Pirfenidone Use in Asbestosis Patients: Efficacy and Prognosis (NCT05133453) | Clinical Trial Compass
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Pirfenidone Use in Asbestosis Patients: Efficacy and Prognosis
40 participantsStarted 2024-02
Plain-language summary
This study aims at determining the the efficiency and prognosis of using pirfenidone drug among asbestosis patients.
Who can participate
Age range18 Years – 60 Years
SexMALE
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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.
What they're measuring
1
Ventilatory function change
Timeframe: after 6 months and 12 months from the start of the trial
2
Diffusion test
Timeframe: after 6 months and 12 months from the start of the trial
3
radiological findings change
Timeframe: after 6 months and 12 months from the start of the trial