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

This study is currently recruiting participants. (see Contacts and Locations)

Verified December 2014 by University of Colorado, Denver

Sponsor:

Information provided by (Responsible Party):

University of Colorado, Denver

ClinicalTrials.gov Identifier:

NCT01758744

First received: December 6, 2012

Last updated: December 1, 2014

Last verified: December 2014

History of Changes

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:	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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure Pulmonary Hypertension

Drug Information available for: Treprostinil Treprostinil sodium

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 ] [ 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)

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. ] [ 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.


Estimated Enrollment:	10
Study Start Date:	December 2012
Estimated Study Completion Date:	December 2015
Estimated Primary Completion Date:	November 2015 (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


Ages Eligible for Study:	30 Years to 80 Years
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts


Contact: Cheri Abbott, RN	303-724-7466	cheryl.abbott@ucdenver.edu

Locations


United States, Colorado
University of Colorado Denver	Recruiting
Aurora, Colorado, United States, 80045
Contact: Cheri Abbott, RN 303-724-7466 cheryl.abbott@ucdenver.edu
Principal Investigator: Todd M. Bull, M.D.

Sponsors and Collaborators

University of Colorado, Denver

Investigators


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

More Information

No publications provided


Responsible Party:	University of Colorado, Denver
ClinicalTrials.gov Identifier:	NCT01758744 History of Changes
Other Study ID Numbers:	12-0560
Study First Received:	December 6, 2012
Last Updated:	December 1, 2014
Health Authority:	United States: Food and Drug Administration

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 Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases Vascular Diseases	Treprostinil Antihypertensive Agents Cardiovascular Agents Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on February 25, 2015

To Top