Pulmonary Arterial HypertensionNCT01494896
Impact of Inhaled Treprostinil Sodium on Ventilation Perfusion Matching
An observational study of Pulmonary Arterial Hypertension and Chronic Obstructive Pulmonary Disease, run by University of Florida at 3 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Arterial Hypertension, Chronic Obstructive Pulmonary Disease
- How many people
- 9 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2011to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects initiated on inhaled treprostinil sodium for treatment of PAH who have concomitant COPD.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Florida, Jacksonville
Jacksonville, Florida, 32209
Mayo Clinic
Jacksonville, Florida, 32224
Cleveland Clinic Florida
Weston, Florida, 33331
About this study
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)
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).
Read the 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.
- Keywords
- 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
- Medical subject headings
- Pulmonary Arterial Hypertension, Pulmonary Disease, Chronic Obstructive, Hypertension, Pulmonary
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oxygen saturation in subject initiated on inhaled treprostinil sodium for treatment of PAH who have concomintant COPD.
Measured: Dec 2014
Secondary outcomes (1)
Change in 6MWT in subject initiated on inhaled treprostinil sodium for treatment of PAH who have concomintant COPD.
Measured: December 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: due to slow enrollment. United Therapeutics and Dr. Bajwa MD decided to terminate study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- United Therapeutics
- Responsible party
- Sponsor
- Investigators
- Abubakr A Bajwa, MD, FCCP, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01494896
- Sponsor's protocol ID
- Tyvaso COPD
- Status last verified
- Aug 2013
- First submitted
- 15 Dec 2011
- Last updated
- 7 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01494896
- Acronym / sponsor ID
- Tyvaso COPD
- Keywords
- Pulmonary Hypertension, Pulmonary Arterial Hypertension, COPD, Chronic Obstructive Pulmonary Disease, Tyvaso, Inhaled Treprostinil Sodium, Ventilation Perfusion Matching, HO Group 1 Pulmonary Arterial Hypertension
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: due to slow enrollment. United Therapeutics and Dr. Bajwa MD decided to terminate study
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- United Therapeutics
- Study start
- Nov 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 19 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects initiated on inhaled treprostinil sodium for treatment of PAH who have concomitant COPD.
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Oxygen saturation in subject initiated on inhaled treprostinil sodium for treatment of PAH who have concomintant COPD.
Time frame: Dec 2014
1 secondary outcome
Change in 6MWT in subject initiated on inhaled treprostinil sodium for treatment of PAH who have concomintant COPD.
Time frame: December 2014
Results and safety
The study was stopped early (reason given: due to slow enrollment. United Therapeutics and Dr. Bajwa MD decided to terminate study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abubakr A Bajwa, MD, FCCP principal investigator
University of Florida
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Arterial Hypertension and Chronic Obstructive Pulmonary Disease, run by University of Florida at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: due to slow enrollment. United Therapeutics and Dr. Bajwa MD decided to terminate study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Oxygen saturation in subject initiated on inhaled treprostinil sodium for treatment of PAH who have concomintant COPD. (time frame: Dec 2014). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2015.