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Impact of Inhaled Treprostinil Sodium on Ventilation Perfusion Matching

6 mei 2015 bijgewerkt door: University of Florida

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)

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).

Studie Overzicht

Toestand

Beëindigd

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

9

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Florida
      • Jacksonville, Florida, Verenigde Staten, 32224
        • Mayo Clinic
      • Jacksonville, Florida, Verenigde Staten, 32209
        • University of Florida, Jacksonville
      • Weston, Florida, Verenigde Staten, 33331
        • Cleveland Clinic Florida

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 80 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Change in Oxygen saturation in subject initiated on inhaled treprostinil sodium for treatment of PAH who have concomintant COPD.
Tijdsspanne: Dec 2014
Dec 2014

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Change in 6MWT in subject initiated on inhaled treprostinil sodium for treatment of PAH who have concomintant COPD.
Tijdsspanne: December 2014
December 2014

Andere uitkomstmaten

Uitkomstmaat
Tijdsspanne
SGRQ questionaires
Tijdsspanne: December 2014
December 2014

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Florida

Medewerkers

United Therapeutics

Onderzoekers

  • Hoofdonderzoeker: Abubakr A Bajwa, MD, FCCP, University of Florida

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 november 2011

Primaire voltooiing (Werkelijk)

1 december 2014

Studie voltooiing (Werkelijk)

1 december 2014

Studieregistratiedata

Eerst ingediend

15 december 2011

Eerst ingediend dat voldeed aan de QC-criteria

16 december 2011

Eerst geplaatst (Schatting)

19 december 2011

Updates van studierecords

Laatste update geplaatst (Schatting)

7 mei 2015

Laatste update ingediend die voldeed aan QC-criteria

6 mei 2015

Laatst geverifieerd

1 augustus 2013

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • Tyvaso COPD

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