Phase I/II Study of Inhaled Sodium Nitrite as an Antimicrobial for Pseudomonas Infection in Cystic Fibrosis

PRO15040062

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.

2016-02-01

2022-07-21

2022-07-21

Terminated

Early phase I

4

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 4, 'type': 'ACTUAL'}}

2024-06-24