Examination of Pirfenidone (Esbriet®) Therapy in Coal Workers' Pneumoconiosis With Pulmonary Fibr… (NCT04461587) | Clinical Trial Compass
CompletedPhase 2
Examination of Pirfenidone (Esbriet®) Therapy in Coal Workers' Pneumoconiosis With Pulmonary Fibrosis
United States50 participantsStarted 2020-08-31
Plain-language summary
Examination of pirfenidone (Esbriet®) therapy in coal workers' pneumoconiosis (black lung) with pulmonary fibrosis (scarring of the lung).
Who can participate
Age range40 Years – 79 Years
SexALL
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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…