Treatment of Pulmonary Hypertension Associated COPD With Inhaled Treprostinil-1

COPD Clinical Trial

— TAPIT-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01758744
• Other study ID #: 12-0560
• Status: Completed
• Phase: Phase 1
• First received: December 6, 2012
• Last updated: July 18, 2016
• Start date: December 2012
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD
• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Drug:
• Inhaled Treprostinil Therapy
Treprostinil: Inhaled prostanoid therapy

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado
United States	University of Florida College of Medicine	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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.	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	No
Secondary	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	No