Examination of Pirfenidone (Esbriet®) Therapy in Coal Workers' Pneumoconiosis With Pulmonary Fibrosis

• Status: Recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Examination of pirfenidone (Esbriet®) therapy in coal workers' pneumoconiosis (black lung) with pulmonary fibrosis (scarring of the lung).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pulmonary Research of Abingdon, LLC
• Collaborator: Genentech, Inc.
• Treatments: Pirfenidone

Criteria

Inclusion Criteria:

• 1. Able and willing to provide informed consent and to comply with study protocol

• 2. Coal miners between the ages 40 to 79 years of age at visit 1with a minimum of 15 years in a coal mining environment

• 3. Chest CT Scan or Chest Xray (within 6 months) confirming diagnosis of CWP, complicated black lung disease/progressive massive fibrosis will be recorded. If CT not available must be obtained at Visit 1.

• 4. Evidence of Loss of lung function defined by decline in FEV1 or FVC or DLCO of 5% within the past 36 months prior to enrollment.

• 5. FEV1 ≤ 75% or FVC ≤ 80% or DLCO ≤ 70% or abnormal 6MWT with oxygen desaturation of 4% or greater than resting at screening or within past 6 months.

• 6. Former smokers and current smokers will be enrolled if documented evidence of CWP/PMF is present and meet PFT guidelines. Current smokers will be given smoking cessation counseling at each visit due to the effect on pirfenidone concentration and efficacy.

Exclusion Criteria:

• 1. History of prior therapy with Esbriet or Ofev (pirfenidone or nintedanib)

• 2. Recent hospitalization (within 30 days prior to screening) for respiratory decompensation.

• 3. Patients using monoclonal antibody therapy or immunosuppressive therapy for other disease process will be excluded, except for the following:

• Daily prednisone up to 10 mg daily (prescribed for lung disease or rheumatoid arthritis) will be permitted. Chronic use for 3 months prior to enrollment will be documented.

• Methotrexate for rheumatoid arthritis will be permitted as long as chronic use for 6 months prior to enrollment is documented.

• 4. Elevation of liver function test at screening documenting AST, ALT or total bilirubin > 3 x ULN or ALP > 2.5 x ULN.

• 5. Patients who have other pulmonary pathology such as lung cancer, active tuberculosis or atypical mycobacterial infection requiring treatment.

• 6. Patients with recurrent malignancy requiring chemotherapy or radiation therapy. Individuals with a prior diagnosis of localized skin cancer, prostate cancer, localized bladder cancer will not be excluded unless undergoing active treatment. Patients with a prior diagnosis of malignancy treated greater than 5 years ago will be considered for enrollment.

• 7. History of alcohol or drug abuse that would impair or risk the patient's full participation in the drug study in the opinion of the investigator

• 8. Use of any investigational therapy within 4 weeks of enrollment.

• 9. Individuals with clinically significant unstable cardiac disease (ejection fraction ≤35%) or complex arrhythmias per PI discretion. Chronic atrial fibrillation will be permitted if heart rate is controlled. Historical values of ejection fraction will be accepted.

• 10. Individuals with poorly controlled diabetes per PI discretion (Hemoglobin A1c >9). Historical values will be accepted.

• 11. Pregnancy or lactation.