The Effect of N115 on Coughing in IPF Patients

Prior treatment

• Pregnancy (urine pregnancy test will be performed prior to enrollment).
• 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 who have taken dietary supplements containing pyruvate within 24 hours prior to the screening visit.

Other illness

• 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.
• Hospitalization within last 6 months due to acute exacerbation of airway disease.
• Subjects with a current history of alcohol or recreational drug abuse.
• Subjects with metabolic diseases (diabetes, hypoglycemia, etc.).

Age

• Females of childbearing potential age not on adequate contraception or lactating females.
• Subjects less than 18 years of age.

Other

• Subjects with a clinically significant abnormal chest X-ray within past 12 months.

• 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.