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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01758744
|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|