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NCT05133453 | Not yet recruiting | Asbestosis

Pirfenidone Use in Asbestosis Patients: Efficacy and Prognosis
Sponsor:

Cairo University

Information provided by (Responsible Party):

Marwa Muhammad Fouad

Brief Summary:

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

Condition or disease

Asbestosis

Intervention/treatment

Pirfenidone

Phase

Not Applicable

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 Type : Interventional
Estimated Enrollment : 40 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : Pirfenidone Use in Asbestosis Patients: Efficacy and Prognosis
Actual Study Start Date : February 2024
Estimated Primary Completion Date : February 2025
Estimated Study Completion Date : February 2026
Arm Intervention/treatment

Active Comparator: Pirfinedone group

asbestosis patients given pirfenidone drug

No Intervention: Conventional group

Asbestosis patients on conventional treatment
Ages Eligible for Study: 18 Years to 60 Years
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: No
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.
Pirfenidone Use in Asbestosis Patients: Efficacy and Prognosis

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Pirfenidone Use in Asbestosis Patients: Efficacy and Prognosis

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