Impact of Inhaled Treprostinil Sodium on Ventilation Perfusion Matching

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University of Florida
Sponsor:
Collaborator:
United Therapeutics
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01494896
First received: December 15, 2011
Last updated: September 26, 2013
Last verified: August 2013
  Purpose

The purpose of this study is to see how inhaled treprostinil sodium (Tyvaso) affects the amount of air and blood that reach the alveoli, or tiy air sacs, in the lungs of patients with Group 1 Pulmonary Arterial Hypertension with concomitant Chronic Obstructive Pulmonary Disease (COPD).


Condition
Pulmonary Arterial Hypertension
Chronic Obstructive Pulmonary Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: An Open-Label Study to Explore the Impact of Inhaled Treprostinil Sodium on Ventilation Perfusion Matching When Used for Treatment of Group 1 Pulmonary Arterial Hypertension in Patients With Concomitant Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Change in Oxygen saturation in subject initiated on inhaled treprostinil sodium for treatment of PAH who have concomintant COPD. [ Time Frame: Dec 2014 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in 6MWT in subject initiated on inhaled treprostinil sodium for treatment of PAH who have concomintant COPD. [ Time Frame: December 2014 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • SGRQ questionaires [ Time Frame: December 2014 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: November 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Detailed Description:

In patients with severe COPD where the FEV1 is 50% or less than predicted, emphysema and obliterating bronchiolitis presenting a "ceiling" to any improvement in function that can be achieved by therapies that dilate the airways or lessen inflammation. Such severe COPD is commonly associated with pulmonary hypertension at rest or during exercise. Although hypoxia has been classically considered to be the major pathogenic mechanism of pulmonary hypertension in COPD and oxygen has been the mainstay of therapy, other mechanisms may play important roles. Indeed, endothelial dysfunction can be observed in patients with mild to moderate COPD who do not have hypoxemia and in smokers with normal lung function. In addition, long-term oxygen therapy does not generally result in resolution of the pulmonary hypertension. A key question that remains is whether the newer therapies for pulmonary arterial hypertension (PAH) could improve pulmonary hypertension and therefore exercise tolerance in COPD.

Unfortunately the use of non-selective pulmonary vasodilator therapy in oral, intravenous or subcutaneous form for PAH patients who have unrelated concomitant COPD, is known to cause worsening gas exchange and intensification of symptoms despite a decrease in pulmonary vascular resistance and arterial pressures.

We hypothesize that an inhaled pulmonary vasodilator may not worsen ventilation-perfusion mismatching by selectively vasodilating well ventilated areas in PAH patients with concomitant COPD and in fact may improve ventilation perfusion matching leading to preservation or improvement of oxygenation.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects initiated on inhaled treprostinil sodium for treatment of PAH who have concomitant COPD.

Criteria

Inclusion Criteria:

  • Subject has a diagnosis of PAH confirmed by right heart catheterization within the last 12 months (defined by mean pulmonary artery pressure of greater than or equal to 25 with pulmonary capillary wedge pressure or left ventricular end-diastolic pressure of less than or equal to 15).
  • Subject is being initiated on inhaled treprostinil for treatment of PAH.
  • Subject between 18 and 80 years of age at screening with a diagnosis of COPD confirmed by spirometry within the last 6 months showing FEV1 > 40% predicted and FEV/FVC of < 70.
  • Baseline 6-minute walk distance > 150 meters.
  • Subject has not been on any approved therapy for their PH for the last 90 days.
  • If subject is being treated with conventional therapy for COPD, they must be receiving a fixed regimen of these therapies for tat least 30 days prior to Baseline.
  • Previous echocardiography with evidence of normal left systolic and diastolic ventricular function, and absence of any clinically significant left sided heart disease.
  • If female, physiologically incapable of childbearing or practicing an acceptable method of birth control as deemed appropriate by the physician or institution.
  • If female, negative serum pregnancy test required at screening.
  • Subject voluntarily gives informed consent.

Exclusion Criteria:

  • The subject is pregnant or lactating.
  • Subject has had a new type of chronic therapy for PH added within 90 days of Baseline.
  • Subject has had any medication started or discontinued for COPD within 30 days of Baseline.
  • Subject has any of the following: portal hypertension, chronic thromboembolic disease, pulmonary veno-occlusive disease or other than those accepted as part of the inclusion criteria or has had any atrial septostomy.
  • Subject has a current diagnosis of uncontrolled sleep apnea as defined by their physician.
  • Subject has a history or current evidence of left-sided heart disease.
  • Subject has interstitial lung disease as evidence by CT scan or restrictive pattern on pulmonary function tests (FEV1/FVC > 70 and TLC < 80% predicted) or COPD with FEV1 < 40% predicted.
  • Subject has a musculoskeletal disorder or any other disease that is likely to limit ambulation, or is connected to a machine that is not portable.
  • Subject is incapable of maintaining compliance throughout the course of the study.
  • Any condition, in the investigator's opinion, would constitute an unacceptable risk to the subject's safety.
  • Subject is receiving an investigational drug, has an investigational device in place or has participated in an investigational drug or device study within 30 days prior to screening.
  • Subjects without a telephone contact.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01494896

Contacts
Contact: Minal Patel 904.244.1106 minal.patel@jax.ufl.edu

Locations
United States, Florida
University of Florida, Jacksonville Recruiting
Jacksonville, Florida, United States, 32209
Principal Investigator: Abubakr A Bajwa, MD, FCCP         
Sub-Investigator: Adil Shujaat, MD         
Mayo Clinic Not yet recruiting
Jacksonville, Florida, United States, 32224
Contact: Pamela Long, RN    904-953-7718    long.pamela@mayo.edu   
Contact: Ellen Miceli, RN    904-953-8939    miceli.ellen@mayo.edu   
Principal Investigator: Charles D Burger, MD         
Cleveland Clinic Florida Not yet recruiting
Weston, Florida, United States, 33331
Contact: Norma J Barton    954-659-5450    bartonn2@ccf.org   
Principal Investigator: Franck F Rahaghi, MD         
Sub-Investigator: Gustavo Ferrer, MD         
Sub-Investigator: Ndubuisi Okafor, MD         
Sponsors and Collaborators
University of Florida
United Therapeutics
Investigators
Principal Investigator: Abubakr A Bajwa, MD, FCCP University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01494896     History of Changes
Other Study ID Numbers: Tyvaso COPD
Study First Received: December 15, 2011
Last Updated: September 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Pulmonary Hypertension
Pulmonary Arterial Hypertension
COPD
Chronic Obstructive Pulmonary Disease
Tyvaso
Inhaled Treprostinil Sodium
Ventilation Perfusion Matching
HO Group 1 Pulmonary Arterial Hypertension
Concomitant Chronic Obstructive Pulmonary Disease

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Treprostinil
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014