Pulmonary Rehab in Chronic Obstructive Pulmonary Disease (COPD): Response to Tyvaso
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02178566 |
Recruitment Status :
Terminated
(Unable to enroll)
First Posted : July 1, 2014
Results First Posted : April 12, 2022
Last Update Posted : April 12, 2022
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Obstructive Pulmonary Disease (COPD) | Drug: Inhaled Treprostinil | Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Pulmonary Rehabilitation in COPD: Response to Inhaled Treprostinil (Tyvaso) |
Actual Study Start Date : | August 2015 |
Actual Primary Completion Date : | January 2019 |
Actual Study Completion Date : | January 2019 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Inhaled Treprostinil Placebo
A dose of placebo resembling inhaled treprostinil will be administered to all study participants in the placebo comparator arm prior to each of their Pulmonary Rehab sessions. A dose of inhaled albuterol will be administered prior to each inhaled agent. Vitals signs will be taken prior to administering the dose and no medication will be given if the systolic blood pressure in < 85 mm Hg. Three puffs of inhaled trepostinil dose will be administered each time to all patients .
|
Drug: Inhaled Treprostinil
A dose of inhaled treprostinil or placebo will be administered to all study participants prior to each of their Pulmonary Rehab sessions. Three puffs of inhaled treprostinil dose will be administered each time to all patients .
Other Name: Tyvaso |
Active Comparator: Inhaled Treprostinil
A dose of inhaled treprostinil will be administered to all study participants prior to each of their Pulmonary Rehab sessions. A dose of inhaled albuterol will be administered prior to each inhaled agent. Vitals signs will be taken prior to administering the dose and no medication will be given if the systolic blood pressure in < 85 mm Hg. Three puffs of inhaled treprostinil dose will be administered each time to all patients .
|
Drug: Inhaled Treprostinil
A dose of inhaled treprostinil or placebo will be administered to all study participants prior to each of their Pulmonary Rehab sessions. Three puffs of inhaled treprostinil dose will be administered each time to all patients .
Other Name: Tyvaso |
- Distance Walked on 6MWT [ Time Frame: 9 weeks ]To determine the effect of inhaled treprostinil, administered prior to pulmonary rehabilitation sessions, on the six minute walk test distance (6MWT) in COPD patients after completing an 8 week course of pulmonary rehabilitation

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, Learn About Clinical Studies.
Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Willing to sign informed consent prior to initiation of any study mandated procedure
- Male or female ≥ 40 years of age
- Women of childbearing potential must use a reliable method of contraception from screening until 1 month after end of study medication
-
Clinical diagnosis of moderate to severe COPD, with an obstructive pattern on pulmonary function tests showing both:
- FEV1/FVC < 0.7 and
- FEV1 ≤ 60% of predicted value, on standard COPD therapy
- Current or past smokers of ≥ 10 pack years
- If taking oral (< 20 mg/day of prednisone equivalent) or inhaled corticosteroids, inhaled beta-agonists (short and long acting), or inhaled muscarinic antagonists (short and long acting), or statins the dose must be stable for at least 30 days prior to initial PR visit.
- Ability to adequately participate in exercise testing/pulmonary rehabilitation program with supplemental oxygen use over the period of the study (in the best opinion of the investigator)
Exclusion Criteria:
-
Patients fulfilling one or more of the following criteria of documented COPD exacerbation within 1 months prior to screening:
- Use of antibiotics for COPD exacerbation
- Initiation or dose increase of steroids (inhaled, oral or intravenous) for COPD exacerbation
- Hospitalization for COPD exacerbation
- BMI > 40 kg/m2
- Unstable coronary artery disease, unstable angina, or myocardial infarction within 3 months prior to screening
- History of pulmonary edema, or uncontrolled heart failure
- Uncontrolled systemic hypertension with a blood pressure >180/105 mmHg at rest
- Systemic hypotension with systolic blood pressure < 85 mmHg
- Uncontrolled arrhythmias
- History of syncope
- Planned surgical intervention during the study period
- Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results including musculo-skeletal limitations, peripheral arterial disease, drug or alcohol dependence or psychiatric disease
- Severe hepatic impairment (Child-Pugh Class C)
- Chronic renal insufficiency, as defined by serum creatinine of > 2.5 mg/dL or estimated creatinine clearance < 30 mL/min or the requirement for dialysis
- Pregnant or nursing
- Currently (within 30 days prior to enrollment) taking specific pulmonary arterial hypertension therapy (e.g., bosentan, ambrisentan, tadalafil, sildenafil, epoprostenol, treprostinil, iloprost, beraprost), sildenafil and tadalafil for erectile dysfunction is permitted
- Initiation of a pulmonary rehabilitation program within 3 months prior to screening or initiation or changes during the study
- Participation in any other clinical trial, except observational, or receipt of an investigational medicinal product within 30 days prior to RHC visit
- Known concomitant life-threatening disease with a life expectancy < 6 months
- Known hypersensitivity to treprostinil or any of the excipients of the drug formulations.
- Known hypersensitivity to inhaled nitric oxide

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02178566
United States, Virginia | |
Inova Fairfax Medical Campus | |
Falls Church, Virginia, United States, 22042 |
Principal Investigator: | Steven Nathan, MD | Inova Fairfax Medical Campus | |
Principal Investigator: | Christopher King, MD | Inova Fairfax Medical Campus |
Documents provided by Inova Health Care Services:
Responsible Party: | Inova Health Care Services |
ClinicalTrials.gov Identifier: | NCT02178566 |
Other Study ID Numbers: |
Inova-TY-PR-001 |
First Posted: | July 1, 2014 Key Record Dates |
Results First Posted: | April 12, 2022 |
Last Update Posted: | April 12, 2022 |
Last Verified: | March 2022 |
COPD Trepostinil Pulmonary Rehabilitation |
Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive |
Respiratory Tract Diseases Treprostinil Antihypertensive Agents |