Pirfenidone Use in Asbestosis Patients: Efficacy and Prognosis

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05133453
Collaborator
(none)
40
2
17.9

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pirfenidone Use in Asbestosis Patients: Efficacy and Prognosis
Anticipated Study Start Date :
Feb 1, 2022
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Pirfinedone group

asbestosis patients given pirfenidone drug

Drug: Pirfenidone
drug intake three times daily for one year
Other Names:
  • Conventional treatment
  • No Intervention: Conventional group

    Asbestosis patients on conventional treatment

    Outcome Measures

    Primary Outcome Measures

    1. Ventilatory function change [after 6 months and 12 months from the start of the trial]

      Absolute change in percent predicted forced vital capacity

    2. Diffusion test [after 6 months and 12 months from the start of the trial]

      Diffusion test change from baseline

    3. radiological findings change [after 6 months and 12 months from the start of the trial]

      radiological changes in High resolution computed topography.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Principal Investigator: Marwa M Fouad, MD, Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Marwa Mohammed Fouad, Lecturer of Occupational and environmental Medicine, Cairo University
    ClinicalTrials.gov Identifier:
    NCT05133453
    Other Study ID Numbers:
    • Pirfenidone in asbestosis
    First Posted:
    Nov 24, 2021
    Last Update Posted:
    Nov 30, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Marwa Mohammed Fouad, Lecturer of Occupational and environmental Medicine, Cairo University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 30, 2021