The Effect of N115 on Coughing in IPF Patients

NCT06037408 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: Pro00072822
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• Percent Change in Coughing Episodes Per Day From Baseline to Day 21.

  Percent change in coughing was calculated by subtracting the baseline coughs per day from the day 21 coughs per day and then dividing by the baseline coughs per day. The a priori threshold was set at a 25% or greater decrease. (An episode is defined as 5 or more coughs per hour.)

  21 days

Secondary Outcomes (1)

• Percent Change in FEV1/FVC Ratios From Baseline to Day 21.

  21 days

Study Arms (2)

20mM sodium pyruvate nasal spray treatment

EXPERIMENTAL

Drug: 20mM sodium pyruvate nasal spray

Saline placebo control

PLACEBO COMPARATOR

Other: Saline Placebo control nasal spray

Interventions

20mM sodium pyruvate nasal spray DRUG

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.

20mM sodium pyruvate nasal spray treatment

Saline Placebo control nasal spray OTHER

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.

Saline placebo control

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals with a clinical diagnosis of idiopathic pulmonary fibrosis in accordance with the most recent collaborative guidelines from the American Thoracic Society, the European Respiratory Society, the Japanese Respiratory Society, and the Latin American Thoracic Association including HRCT scan and/or lung biopsy consistent with unusual interstitial pneumonia (UIP), especially honeycombing, without identifiable cause related to other ILD such as drug toxicity, occupational or environmental exposure or connective tissue disease.
• condition-related cough.
• Mild to moderate FEV1 and FVC at 50% or greater of standard
• Individuals who agree to abstain from sexual intercourse, or agree to use condoms or vaginal diaphragms or other devices designed to prevent contraception, during the entire course of the study.

You may not qualify if:

• Pulmonary disease other than idiopathic pulmonary fibrosis.
• Respiratory infections in the last 2 weeks.
• Clinically significant cardiac disease including uncontrolled congestive heart failure and unstable angina.
• Pregnancy (urine pregnancy test will be performed prior to enrollment).
• Females of childbearing potential age not on adequate contraception or lactating females.
• Subjects less than 18 years of age.
• Hospitalization within last 6 months due to acute exacerbation of airway disease.
• Subjects with a clinically significant abnormal chest X-ray within past 12 months.
• Medication changes within 1 month of study entry except for antiviral, antibiotic, or antimicrobial medications as well as corticosteroids, antihistamines, or anti-inflammatory medications.
• Subjects who have participated in another drug treatment study within the last month.
• Subjects with a current history of alcohol or recreational drug abuse.
• Subjects who have taken dietary supplements containing pyruvate within 24 hours prior to the screening visit.
• Subjects with metabolic diseases (diabetes, hypoglycemia, etc.).

Sponsors & Collaborators

• Cellular Sciences, inc.: lead
• Family First Medical Research Center: collaborator

Study Sites (1)

Family First Medical Research Center

Hialeah Gardens, Florida, 33016, United States

Location

Related Publications (1)

• 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.

  PMID: 23734820 BACKGROUND

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Alain Martin
• Organization: Emphycorp, Inc.

al.martin.hq@emphycorp.com

(908) 237-1561

Study Officials

• Manuel M Lam, MD

  Family First Medical Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: September 14, 2023
• Study Start: August 15, 2023
• Primary Completion: May 16, 2024
• Study Completion: May 20, 2024
• Last Updated: August 7, 2024
• Results First Posted: July 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)