Treatment of Pulmonary Hypertension Associated COPD With Inhaled Treprostinil-1 (TAPIT-1)
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ClinicalTrials.gov Identifier: NCT01758744 |
Recruitment Status
:
Completed
First Posted
: January 1, 2013
Last Update Posted
: July 20, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pulmonary Hypertension COPD | Drug: Inhaled Treprostinil Therapy | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10 participants |
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 |
Study Start Date : | December 2012 |
Actual Primary Completion Date : | July 2016 |
Actual Study Completion Date : | July 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: Treprostinil
Inhaled prostanoid therapy with Treprostinil
|
Drug: Inhaled Treprostinil Therapy
Treprostinil: Inhaled prostanoid therapy
Other Name: Tyvaso ®
|
- 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)
- 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.

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

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
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 |
Principal Investigator: | Todd M. Bull, M.D. | University of Colorado, Denver |
Responsible Party: | University of Colorado, Denver |
ClinicalTrials.gov Identifier: | NCT01758744 History of Changes |
Other Study ID Numbers: |
12-0560 |
First Posted: | January 1, 2013 Key Record Dates |
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 |