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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01758744

First Posted: January 1, 2013

Last Update Posted: July 20, 2016

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

University of Colorado, Denver

Purpose

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)

Condition	Intervention	Phase
Pulmonary Hypertension COPD	Drug: Inhaled Treprostinil Therapy	Phase 1


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	TAPIT-1: Treatment of Pulmonary Hypertension Associated COPD With Inhaled Treprostinil-1

Resource links provided by NLM:

MedlinePlus related topics: Pulmonary Hypertension

Drug Information available for: Treprostinil Treprostinil diolamine

U.S. FDA Resources

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:

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 ]
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 [ Time Frame: Change in New York Heart Association (NYHA) functional class assessed at baseline and at week 4. ]
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 ]
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 ]
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 ]
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 ]
The St. George's questionnaire is a quality of life questionnaire completed by the subject at baseline and at week 4.


Enrollment:	10
Study Start Date:	December 2012
Study Completion Date:	July 2016
Primary Completion Date:	July 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Treprostinil Inhaled prostanoid therapy with Treprostinil	Drug: Inhaled Treprostinil Therapy Treprostinil: Inhaled prostanoid therapy Other Name: Tyvaso ®

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.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	30 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01758744

Locations


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

Sponsors and Collaborators

University of Colorado, Denver

Investigators


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

More Information


Responsible Party:	University of Colorado, Denver
ClinicalTrials.gov Identifier:	NCT01758744 History of Changes
Other Study ID Numbers:	12-0560
First Submitted:	December 6, 2012
First Posted:	January 1, 2013
Last Update Posted:	July 20, 2016
Last Verified:	July 2016

Keywords provided by University of Colorado, Denver:


COPD PH COPD associated Pulmonary Hypertension COPD and Pulmonary Hypertension Disease

Additional relevant MeSH terms:


Hypertension Hypertension, Pulmonary Vascular Diseases Cardiovascular Diseases	Lung Diseases Respiratory Tract Diseases Treprostinil Antihypertensive Agents

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