: From the time of randomization to until the subject discontinues from study for any cause, assessed up to 4 weeks ] [ Designated as safety issue: Yes ]Clinical worsening is described as Death, hospitalization (all cause)and COPD exacerbations (worsening of respiratory symptoms which require treatment with oral corticosteroids, antibiotics or both).
- Peripheral Blood Mononuclear Cells (PBMC) phagocytic index (PI) and PBMC gene expression [ Time Frame: Change from baseline in PBMC PI and PBMC gene expression at 4 weeks ] [ Designated as safety issue: No ]
The phagocytic index is the average number of bacteria ingested per phagocyte in an incubated mixture of bacteria, phagocytes, and blood serum. We will also be looking a a change in gene expression of these (PBMC) cells.
- St. George's Chronic Obstructive Pulmonary Disease (COPD) questionnaire [ Time Frame: change from baseline in the St. George's respiratory questionnaire at 4 weeks ] [ Designated as safety issue: No ]The St. George's questionnaire is a quality of life questionnaire completed by the subject at baseline and at week 4.
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Inhaled prostanoid therapy with Treprostinil
Drug: Inhaled Treprostinil Therapy
Treprostinil: Inhaled prostanoid therapy
Other Name: Tyvaso ®
This is a pilot study of 10 patients that have COPD-PH. Primary outcome measure is to see if this drug is safe for this patient population and the secondary measure is to see if the drug improves patient functional capacity.
|Contact: Cheri Abbott, RNfirstname.lastname@example.org|
|United States, Colorado|
|University of Colorado Denver||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Cheri Abbott, RN 303-724-7466 email@example.com|
|Principal Investigator: Todd M. Bull, M.D.|
|Principal Investigator:||Todd M. Bull, M.D.||University of Colorado, Denver|