Impact of Inhaled Treprostinil Sodium on Ventilation Perfusion Matching
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)
Visão geral do estudo
Status
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
-
Florida
-
Jacksonville, Florida, Estados Unidos, 32224
- Mayo Clinic
-
Jacksonville, Florida, Estados Unidos, 32209
- University of Florida, Jacksonville
-
Weston, Florida, Estados Unidos, 33331
- Cleveland Clinic Florida
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Change in Oxygen saturation in subject initiated on inhaled treprostinil sodium for treatment of PAH who have concomintant COPD.
Prazo: Dec 2014
|
Dec 2014
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Change in 6MWT in subject initiated on inhaled treprostinil sodium for treatment of PAH who have concomintant COPD.
Prazo: December 2014
|
December 2014
|
Outras medidas de resultado
Medida de resultado |
Prazo |
|---|---|
|
SGRQ questionaires
Prazo: December 2014
|
December 2014
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Abubakr A Bajwa, MD, FCCP, University of Florida
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Tyvaso COPD
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .