Status:
COMPLETED
Examination of Pirfenidone (Esbriet®) Therapy in Coal Workers' Pneumoconiosis With Pulmonary Fibrosis
Lead Sponsor:
Pulmonary Research of Abingdon, LLC
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Coal Workers' Pneumoconiosis (Complicated)
Eligibility:
All Genders
40-79 years
Phase:
PHASE2
Brief Summary
Examination of pirfenidone (Esbriet®) therapy in coal workers' pneumoconiosis (black lung) with pulmonary fibrosis (scarring of the lung).
Detailed Description
Examination of pirfenidone (Esbriet®) therapy in coal workers' pneumoconiosis with pulmonary fibrosis associated with radiographic and functional impairment to examine the reduction in progression of ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 16 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04461587
Start Date
August 31 2020
End Date
November 16 2022
Last Update
July 16 2024
Active Locations (1)
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1
Pulmonary Research of Abingdon, LLC
Abingdon, Virginia, United States, 24210