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Completed

NCT Number: NCT01758744

Treatment of Pulmonary Hypertension Associated COPD With Inhaled Treprostinil-1

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)

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Key information

Conditions

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

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Colorado Denver, Aurora, Colorado, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inhaled Treprostinil Therapy

Drug

Treprostinil: Inhaled prostanoid therapy

Other names: Tyvaso ®

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. 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.

  3. 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).

  4. 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.

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  5. 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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

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

Acronym: TAPIT-1

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jan 1, 2013
Registry last updated
Jul 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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