Treatment of Pulmonary Hypertension Associated COPD With Inhaled Treprostinil-1 (TAPIT-1)

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

• Status: Completed
• Conditions: Pulmonary Hypertension; COPD
• Intervention / Treatment: Drug: Inhaled Treprostinil Therapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver
  • Florida
    • Jacksonville, Florida, United States, 32209
      • University of Florida College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treprostinil; Inhaled prostanoid therapy with Treprostinil	Drug: Inhaled Treprostinil Therapy; Treprostinil: Inhaled prostanoid therapy; Other Names: Tyvaso ®

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Todd M. Bull, M.D., University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: December 6, 2012
• First Submitted That Met QC Criteria: December 26, 2012
• First Posted (Estimate): January 1, 2013

Study Record Updates

• Last Update Posted (Estimate): July 20, 2016
• Last Update Submitted That Met QC Criteria: July 18, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Disease; COPD PH; COPD associated Pulmonary Hypertension; COPD and Pulmonary Hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary; Antihypertensive Agents; Treprostinil
• Other Study ID Numbers: 12-0560