NCT01777737

Study to Test the Validity of the Treatment of Idiopathic Pulmonary Fibrosis With Cotrimoxazole

Pilot Study Phase III to Evaluate the Efficacy and Safety of Trimethoprim-sulfamethoxazole in the Treatment of Idiopathic Pulmonary Fibrosis

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

First study to test the validity of the treatment of idiopathic pulmonary fibrosis, which causes inflammation and fibrosis (scarring) of the lung tissue, with cotrimoxazole. Cotrimoxazole may improve the clinical course of the disease through eradication of Pneumocystis jiroveci colonization and other mechanisms as inhibiting the activation of alveolar macrophages and producing alterations in the surfactant system which favours the persistent activation of the inflammatory response and the development of pulmonary fibrosis.

Detailed description

Idiopathic pulmonary fibrosis (IPF) is a chronic lung disease that is clinically manifested by the appearance of effort dyspnea and impaired lung function. The natural history of the disease is poorly understood and there is no clear consensus as to the most appropriate markers for predicting patient outcome. This pilot controlled trial aims to test the efficacy and safety of cotrimoxazole in the treatment of IPF. This novel therapeutic strategy, with very encouraging preliminary data is based on its pathophysiological basis, primarily related to the elimination of Pneumocystis colonization. That elimination, could serve as a potent weapon for reducing morbidity and mortality and the cost associated with this devastating disease.

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	Cotrimoxazole	24 weeks of treatment
DRUG	Placebo	Identical capsules to cotrimoxazole

Timeline

• Start date: 2013-11-25
• Primary completion: 2015-11-05
• Completion: 2015-11-05
• First posted: 2013-01-29
• Last updated: 2017-11-14

Locations

1 site across 1 country: Spain