- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04461587
Examination of Pirfenidone (Esbriet®) Therapy in Coal Workers' Pneumoconiosis With Pulmonary Fibrosis
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 Disease, Reduction of Exacerbation Rates and Possible Reduction of Inflammatory Biomarkers as an Index of Clinical Response.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
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Virginia
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Abingdon, Virginia, United States, 24210
- Pulmonary Research of Abingdon, LLC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pirfenidone [Esbriet]
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:
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see previous entries
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Forced Vital Capacity (FVC)
Time Frame: 12 months minimum
|
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®).
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12 months minimum
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Forced Expiratory Volume in 1 second (FEV1)
Time Frame: 12 months minimum
|
rate of decline (relative change in % and ml )of FEV1 compared to baseline assessments established at enrollment.
|
12 months minimum
|
Diffusing capacity of the lung for carbon monoxide (DLCO)
Time Frame: 12 months minimum
|
rate of decline (relative change in %) of DLCO compared to baseline assessments established at enrollment.
|
12 months minimum
|
6 minute walk test
Time Frame: 12 months minimum
|
rate of decline of 6 minute walk test compared to baseline assessments established at enrollment.
|
12 months minimum
|
Chest CT
Time Frame: 12 months
|
Chest CT scans will be reviewed to determine if radiographic progression occurs during therapy.
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12 months
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Inflammatory biomarkers
Time Frame: 12 months minimum
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The reduction of inflammatory biomarkers (Interleukin-6 [IL-6], Transforming Growth Factor Beta 1 [TGF-β 1] and Tumor Necrosis Factor Alpha [TNF-α]) and the potential reduction correlation with change in lung function
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12 months minimum
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St. George's Respiratory Questionnaire (SGRQ)
Time Frame: 12 months minimum
|
Change in total score compared to baseline.
Total score summarizes the impact of the disease on overall health status.
Scores range from 0 - 100, with higher scores indicating more limitations.
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12 months minimum
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rates of Respiratory Exacerbation
Time Frame: 12 months minimum
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Change in exacerbation rate compared to 12 months prior to enrollment, including respiratory-related hospitalizations.
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12 months minimum
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Emory Robinette, MD, Pulmonary Research of Abingdon, LLC
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Lung Diseases
- Occupational Diseases
- Lung Diseases, Interstitial
- Lung Injury
- Pulmonary Fibrosis
- Pneumoconiosis
- Anthracosis
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Pirfenidone
Other Study ID Numbers
- ML42227
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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