Status:
COMPLETED
The Effect of N115 on Coughing in IPF Patients
Lead Sponsor:
Cellular Sciences, inc.
Collaborating Sponsors:
Family First Medical Research Center
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
40-80 years
Phase:
PHASE3
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 t...
Detailed Description
Idiopathic pulmonary fibrosis (IPF) belongs to a group of conditions called interstitial lung diseases (also known as ILD), which describes lung diseases that involve inflammation or scarring in the l...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.).
Key Trial Info
Start Date :
August 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 20 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06037408
Start Date
August 15 2023
End Date
May 20 2024
Last Update
August 7 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Family First Medical Research Center
Hialeah Gardens, Florida, United States, 33016