Pulmonary Fibrosis Clinical Trial
Official title:
Pirfenidone in the Chronic Hypersensitivity Pneumonitis Treatment
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.
The Chronic Hypersensitivity Pneumonitis (HP), is a complex syndrome due to a exaggerated
immune response caused by inhalation of foreign substances, such as molds, dusts, and
organic particles, causing alveoli inflammation and in the chronic forms the disease has
high rate of mortality, due to the big number of patients who develop progressive
interstitial fibrosis and eventually they curse with respiratory insufficiency who cause the
death of the patient.
Pirfenidone has been studied over the world for the treatment of Idiophatic Pulmonary
Fibrosis (IPF), disease who constitute the most aggressive of the fibrotic diseases of the
lung. Additionally Pirfenidone has been showed potential results in the treatment of
fibrotic diseases in other organs, as Liver, Kidney, Hearth, etc. Pirfenidone has been
described as a modulator of the fibrotic process due to his action over TGF-beta and MMP´s
and also has into-inflammatory actions acting over TNF-alfa and IL-1 and IL-6.
Actually HP has been treated with Prednisone and occasionally with Azathioprine, but a high
number of patients will develop irreversibly to a interstitial fibrosis with pulmonary
parenchyma destruction. Unfortunately the investigators have not an effective treatment for
this cases. Due to the positive results obtained with Pirfenidone in the treatment of IPF
and other kind of organ fibrosis, the investigators propose to evaluate the addition of
Pirfenidone to the treatment with Prednisone and Azathioprine in the treatment of patients
with Pulmonary Fibrosis secondary to a Chronic Hypersensitivity Pneumonitis.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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