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Pirfenidone Use in Asbestosis Patients: Efficacy and Prognosis

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 60 Years
Gender	Male

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05133453
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Cairo University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Marwa M Fouad, MD
Principal Investigator Affiliation	Cairo University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Asbestosis

Additional Details

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.

Arms & Interventions