A Dose Escalation Study to Assess the Safety and Efficacy of Pulsed Inhaled Nitric Oxide in Subje… (NCT03727451) | Clinical Trial Compass
CompletedPhase 2
A Dose Escalation Study to Assess the Safety and Efficacy of Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Fibrosis or Sarcoidosis
United States17 participantsStarted 2019-01-30
Plain-language summary
A phase 2b, open label study to assess the safety and efficacy of increasing doses of pulsed, inhaled nitric oxide (iNO) in subjects with pulmonary fibrosis and sarcoidosis on long term oxygen therapy followed by a long term extension study
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. Signed informed consent
✓. A primary diagnosis of sarcoidosis as defined by the ATS/ERS/WASOG statement or pulmonary fibrosis associated with one of the following conditions:
✓.1 Major IIPs (idiopathic interstitial pneumonias) diagnosed or suspected as one of the following:
✓.2 Chronic hypersensitivity pneumonitis
✓.3 Occupational lung disease
✓.4 Connective tissue disease with evidence of significant pulmonary fibrosis
✓. Intermediate or high probability of PH by echocardiogram as assessed by local Radiologist/Investigator, or PH as determined by a right heart catheterization (RHC) within 5 years prior to Baseline with the following parameters:
✕. On more than 6 L/min of oxygen at rest by nasal cannula for less than 4 weeks
✕. Evidence of any connective tissue disease with FVC \> 60% in the last 6 months prior to screening unless there is evidence of moderate to severe fibrosis on CT scan in the opinion of the local radiologist/Investigator
✕. Evidence of clinically significant combined pulmonary fibrosis with emphysema (CPFE) if \> 15% of lung fields by CT scan show evidence of emphysema in the opinion of the local radiologist/Investigator