A Study to Assess Pulsed Inhaled Nitric Oxide in Subjects With Pulmonary Fibrosis at Risk for Pulmonary Hypertension

Phase 3 Terminated 145 enrolled Bellerophon Pulse Technologies

RandomizedParallel-groupQuadruple-blindTreatment

Summary

A randomized, double-blind, placebo-controlled dose escalation and verification study to assess the safety and efficacy of pulsed inhaled nitric oxide (iNO) in subjects at risk for pulmonary hypertension associated with pulmonary fibrosis on long term oxygen therapy (Part 1 and Part 2) - REBUILD

Timeline

Start: 2020-12-14
Primary completion: 2023-06-09
Completion: 2023-06-30

Outcome

Missed primary endpoint

Stopped: “The trial did not meet its primary endpoint, hence was terminated due to futility.”

paper in the iNO45 group and -3.7 min/d (3.76) in the placebo group (difference, 5.5; P = 0.265). PMID 39141673 ↗

Publications

Nathan SD, Rajicic N, Dudenhofer R, Hussain R, Argula R, Bandyopadhyay D, Luckhardt T, Muehlemann N, Flaherty KR, Glassberg MK, Lancaster L, Raghu G, Fernandes P. Inhaled Nitric Oxide in Fibrotic Lung Disease: A Randomized, Double-Blind, Placebo-controlled Trial. Ann Am Thorac Soc. 2024 Dec;21(12):1661-1669. doi: 10.1513/AnnalsATS.202406-662OC.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nitric Oxide	Other / unclassified	45 ug/kg	Inhaled