Pirfenidone in the Chronic Hypersensitivity Pneumonitis Treatment

• Status: Unknown status
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Grupo Medifarma, S. A. de C. V.
• Treatments: Azathioprine; Pirfenidone; Prednisone

Criteria

Inclusion Criteria:

• Chronic Hypersensitivity pneumonitis with recent diagnosis confirmed by HRT with or without biopsy

• Acceptation with signed informed consent

Exclusion Criteria:

• No confirmed diagnosis

• Patients with peptic ulcer

• Pregnancy or breast feeding period

• Clinical signs of active infection

• History of severe Hepatic disease

• History of severe Kidney disease, who requires some kind of dialysis

• History of inestable cardiopathy

• History of alcohol or drugs abuse

• Bronchial hyperactivity or History of asthma or EPOC

• Smoking habit 3 months before the starting or patient who decline suspend the smoking habit during the study

• Patient with impossibility to make spirometry or who can not walk

• Use of Immunosuppressants, cytotoxic agents, cytosine modulators or receptor antagonist, fluvoxamine or daily use of sildenafil.

• Patients who not accept sign the informed consent