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Pirfenidone Use in Asbestosis Patients: Efficacy and Prognosis

Primary Purpose

Asbestosis

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Pirfenidone

About this trial

This is an interventional treatment trial for Asbestosis focused on measuring Pirfenidone, Asbestosis

Eligibility Criteria

18 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Male patients aged ≥ 18 years old
Patients who fulfilled investigations according the study protocol.
Patients who kept on follow up for the entire study.
All patients fulfilling the clinical and radiological criteria of asbestosis (Existence of asbestos-specific pleural changes in high resolution computed topography HRCT (pleural plaques), Reticular changes in HRCT and restrictive lung function pattern, History of asbestos exposure, Absence of an alternative explanation for fibrotic lung disease )
Clinically stable patients.
Patients who signed informed consent
Patients with mild-to-moderate IPF [forced vita capacity (FVC) ≥50% of predicted and diffusion capacity of carbon monoxide (DLCO) ≥30% of predicted].
Duration since diagnosis (at least one year before the study)

Exclusion Criteria:

Patients with peptic ulcer,
Severe hepatic disease, hepatitis C infection or any of the following liver function test criteria above specified limits: aspartate or alanine aminotransferase (AST or ALT) >2.5 u above upper limit of normal level.
Severe kidney disease, Cardiac disease, and Patients with other chronic pulmonary diseases, lung cancer
Presence of coexisting respiratory infection
History of alcohol or drugs abuse
Patients with neuromuscular disease,
Chronic renal failure,
Patient on oxygen therapy,
Life expectancy less than 6 months,
History of malignancy.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Pirfinedone group

Conventional group

Arm Description

asbestosis patients given pirfenidone drug

Asbestosis patients on conventional treatment

Outcomes

Primary Outcome Measures

Ventilatory function change

Absolute change in percent predicted forced vital capacity

Diffusion test

Diffusion test change from baseline

radiological findings change

radiological changes in High resolution computed topography.

Secondary Outcome Measures

Full Information

NCT ID

NCT05133453

First Posted

November 1, 2021

Last Updated

August 29, 2023

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT05133453

Brief Title

Pirfenidone Use in Asbestosis Patients: Efficacy and Prognosis

Official Title

Pirfenidone Use in Asbestosis Patients: Efficacy and Prognosis

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

February 2024 (Anticipated)

Primary Completion Date

February 2025 (Anticipated)

Study Completion Date

February 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

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.

5. Study Description

Brief Summary

This study aims at determining the the efficiency and prognosis of using pirfenidone drug among asbestosis patients.

Detailed Description

Asbestos exposure is associated with pleural and lung fibrosis and lung cancer. It has pathomechanisms and clinical similarities to interstitial pulmonary fibrosis disease. There is no definite cure for asbestosis. Pirfenidone has antifibrotic and anti-inflammatory effects.The safety and effectiveness of pirfenidone for the treatment of non-interstitial pulmonary fibrosis progressive fibrotic interstitial lung diseases remain unclear including asbestosis. Only few studies for pirfenidone use in asbestosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asbestosis

Keywords

Pirfenidone, Asbestosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pirfinedone group

Arm Type

Active Comparator

Arm Description

asbestosis patients given pirfenidone drug

Arm Title

Conventional group

Arm Type

No Intervention

Arm Description

Asbestosis patients on conventional treatment

Intervention Type

Drug

Intervention Name(s)

Pirfenidone

Other Intervention Name(s)

Conventional treatment

Intervention Description

drug intake three times daily for one year

Primary Outcome Measure Information:

Title

Ventilatory function change

Description

Absolute change in percent predicted forced vital capacity

Time Frame

after 6 months and 12 months from the start of the trial

Title

Diffusion test

Description

Diffusion test change from baseline

Time Frame

after 6 months and 12 months from the start of the trial

Title

radiological findings change

Description

radiological changes in High resolution computed topography.

Time Frame

after 6 months and 12 months from the start of the trial

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male patients aged ≥ 18 years old Patients who fulfilled investigations according the study protocol. Patients who kept on follow up for the entire study. All patients fulfilling the clinical and radiological criteria of asbestosis (Existence of asbestos-specific pleural changes in high resolution computed topography HRCT (pleural plaques), Reticular changes in HRCT and restrictive lung function pattern, History of asbestos exposure, Absence of an alternative explanation for fibrotic lung disease ) Clinically stable patients. Patients who signed informed consent Patients with mild-to-moderate IPF [forced vita capacity (FVC) ≥50% of predicted and diffusion capacity of carbon monoxide (DLCO) ≥30% of predicted]. Duration since diagnosis (at least one year before the study) Exclusion Criteria: Patients with peptic ulcer, Severe hepatic disease, hepatitis C infection or any of the following liver function test criteria above specified limits: aspartate or alanine aminotransferase (AST or ALT) >2.5 u above upper limit of normal level. Severe kidney disease, Cardiac disease, and Patients with other chronic pulmonary diseases, lung cancer Presence of coexisting respiratory infection History of alcohol or drugs abuse Patients with neuromuscular disease, Chronic renal failure, Patient on oxygen therapy, Life expectancy less than 6 months, History of malignancy.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marwa M Fouad, MD

Phone

01004531905

marwa.fouad@kasralainy.edu.eg

First Name & Middle Initial & Last Name or Official Title & Degree

Mohammed Elbatanouny, MD

Phone

01222174324

elbatanounym@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marwa M Fouad, MD

Organizational Affiliation

Cairo University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33798455

Citation

Behr J, Prasse A, Kreuter M, Johow J, Rabe KF, Bonella F, Bonnet R, Grohe C, Held M, Wilkens H, Hammerl P, Koschel D, Blaas S, Wirtz H, Ficker JH, Neumeister W, Schonfeld N, Claussen M, Kneidinger N, Frankenberger M, Hummler S, Kahn N, Tello S, Freise J, Welte T, Neuser P, Gunther A; RELIEF investigators. Pirfenidone in patients with progressive fibrotic interstitial lung diseases other than idiopathic pulmonary fibrosis (RELIEF): a double-blind, randomised, placebo-controlled, phase 2b trial. Lancet Respir Med. 2021 May;9(5):476-486. doi: 10.1016/S2213-2600(20)30554-3. Epub 2021 Mar 30.

Results Reference

result

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Pirfenidone Use in Asbestosis Patients: Efficacy and Prognosis

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