This is a Phase 3, randomized, double-blind, placebo-controlled dose escalation study to assess the safety and efficacy of pulsed INOpulse versus placebo in study participants with fibrotic interstitial lungdisease (fILD) on oxygen therapy, and thus are considered at risk of having or developing pulmonary hypertension (PH) associated with pulmonary fibrosis (PF).
Inclusion Criteria
1. Have been using oxygen therapy (including use limited to exertion) at ≤ 10 L/min of oxygen supplementation by nasal cannula for at least 4 weeks prior to the Screening Run-In period.
2. 6MWD ≥ 100 meters and ≤ 400 meters at screening and Baseline/Randomization visits.
3. WHO Functional Class II-IV.
Exclusion Criteria
1. Administered L-arginine within 1 week prior to Screening.
2. The concurrent use of the INOpulse device with a continuous positive airway pressure (CPAP), Bilevel positive airway pressure (BiPAP), or any other positive pressure device.
3. Use of investigational drugs or devices within 1 month prior to Screening.
Study Requirements
inded treatment period was 8 weeks for Cohort 1 and 16 weeks for Cohort 2; Blood will be taken at Visits 1, 3 5, and 7. A CT scan will be conducted at Visit 1.
