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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Forced Vital Capacity (FVC)

Secondary study objectives

6 minute walk test

Cognitive Therapy

Diffusing capacity of the lung for carbon monoxide (DLCO)

+3 more

Other study objectives

Rates of Respiratory Exacerbation

Side effects data

From 2019 Phase 3 trial • 60 Patients • NCT03208933

27%

Nausea

22%

Decreased appetite

13%

Dyspepsia

13%

Vomiting

12%

Diarrhoea

10%

Dyspnoea

Cough

Weight decreased

Pruritus

Idiopathic pulmonary fibrosis

Death

Bronchitis chronic

Sudden cardiac death

Atrial fibrillation

Atrial flutter

Bronchitis bacterial

Cholecystitis infective

Pneumonia

Adenocarcinoma of colon

100%

80%

60%

40%

20%

Study treatment Arm

Pirfenidone

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2600

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