NCT05118256

Pirfenidone for the Reduction of Metabolic, Inflammatory and Fibrogenic Activity in Complicated Silicosis

Status unknown Phase 2 Last updated 13 January 2022

What this trial tests

Phase 2 trial testing Pirfenidone Oral Tablet in Silicosis in 18 participants. Status unknown.

Timeline

15 November 2021

Primary endpoint
15 November 2022

15 November 2023

Quick facts

Lead sponsor	Instituto de investigación e innovación biomédica de Cádiz
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	18
Start date	15 November 2021
Primary completion	15 November 2022
Estimated completion	15 November 2023
Sites	1 location across Spain

Drugs / interventions tested

• Pirfenidone Oral Tablet

Conditions studied

• Silicosis — all drugs for Silicosis →
• Progressive Massive Fibrosis — all drugs for Progressive Massive Fibrosis →
• Complicated Silicosis — all drugs for Complicated Silicosis →

Sponsor

Instituto de investigación e innovación biomédica de Cádiz — full company profile →

Who can join

18 and older, male only, with Silicosis or Progressive Massive Fibrosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Silicosis is one of the leading causes of occupational respiratory disease worldwide. It is due to inhalation of respirable crystalline silica and can lead to progressive massive fibrosis (PMF), respiratory failure, and death. It is estimated that it causes more than 10,000 deaths a year worldwide, mainly in developing countries, although the level of underdiagnosis is high. In developed countries the incidence of the disease has been progressively decreasing in recent years, mainly due to the implementation of effective prevention measures, better occupational health surveillance systems and the displacement of mining activity to other countries, in a way that in the United Kingdom 216 cases were reported from 1996 to 2017. At the moment, there is no curative treatment for the disease, and the only therapeutic option is lung transplantation (when the disease evolves to PMF and subsequent respiratory failure). Meanwhile, the only accepted treatment is supportive treatment, with the administration of oxygen therapy in case of respiratory failure, early treatment of respiratory infections, vaccinations and respiratory rehabilitation. In recent years, molecules with antifibrogenic capacity have been developed and have demonstrated their ability to decrease pulmonary fibrogenic activity in diseases such as Idiopathic Pulmonary Fibrosis (IPF). This has been a milestone in the treatment of this disease and, therefore, its possible application to other diseases that share fibrogenic mechanisms with IPF, as PMF. The two molecules with the most clinical experience and approved for IPF are nintedanib and pirfenidone. The antifibrotic properties of pirfenidone have raised great expectations and many clinical trials are currently being carried out in other lung diseases that cause fibrosis, that is why we decide to study the efficacy of pirfenidone in reducing metabolic, inflammatory, and fibrogenic lung disease in patients with artificial stone silicosis and progressive massive fibrosis (PMF).

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Efficacy of Pirfenidone and Nintedanib in Interstitial Lung Diseases Other than Idiopathic Pulmonary Fibrosis: A Systematic Review.
   Amati F, Stainer A, Polelli V, Mantero M, et al · · 2023 · cited 45× · PMID 37175556 · DOI 10.3390/ijms24097849
2. Use of pirfenidone in fibrotic interstitial lung diseases and beyond: a review.
   Han M, Liu Q, Ji Z, Jin L, et al · · 2024 · cited 5× · PMID 39165369 · DOI 10.3389/fmed.2024.1411279
3. Autoimmune findings in patients with silicosis in Spain.
   González Fernández C, Ros Lucas JA, Molina Molina M, Rigual Bobillo J, et al · · 2024 · cited 1× · PMID 38440072 · DOI 10.7573/dic.2023-11-1
4. Advances in the identification and management of progressive pulmonary fibrosis: perspective from Chinese experts.
   Huang H, Wang Q, Xu Z. · · 2024 · PMID 39415340 · DOI 10.1177/17534666241288417