Treatment of Pulmonary Hypertension Associated COPD With Inhaled Treprostinil-1

Study Overview
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Brief Summary
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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)

Detailed Description
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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.

Official Title
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TAPIT-1: Treatment of Pulmonary Hypertension Associated COPD With Inhaled Treprostinil-1

Conditions
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Pulmonary Hypertension, COPD

Intervention / Treatment
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* Drug: Inhaled Treprostinil Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: must have: be between the ages of 30 and 80 have a clinical diagnosis of Gold stage 2 to 4 COPD have a diagnosis of pulmonary hypertension established by a historic right heart catheterization a minimum weight of 45 Kg minimum systolic blood pressure of >90 mmHg be able to perform a six minute walk test be able to maintain a oxygen saturation >88% at rest (with or without oxygen) be treated with background therapy for COPD for a minimum of 1 month prior to consideration of enrollment. be competent to understand the information given in the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approved Informed Consent Form and must sign the form prior to the initiation of any study procedure. Exclusion Criteria. Cannot have or be: The presence of pulmonary venous hypertension defined by a historical right heart catheterization Gold Stage I COPD documented left ventricular dysfunction as measured by echocardiography pregnant or breastfeeding Recipient of a lung transplant received chronic prostanoid therapy for pulmonary hypertension within 4 weeks prior to the screening appointment A requirement of greater than 9 l/min of O2 to maintain oxygen saturations greater than 88% at rest No other serious medical conditions

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treprostinil<br>Inhaled prostanoid therapy with Treprostinil | Drug: Inhaled Treprostinil Therapy<br>* Treprostinil: Inhaled prostanoid therapy<br>* Other names: Tyvaso ®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety of Tyvaso ® as assessed by changes or stability of acute oxygenation (pulse oximetry) and spirometry (FEV1). | 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) | This is a 4 week trial | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New York Heart Association (NYHA) functional class | A change in functional class is assessed as improvement or deterioration in the patient's functional status | Change in New York Heart Association (NYHA) functional class assessed at baseline and at week 4. | 
| Six minute walk distance | 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. | Change from baseline in 6 minute walk distance at 4 weeks | 
| Clinical Worsening | 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). | From the time of randomization to until the subject discontinues from study for any cause, assessed up to 4 weeks | 
| Peripheral Blood Mononuclear Cells (PBMC) phagocytic index (PI) and PBMC gene expression | 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. ------------------------------------------------------------------------------ | Change from baseline in PBMC PI and PBMC gene expression at 4 weeks | 
| St. George's Chronic Obstructive Pulmonary Disease (COPD) questionnaire | The St. George's questionnaire is a quality of life questionnaire completed by the subject at baseline and at week 4. | change from baseline in the St. George's respiratory questionnaire at 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD PH, COPD associated Pulmonary Hypertension, COPD and Pulmonary Hypertension, Disease