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

NCT04461587 | Completed Phase 2 FDA Drug

• 1 other identifier: ML42227
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Coal Workers' Pneumoconiosis (Complicated)

Keywords

Black Lung; Black Lung Disease; Coal Miner's Lung; Coal Worker's Pneumoconiosis; Coalworker's Pneumoconiosis; Pneumoconiosis, Coal Worker's

Outcome Measures

Primary Outcomes (1)

• Forced Vital Capacity (FVC)

  Primary objective for this study is to determine the rate of decline ( relative change in FVC (% and ml) in patients with coal workers' pneumoconiosis (Black Lung) with pulmonary fibrosis (CWP/PMF) during treatment with pirfenidone (Esbriet®).

  12 months minimum

Secondary Outcomes (6)

• Forced Expiratory Volume in 1 second (FEV1)

  12 months minimum

• Diffusing capacity of the lung for carbon monoxide (DLCO)

  12 months minimum

• 6 minute walk test

  12 months minimum

• Chest CT

  12 months

• Inflammatory biomarkers

  12 months minimum

Other Outcomes (1)

• Rates of Respiratory Exacerbation

  12 months minimum

Study Arms (1)

Pirfenidone [Esbriet]

EXPERIMENTAL

Pirfenidone recommended daily dose for patients is 801 mg three times a day with food, for a total of 2403 mg/day. Upon initiating treatment, the dose should be titrated to the recommended daily dose of 2403 mg/day over a 14day period as follows: * Days 1 to 7: a dose of 267 mg administered three times a day (801 mg/day) * Days 8 to 14: a dose of 534 mg administered three times a day (1602 mg/day) * Day 15 onward: a dose of 801 mg administered three times a day (2403 mg/day) It will be provided in 267mg capsules. Treatment will be for a minimum of 12 months. Treatment duration will continue until last patient enrolled received 12 months of treatment.

Drug: Pirfenidone

Interventions

Pirfenidone DRUG

see previous entries

Also known as: Esbriet

Pirfenidone [Esbriet]

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Able and willing to provide informed consent and to comply with study protocol
• \. Coal miners between the ages 40 to 79 years of age at visit 1with a minimum of 15 years in a coal mining environment
• \. 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.
• \. 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.
• \. 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.
• \. 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.

You may not qualify if:

• \. History of prior therapy with Esbriet or Ofev (pirfenidone or nintedanib)
• \. Recent hospitalization (within 30 days prior to screening) for respiratory decompensation.
• \. 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.
• \. Elevation of liver function test at screening documenting AST, ALT or total bilirubin \> 3 x ULN or ALP \> 2.5 x ULN.
• \. Patients who have other pulmonary pathology such as lung cancer, active tuberculosis or atypical mycobacterial infection requiring treatment.
• \. 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.
• \. 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
• \. Use of any investigational therapy within 4 weeks of enrollment.
• \. 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.
• \. Individuals with poorly controlled diabetes per PI discretion (Hemoglobin A1c \>9). Historical values will be accepted.
• \. Pregnancy or lactation.

Sponsors & Collaborators

• Pulmonary Research of Abingdon, LLC: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Pulmonary Research of Abingdon, LLC

Abingdon, Virginia, 24210, United States

Location

Related Links

• European Journal of Respiratory Medicine Journal Article

MeSH Terms

Conditions

Anthracosis

Interventions

pirfenidone

Condition Hierarchy (Ancestors)

Pneumoconiosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Lung Injury

Study Officials

• Emory Robinette, MD

  Pulmonary Research of Abingdon, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label interventional study observing US FDA approved Esbriet (for Interstitial Pulmonary Fibrosis) in Coal Workers' Pneumoconiosis patients with pulmonary fibrosis.

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: July 8, 2020
• Study Start: August 31, 2020
• Primary Completion: November 10, 2022
• Study Completion: November 16, 2022
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)