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

Primary Purpose

Pulmonary Hypertension, COPD

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Inhaled Treprostinil Therapy
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Hypertension focused on measuring COPD PH, COPD associated Pulmonary Hypertension, COPD and Pulmonary Hypertension, Disease

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Colorado Denver
  • University of Florida College of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treprostinil

Arm Description

Inhaled prostanoid therapy with Treprostinil

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

New York Heart Association (NYHA) functional class
A change in functional class is assessed as improvement or deterioration in the patient's functional status
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.
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).
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. ------------------------------------------------------------------------------
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.

Full Information

First Posted
December 6, 2012
Last Updated
July 18, 2016
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT01758744
Brief Title
Treatment of Pulmonary Hypertension Associated COPD With Inhaled Treprostinil-1
Acronym
TAPIT-1
Official Title
TAPIT-1: Treatment of Pulmonary Hypertension Associated COPD With Inhaled Treprostinil-1
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension, COPD
Keywords
COPD PH, COPD associated Pulmonary Hypertension, COPD and Pulmonary Hypertension, Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treprostinil
Arm Type
Experimental
Arm Description
Inhaled prostanoid therapy with Treprostinil
Intervention Type
Drug
Intervention Name(s)
Inhaled Treprostinil Therapy
Other Intervention Name(s)
Tyvaso ®
Intervention Description
Treprostinil: Inhaled prostanoid therapy
Primary Outcome Measure Information:
Title
To assess the safety of Tyvaso ® as assessed by changes or stability of acute oxygenation (pulse oximetry) and spirometry (FEV1).
Description
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)
Time Frame
This is a 4 week trial
Secondary Outcome Measure Information:
Title
New York Heart Association (NYHA) functional class
Description
A change in functional class is assessed as improvement or deterioration in the patient's functional status
Time Frame
Change in New York Heart Association (NYHA) functional class assessed at baseline and at week 4.
Title
Six minute walk distance
Description
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.
Time Frame
Change from baseline in 6 minute walk distance at 4 weeks
Title
Clinical Worsening
Description
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).
Time Frame
From the time of randomization to until the subject discontinues from study for any cause, assessed up to 4 weeks
Title
Peripheral Blood Mononuclear Cells (PBMC) phagocytic index (PI) and PBMC gene expression
Description
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. ------------------------------------------------------------------------------
Time Frame
Change from baseline in PBMC PI and PBMC gene expression at 4 weeks
Title
St. George's Chronic Obstructive Pulmonary Disease (COPD) questionnaire
Description
The St. George's questionnaire is a quality of life questionnaire completed by the subject at baseline and at week 4.
Time Frame
change from baseline in the St. George's respiratory questionnaire at 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd M. Bull, M.D.
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Florida College of Medicine
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States

12. IPD Sharing Statement

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Treatment of Pulmonary Hypertension Associated COPD With Inhaled Treprostinil-1

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