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

This study is currently recruiting participants.
Verified November 2013 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: November 25, 2013
Last verified: November 2013

December 6, 2012
November 25, 2013
December 2012
December 2013   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01758744 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Treatment of Pulmonary Hypertension Associated COPD With Inhaled Treprostinil-1
TAPIT-1: 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)

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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pulmonary Hypertension
  • COPD
Drug: Inhaled Treprostinil Therapy
Treprostinil: Inhaled prostanoid therapy
Other Name: Tyvaso ®
Experimental: Treprostinil
Inhaled prostanoid therapy with Treprostinil
Intervention: Drug: Inhaled Treprostinil Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
June 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
30 Years to 80 Years
No
Contact: Cheri Abbott, RN 303-724-7466 cheryl.abbott@ucdenver.edu
United States
 
NCT01758744
12-0560
Yes
University of Colorado, Denver
University of Colorado, Denver
Not Provided
Principal Investigator: Todd M. Bull, M.D. University of Colorado, Denver
University of Colorado, Denver
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP