Treatment of Pulmonary Hypertension Associated COPD With Inhaled Treprostinil-1

Phase 1

Completed

• Conditions: Pulmonary Hypertension; COPD
• Interventions: Drug: Inhaled Treprostinil Therapy

• Registration Number: NCT01758744
• Lead Sponsor: University of Colorado, Denver

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.

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-06
• Study First Submitted QC: 2012-12-26
• Study First Posted: 2013-01-01
• Status Verified: 2016-07
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Last Update Submitted: 2016-07-18
• Last Update Posted: 2016-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treprostinil	Inhaled Treprostinil Therapy	Inhaled prostanoid therapy with Treprostinil

Primary Outcome Measures

Name	Time	Method
To assess the safety of Tyvaso ® as assessed by changes or stability of acute oxygenation (pulse oximetry) and spirometry (FEV1).	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

Name	Time	Method
Peripheral Blood Mononuclear Cells (PBMC) phagocytic index (PI) and PBMC gene expression	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.; ------------------------------------------------------------------------------
New York Heart Association (NYHA) functional class	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	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	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).
St. George's Chronic Obstructive Pulmonary Disease (COPD) questionnaire	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.

Trial Locations

Locations (2)

University of Florida College of Medicine; 🇺🇸 Jacksonville, Florida, United States

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States