Pulmonary Rehab in Chronic Obstructive Pulmonary Disease (COPD): Response to Tyvaso

• Status: Terminated
• Trial end date: 2019-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Inova Health Care Services
• Treatments: Treprostinil

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