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 @ 5:25 PM
Ignite Modification Date:
2025-12-24 @ 5:25 PM
NCT ID:
NCT00403650
Eligibility Criteria:
Inclusion Criteria:
* Patients with known sarcoidosis 17
* Age 18 or greater
* Patients with documented pulmonary hypertension with a PA mean \> 25 mm as measured by cardiac catheterization within six months of entry into the study
* Patients with dyspnea
* Six minute walk distance of between 100 to 500 meters
* Patients on stable immunotherapy for their sarcoidosis, including prednisone, methotrexate, azathioprine, hydroxychloroquine, cyclophosphamide, thalidomide, and/or infliximab
* Patients able to provide written consent
Exclusion Criteria:
* Patients on pulmonary vasodilator drugs (flolan, remodulin, bosentan, sildenafil) in the prior 28 days (patients on stable dose of calcium channel blocker for more than 1 month prior to right heart catheterization can be continued on the calcium channel blocker)
* Patients with severe airway obstruction as defined by FEV1/FVC of less than 35%
* Patients with World Health Organization (WHO) class IV status
* Patients who are pregnant or breast feeding
* Patients with significant left ventricular dysfunction with a left ventricular ejection fraction of less than 35%
* Significant liver dysfunction not due to sarcoidosis
* Patients with severe other organ disease felt by investigators to impact survival during the course of the study
* Patients unable to perform the 6 inhalation treatments required for therapy
* Patients with \< 90 mm Hg Systolic systemic blood pressure will be excluded
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT00403650
Study Brief:
Protocol Section:
NCT00403650