Ignite Creation Date:
2024-05-06 @ 7:12 AM
Last Modification Date:
2024-10-26 @ 11:46 AM
Study NCT ID:
NCT02496182
Status:
UNKNOWN
Last Update Posted:
2015-07-14
First Post:
2015-07-06
Brief Title:
Pirfenidone in the Chronic Hypersensitivity Pneumonitis Treatment
Sponsor:
Grupo Medifarma S A de C V
Organization:
Grupo Medifarma S A de C V
Study Overview
Official Title:
Pirfenidone in the Chronic Hypersensitivity Pneumonitis Treatment
Status:
UNKNOWN
Status Verified Date:
2015-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Picheon
Brief 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
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
Detailed Description:
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 MMPs 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
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 MMPs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None