Treatment of Pulmonary Hypertension Associated COPD With Inhaled Treprostinil-1

NCT01758744 | Completed Phase 1 DMC

• 1 other identifier: 12-0560
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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)

Conditions

Pulmonary Hypertension; COPD

Keywords

COPD PH; COPD associated Pulmonary Hypertension; COPD and Pulmonary Hypertension; Disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• New York Heart Association (NYHA) functional class

  Change in New York Heart Association (NYHA) functional class assessed at baseline and at week 4.

• Six minute walk distance

  Change from baseline in 6 minute walk distance at 4 weeks

• Clinical Worsening

  From the time of randomization to until the subject discontinues from study for any cause, assessed up to 4 weeks

• 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

• St. George's Chronic Obstructive Pulmonary Disease (COPD) questionnaire

  change from baseline in the St. George's respiratory questionnaire at 4 weeks

Study Arms (1)

Treprostinil

EXPERIMENTAL

Inhaled prostanoid therapy with Treprostinil

Drug: Inhaled Treprostinil Therapy

Interventions

Inhaled Treprostinil Therapy DRUG

Treprostinil: Inhaled prostanoid therapy

Also known as: Tyvaso ®

Treprostinil

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (2)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

University of Florida College of Medicine

Jacksonville, Florida, 32209, United States

Location

MeSH Terms

Conditions

Hypertension, Pulmonary; Pulmonary Disease, Chronic Obstructive; Disease

Interventions

treprostinil

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Todd M. Bull, M.D.

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2012
• First Posted: January 1, 2013
• Study Start: December 1, 2012
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 20, 2016

Record last verified: 2016-07

Locations

US (2)