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Anti-fibrotic agent

Pirfenidone for Black Lung Disease

Phase 2
Waitlist Available
Led By Emory Robinette, MD
Research Sponsored by Pulmonary Research of Abingdon, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial is testing whether pirfenidone can help treat black lung disease by reducing the amount of scarring in the lungs.

Eligible Conditions
  • Black Lung Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Forced Vital Capacity (FVC)
Secondary outcome measures
6 minute walk test
Cognitive Therapy
Diffusing capacity of the lung for carbon monoxide (DLCO)
+3 more
Other outcome measures
Rates of Respiratory Exacerbation

Side effects data

From 2019 Phase 3 trial • 60 Patients • NCT03208933
27%
Nausea
22%
Decreased appetite
13%
Vomiting
13%
Dyspepsia
12%
Diarrhoea
10%
Dyspnoea
7%
Pruritus
7%
Weight decreased
7%
Cough
3%
Idiopathic pulmonary fibrosis
3%
Death
2%
Bronchitis chronic
2%
Bronchitis bacterial
2%
Cholecystitis infective
2%
Atrial flutter
2%
Pneumonia
2%
Adenocarcinoma of colon
2%
Sudden cardiac death
2%
Atrial fibrillation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pirfenidone

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pirfenidone [Esbriet]Experimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pirfenidone
2006
Completed Phase 3
~2630

Find a Location

Who is running the clinical trial?

Pulmonary Research of Abingdon, LLCLead Sponsor
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
568,093 Total Patients Enrolled
Emory Robinette, MDPrincipal InvestigatorPulmonary Research of Abingdon, LLC

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum patient limit for this clinical trial?

"No, this study is not enrolling patients presently. The posting for the clinical trial was first made on 8/31/2020 and was most recently edited on 4/21/2022. If you are searching for other studies, there are 106 trials actively looking for participants with bagassosis and 15 trials for Pirfenidone admitting patients."

Answered by AI

For which demographics is this clinical trial designed?

"Patients that have bagassosis and are between 40-79 years old may be eligible for this study, of which approximately 50 individuals will be accepted."

Answered by AI

Does this scientific experiment represent a new development in research?

"Since 2015, there has been an ongoing effort to study the efficacy of Pirfenidone. In fact, the first ever trial was conducted by Shanghai Genomics, Inc.. After this initial 48-person study yielded positive results, Phase 2 drug approval was granted. Presently, there are 15 active studies involving 11 cities and 8 countries."

Answered by AI

Are there any harmful side effects associated with Pirfenidone?

"Pirfenidone has been evaluated in Phase 2 clinical trials, so there is some safety data but no efficacy data. Our team at Power estimates the safety to be a 2."

Answered by AI

Are researchers still enrolling patients in this clinical trial?

"Unfortunately, this trial is no longer recruiting patients. The study was first posted on 8/31/2020, and the most recent update was on 4/21/2022. However, there are 106 other trials for bagassosis and 15 for Pirfenidone that are still looking for participants."

Answered by AI

Does this test only include people who are under 45 years old?

"This particular clinical trial only enrolls patients aged 40 to 79. Contrastingly, there are 7 other studies for patients under 18 and 113 for those over 65."

Answered by AI

Is this the first time Pirfenidone has been trialed?

"15 clinical trials are currently underway to research Pirfenidone's efficacy, with 1 trial in the last stages. Most of these studies are based in Mayaguez, Pennsylvania; although, there are a total of 32 locations conducting these medical investigations."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Examination of Pirfenidone (Esbriet®) Therapy in Coal Workers' Pneumoconiosis With Pulmonary Fibrosis
2020. "Examination of Pirfenidone (Esbriet®) Therapy in Coal Workers' Pneumoconiosis With Pulmonary Fibrosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04461587.
~11 spots leftby Apr 2025
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