Ongoing Phase III Clinical Trial to Test Idiopathic Pulmonary Fibrosis Treatment with Cotrimoxazole

A phase III clinical trial sponsored by the Fundación Pública Andaluza para la gestión de la Investigación en Sevilla (FISEVI) in Spain is currently recruiting participants to enroll in a study designed to assess the efficacy of idiopathic pulmonary fibrosis (IPF) treatment, cotrimoxazole (TriSulfa-FPI). The study is entitled “Pilot Study Phase III to Evaluate the Efficacy and Safety of Trimethoprim-sulfamethoxazole in the Treatment of Idiopathic Pulmonary Fibrosis” and the clinical trial is registered under the identifier NCT01777737.

IPF is a rare, fatal lung disease in which the lung tissues and the alveoli are damaged, turning thick and scarred, compromising the oxygen transfer between the lungs and the bloodstream. The generation of the scar tissue is known as fibrosis. IPF is characterized by shortness of breath (dyspnea) that gradually worsens, with respiratory failure being the main cause of death associated with IPF. There is no cure for this disease and the majority of the patients live three to five years after being diagnosed.

The primary goal of this clinical trial is to assess the efficacy of IPF treatment with oral cotrimoxazole in comparison with a placebo drug. Cotrimoxazole is in fact a combination antibiotic of trimethoprim (80 mg) and sulfamethoxazole (400 mg) that is used in the treatment of bacterial, fungal and protozoal infections. Researchers believe that this antibiotic can improve the clinical symptoms of IPF by mainly eradicating Pneumocystis jiroveci colonization (that causes Pneumocystis pneumonia), but also by blocking the activation of macrophages in the alveoli and by inducing alterations in the surfactant system to decrease chronic inflammatory response and pulmonary fibrosis development.

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The secondary outcomes of this trial are to evaluate the safety of IPF treatment with cotrimoxazole, the impact of the antibiotic in Pneumocystis colonization in IPF patients, and to determine the effect of the medication in the inflammatory response in these patients.

This trial is designed as an interventional, double-blind, randomized study and is expected to enroll 56 participants. Cotrimoxazole will be orally provided as capsules for 24 weeks and the same schedule will be applied for the placebo.

Individuals aged 18 to 80 years from both genders with well-established IPF diagnosis, forced vital capacity (FVC) above 50% from the theoretical value expected, and the ability to obtain a sample of sputum or oropharyngeal washing are eligible for this trial.

The FISEVI researchers are currently recruiting participants to enroll on this study. For more information, please contact Dr. Francisco Medrano Ortega at Hospital Universitario Virgen del Rocío/Instituto de Biomedicina de Sevilla via the e-mail [email protected].