drugset / Trial / NCT02496182

Pirfenidone in the Chronic Hypersensitivity Pneumonitis Treatment

NCT02496182

Phase 2/3 Unknown 60 enrolled Grupo Medifarma, S. A. de C. V.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The Chronic Hypersensitivity Pneumonitis (HP), is an inflammatory disease who has an evolution to develop progressive interstitial fibrosis, who cause the death of the patient. Actually HP has been treated with Prednisone and occasionally with Azathioprine, but unfortunately the treatment with these drugs have not an effective result to treat the interstitial fibrosis. Pirfenidone has been studied over the world for the treatment of Fibrotic diseases, with positive results, and due to the Pirfenidone mechanism of action has anti-inflammatory and anti-fibrotic properties, the investigators propose to evaluate the addition of Pirfenidone to the actual treatment with Prednisone and Azathioprine in the treatment of patients with Pulmonary Fibrosis secondary to a Chronic Hypersensitivity Pneumonitis.

Timeline

Start
2015-07
Primary completion
2016-01
Completion
2017-01

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Pirfenidone Small molecule 600 mg
Subject Pirfenidone Small molecule 900 mg