Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2025-12-24 @ 4:43 PM
NCT ID:
NCT02178566
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT02178566
Study Brief:
Protocol Section:
NCT02178566