Coal Workers' Pneumoconiosis (Complicated)Phase 2NCT04461587
Examination of Pirfenidone (Esbriet®) Therapy in Coal Workers' Pneumoconiosis With Pulmonary Fibrosis
A Phase 2 study testing Pirfenidone in people with Coal Workers' Pneumoconiosis (Complicated), run by Pulmonary Research of Abingdon, LLC at 1 site in United States.
Trial summary
Examination of pirfenidone (Esbriet®) therapy in coal workers' pneumoconiosis (black lung) with pulmonary fibrosis (scarring of the lung). Read more about this study
- Who is it for?
- Ages 40 to 79 years
- Conditions the study is for
- Coal Workers' Pneumoconiosis (Complicated)
- What is being tested?
- Pirfenidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2020to 16 Nov 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pulmonary Research of Abingdon, LLC
Abingdon, Virginia, 24210
About this study
Official title: 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.
Examination of pirfenidone (Esbriet®) therapy in coal workers' pneumoconiosis (black lung) with pulmonary fibrosis (scarring of the lung).
Read the 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 disease, reduction of exacerbation rates and possible reduction of inflammatory biomarkers as an index of clinical response.
- Being tested
- Pirfenidone
- Keywords
- Black Lung, Black Lung Disease, Coal Miner's Lung, Coal Worker's Pneumoconiosis, Coalworker's Pneumoconiosis, Pneumoconiosis, Coal Worker's
- Medical subject headings
- Anthracosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PirfenidoneDrug
Also called Esbriet
see previous entries
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Pirfenidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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®).
Measured: 12 months minimum
Secondary outcomes (6)
Forced Expiratory Volume in 1 second (FEV1)
rate of decline (relative change in % and ml )of FEV1 compared to baseline assessments established at enrollment.
Measured: 12 months minimum
Diffusing capacity of the lung for carbon monoxide (DLCO)
rate of decline (relative change in %) of DLCO compared to baseline assessments established at enrollment.
Measured: 12 months minimum
6 minute walk test
rate of decline of 6 minute walk test compared to baseline assessments established at enrollment.
Measured: 12 months minimum
Chest CT
Chest CT scans will be reviewed to determine if radiographic progression occurs during therapy.
Measured: 12 months
Inflammatory biomarkers
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
Measured: 12 months minimum
St. George's Respiratory Questionnaire (SGRQ)
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.
Measured: 12 months minimum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start31 Aug 2020
- Primary completion10 Nov 2022
- Study completion16 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coal Workers' Pneumoconiosis (Complicated)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label interventional study observing US FDA approved Esbriet (for Interstitial Pulmonary Fibrosis) in Coal Workers' Pneumoconiosis patients with pulmonary fibrosis.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pulmonary Research of Abingdon, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Emory Robinette, MD, Principal investigator, Pulmonary Research of Abingdon, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04461587
- Sponsor's protocol ID
- ML42227
- Status last verified
- Jul 2024
- First submitted
- 26 Jun 2020
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT04461587
- Acronym / sponsor ID
- ML42227
- Keywords
- Black Lung, Black Lung Disease, Coal Miner's Lung, Coal Worker's Pneumoconiosis, Coalworker's Pneumoconiosis, Pneumoconiosis, Coal Worker's
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Pulmonary Research of Abingdon, LLCUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- 10 Nov 2022 (actual)
- Study completion
- 16 Nov 2022 (actual)
- First posted
- 8 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 disease, reduction of exacerbation rates and possible reduction of inflammatory biomarkers as an index of clinical response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label interventional study observing US FDA approved Esbriet (for Interstitial Pulmonary Fibrosis) in Coal Workers' Pneumoconiosis patients with pulmonary fibrosis.
| Arm | Type | Receives |
|---|---|---|
| Pirfenidone [Esbriet] | Experimental | Drug: PirfenidonePirfenidone 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. |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PirfenidoneAlso: Esbrietsee previous entries | Drug | Pirfenidone [Esbriet] |
Primary outcome
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®).
6 secondary outcomes
Forced Expiratory Volume in 1 second (FEV1)
Time frame: 12 months minimum
Diffusing capacity of the lung for carbon monoxide (DLCO)
Time frame: 12 months minimum
6 minute walk test
Time frame: 12 months minimum
Chest CT
Time frame: 12 months
Inflammatory biomarkers
Time frame: 12 months minimum
St. George's Respiratory Questionnaire (SGRQ)
Time frame: 12 months minimum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- European Journal of Respiratory Medicine Journal ArticleLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emory Robinette, MD principal investigator
Pulmonary Research of Abingdon, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pirfenidone in people with Coal Workers' Pneumoconiosis (Complicated), run by Pulmonary Research of Abingdon, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced Vital Capacity (FVC) (time frame: 12 months minimum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.