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NCT06037408

The Effect of N115 on Coughing in IPF Patients

The Effect of Sodium Pyruvate Nasal Spray on Coughing in Patients With Idiopathic Pulmonary Fibrosis
Cellular Sciences, inc.·Phase 3·ClinicalTrials.gov·drugRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Idiopathic Pulmonary Fibrosis
Drug/Device/Intervention
20mM sodium pyruvate nasal spray
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Cellular Sciences, inc.
Location
Hialeah Gardens, United States of America
Timeline & enrollment
Phase
Phase 3
Start date
Aug 15, 2023
End date
Aug 31, 2024
Enrollment
50 participants
Primary outcome

Coughing

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.

ICD-10 classifications
Other interstitial pulmonary diseases with fibrosisCystic fibrosis with pulmonary manifestationsCystic fibrosisGraphite fibrosis (of lung)Pulmonary heart disease, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06037408
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06037408 through Pure Global AI's free database. This Phase 3 trial is sponsored by Cellular Sciences, inc. and is currently Recruiting. The study focuses on Idiopathic Pulmonary Fibrosis. Target enrollment is 50 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.