drugset / Trial / NCT02694393
Inhaled Sodium Nitrite as an Antimicrobial for Cystic Fibrosis
Phase 1/2
Terminated
4 enrolled
Schmidhofer, Mark, MD
Cystic Fibrosis Foundation · collabMast 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
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 |