drugset

drugset / Trial / NCT01214187

Study of Inhaled Carbon Monoxide to Treat Idiopathic Pulmonary Fibrosis

NCT01214187 ↗

Phase 2 Completed 58 enrolled Brigham and Women's Hospital Columbia University · collab National Heart, Lung, and Blood Institute (NHLBI) · collab Tulane University · collab University of California, San Francisco · collab University of Chicago · collab University of Illinois at Chicago · collab University of Michigan · collab University of Washington · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to determine whether low concentration inhaled carbon monoxide is effective in treating idiopathic pulmonary fibrosis.

Timeline

Start: 2011-07
Primary completion: 2014-10
Completion: 2015-04

Outcome

Missed primary endpoint

registry analysis (superiority test); Carbon Monoxide Inhalation vs Oxygen 21%; p = 0.2072; Mean Difference (Net) -1.04; ANOVA NCT01214187 ↗

paper the change in MMP7 concentrations after 12 weeks of treatment did not significantly differ between the study arms PMID 29100885 ↗

Publications

Rosas IO, Goldberg HJ, Collard HR, El-Chemaly S, Flaherty K, Hunninghake GM, Lasky JA, Lederer DJ, Machado R, Martinez FJ, Maurer R, Teller D, Noth I, Peters E, Raghu G, Garcia JGN, Choi AMK. A Phase II Clinical Trial of Low-Dose Inhaled Carbon Monoxide in Idiopathic Pulmonary Fibrosis. Chest. 2018 Jan;153(1):94-104. doi: 10.1016/j.chest.2017.09.052. Epub 2017 Oct 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	carbon monoxide	Other / unclassified	100 ppm	Inhaled
Subject	carbon monoxide	Other / unclassified	200 ppm	Inhaled

Indications