Inhaled Sodium Nitrite as an Antimicrobial for Cystic Fibrosis

Stopped early · Phase 1/Phase 2

Conditions studied: Cystic Fibrosis

In brief

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.

Key facts

Study ID

NCT02694393

Run by

Schmidhofer, Mark, MD

People needed

4

Starts

2016-02-01

Expected to finish

2022-07-21

Last updated by the study team

2024-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Cystic Fibrosis as documented by clinical features, and documentation of a positive sweat test or two disease causing mutation of the CF gene.

You may not qualify if…

• use of supplemental oxygen, FEV1 < 40% predicted, inability to discontinue inhaled antibiotics for 4 weeks,
• hospitalization within 4 weeks prior to enrollment,
• change in maintenance CF therapies within 4 weeks of enrollment,
• severe anemia, significant chronic liver disease, severe pulmonary hypertension, prior organ transplantation

Where it is running

• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Comprehensive Lung Center - Falk Clinic — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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