Pulmonary Rehab in Chronic Obstructive Pulmonary Disease (COPD): Response to Tyvaso
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Inhaled Treprostinil
Intervention description: 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 .
Intervention MeSH terms: Treprostinil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD; Trepostinil; Pulmonary Rehabilitation

Summary:

      The investigators' hypothesis is that pretreating patients with COPD with inhaled
      treprostinil prior to pulmonary rehabilitation sessions will result in improved exercise
      tolerance during sessions. This in turn will lead to an increased response to pulmonary
      rehabilitation, resulting in improved exercise tolerance and quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Willing to sign informed consent prior to initiation of any study mandated procedure

          2. Male or female ≥ 40 years of age

          3. Women of childbearing potential must use a reliable method of contraception from
             screening until 1 month after end of study medication

          4. 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

          5. Current or past smokers of ≥ 10 pack years

          6. 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.

          7. 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:

          1. 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

          2. BMI > 40 kg/m2

          3. Unstable coronary artery disease, unstable angina, or myocardial infarction within 3
             months prior to screening

          4. History of pulmonary edema, or uncontrolled heart failure

          5. Uncontrolled systemic hypertension with a blood pressure >180/105 mmHg at rest

          6. Systemic hypotension with systolic blood pressure < 85 mmHg

          7. Uncontrolled arrhythmias

          8. History of syncope

          9. Planned surgical intervention during the study period

         10. 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

         11. Severe hepatic impairment (Child-Pugh Class C)

         12. 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

         13. Pregnant or nursing

         14. 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

         15. Initiation of a pulmonary rehabilitation program within 3 months prior to screening or
             initiation or changes during the study

         16. Participation in any other clinical trial, except observational, or receipt of an
             investigational medicinal product within 30 days prior to RHC visit

         17. Known concomitant life-threatening disease with a life expectancy < 6 months

         18. Known hypersensitivity to treprostinil or any of the excipients of the drug
             formulations.

         19. Known hypersensitivity to inhaled nitric oxide