At a glance
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The Effect of Sodium Pyruvate Nasal Spray on Coughing in Patients With Idiopathic Pulmonary Fibrosis
In Brief
A Phase 3 clinical trial evaluating 20mM sodium pyruvate nasal spray and Saline Placebo control nasal spray for Idiopathic Pulmonary Fibrosis. Completed, enrolled 50 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
The product is a 20 mM (0.2%, 2.2 mg/mL) sodium pyruvate nasal spray in 0.9% sodium chloride with benzalkonium chloride preservative, pH 7.2 (N115). Subjects will self-administer 3 squirts per nostril of the nasal spray, 3 times daily; upon wakening, noon/midday, and before bedtime.
The placebo is 0.9% sodium chloride with benzalkonium chloride preservative, pH 7.2. Subjects will self-administer 3 squirts per nostril of the nasal spray, 3 times daily; upon wakening, noon/midday, and before bedtime.