Inhaled Sodium Nitrite as an Antimicrobial for Cystic Fibrosis

Phase 1/2 Terminated 4 enrolled Schmidhofer, Mark, MD Cystic Fibrosis Foundation · collab Mast Therapeutics, Inc. · collab

NaSingle-groupOpen-labelTreatment

Summary

This study will assess the safety of inhaled sodium nitrite in adults with Cystic Fibrosis and chronic Pseudomonas infections, and determine the ability of sodium nitrite to reduce the burden of Pseudomonas.

Timeline

Start: 2016-02
Primary completion: 2022-07-21
Completion: 2022-07-21

Outcome

Outcome not reported

Stopped (Enrollment): “Protocol closed due to difficulty recruiting subjects and then expiration of investigational product and lack of a manufacturer.”

Publications

Background Major TA, Panmanee W, Mortensen JE, Gray LD, Hoglen N, Hassett DJ. Sodium nitrite-mediated killing of the major cystic fibrosis pathogens Pseudomonas aeruginosa, Staphylococcus aureus, and Burkholderia cepacia under anaerobic planktonic and biofilm conditions. Antimicrob Agents Chemother. 2010 Nov;54(11):4671-7. doi: 10.1128/AAC.00379-10. Epub 2010 Aug 9.
Background Zemke AC, Shiva S, Burns JL, Moskowitz SM, Pilewski JM, Gladwin MT, Bomberger JM. Nitrite modulates bacterial antibiotic susceptibility and biofilm formation in association with airway epithelial cells. Free Radic Biol Med. 2014 Dec;77:307-16. doi: 10.1016/j.freeradbiomed.2014.08.011. Epub 2014 Sep 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sodium Nitrite	Small molecule	46 mg	Inhaled
Subject	Sodium Nitrite	Small molecule	80 mg	Inhaled