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

This study is not yet open for participant recruitment.
Verified December 2012 by University of Colorado, Denver
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01758744
First received: December 6, 2012
Last updated: December 26, 2012
Last verified: December 2012
History of Changes
  Purpose

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)


Condition Intervention Phase
Pulmonary Hypertension
COPD
 Drug: Inhaled Treprostinil Therapy
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: TAPIT-1: Treatment of Pulmonary Hypertension Associated COPD With Inhaled Treprostinil-1

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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:
  • 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. ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]

    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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  • St. George's Chronic Obstructive Pulmonary Disease (COPD) questionnaire [ Time Frame: change from baseline in the St. George's respiratory questionnaire at 4 weeks ] [ Designated as safety issue: No ]
    The St. George's questionnaire is a quality of life questionnaire completed by the subject at baseline and at week 4.


Estimated Enrollment: 10
Study Start Date: December 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treprostinil
Inhaled prostanoid therapy with Treprostinil
 Drug: Inhaled Treprostinil Therapy
Treprostinil: Inhaled prostanoid therapy
Other Name: Tyvaso ®

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.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01758744

Contacts
Contact: Cheri Abbott, RN 303-724-7466 cheryl.abbott@ucdenver.edu

Locations
United States, Colorado
University of Colorado Denver Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Cheri Abbott, RN     303-724-7466     cheryl.abbott@ucdenver.edu    
Principal Investigator: Todd M. Bull, M.D.            
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Todd M. Bull, M.D. University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01758744     History of Changes
Other Study ID Numbers: 12-0560
Study First Received: December 6, 2012
Last Updated: December 26, 2012
Health Authority: United States: Food and Drug Administration

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
Pulmonary Disease, Chronic Obstructive
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
 Lung Diseases, Obstructive
Treprostinil
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013