Clinical trial NCT05133453: Pirfenidone Use in Asbestosis Patients: Efficacy and Prognosis
Official title: Pirfenidone Use in Asbestosis Patients: Efficacy and Prognosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Asbestosis
Keywords: Pirfenidone
Asbestosis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-11-24
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Ventilatory function change
timeFrame: after 6 months and 12 months from the start of the trial
measure: Diffusion test
timeFrame: after 6 months and 12 months from the start of the trial
measure: radiological findings change
timeFrame: after 6 months and 12 months from the start of the trial
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Marwa M Fouad, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.