The Effect of N115 on Coughing in IPF Patients

Summary

The purpose of this clinical trial is to administer a sodium pyruvate nasal spray that eliminates nasal oxidative stresses, caused by oxygen radicals, and demonstrate the efficacy of sodium pyruvate to reduce coughing and increase lung functions in patients with idiopathic pulmonary fibrosis. This will be a 21-day double-blinded randomized placebo-controlled trial designed to determine if patients with idiopathic pulmonary fibrosis treated with 20mM sodium pyruvate in 0.9% sodium chloride nasal spray solution will have reduced chronic coughing, as well as increased lung function (FEV1, FVC endpoints of 12% or more within the first week) and improved FEV1/FVC ratios.

Timeline

Start

2023-08-15

Primary completion

2024-05-16

Completion

2024-05-20

Outcome

Met primary endpoint

registry analysis (superiority test); 20mM Sodium Pyruvate Nasal Spray Treatment vs Saline Placebo Control; p = 0.0001; Mean Difference (Final Values) -57.13 (95% CI -63.99 to -50.27); ANOVA NCT06037408 ↗

Publications

• Background Wells AU. The revised ATS/ERS/JRS/ALAT diagnostic criteria for idiopathic pulmonary fibrosis (IPF)--practical implications. Respir Res. 2013;14 Suppl 1(Suppl 1):S2. doi: 10.1186/1465-9921-14-S1-S2. Epub 2013 Apr 16.

Drugs

Indications