Pirfenidone in the Chronic Hypersensitivity Pneumonitis Treatment

Pulmonary Fibrosis Clinical Trial

— Picheon  

Official title:

Pirfenidone in the Chronic Hypersensitivity Pneumonitis Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02496182
• Other study ID #: C34-11
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: July 6, 2015
• Last updated: July 13, 2015
• Start date: July 2015
• Est. completion date: January 2017

Study information

• Verified date: July 2015
• Source: Grupo Medifarma, S. A. de C. V.
• Contact: Pedro Pena, MD
• Phone: +52191971972
• Email: pedropena[@]grupomedifarma.com
• Is FDA regulated: No
• Health authority: Mexico: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2017
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alveolitis Extrinsic Allergic
• Alveolitis, Extrinsic Allergic
• Hypersensitivity
• Pulmonary Fibrosis

Intervention

Drug:
• Placebo
Placebo tablet only with the excipients of the Pirfenidone tablet
• Pirfenidone
Conventional Treatment (Prednisone+Azathioprine) plus Pirfenidone 1800 mg
• Pirfenidone
Conventional Treatment (Prednisone+Azathioprine) plus Pirfenidone 1200 mg

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Enfermedades Respiratorias	Mexico city	Distrito Federal

Sponsors (1)

Lead Sponsor	Collaborator
Grupo Medifarma, S. A. de C. V.

Country where clinical trial is conducted

Mexico, 

References & Publications (6)

Gaxiola M, Buendía-Roldán I, Mejía M, Carrillo G, Estrada A, Navarro MC, Rojas-Serrano J, Selman M. Morphologic diversity of chronic pigeon breeder's disease: clinical features and survival. Respir Med. 2011 Apr;105(4):608-14. doi: 10.1016/j.rmed.2010.11.026. Epub 2010 Dec 16. — View Citation

Lacasse Y, Selman M, Costabel U, Dalphin JC, Ando M, Morell F, Erkinjuntti-Pekkanen R, Muller N, Colby TV, Schuyler M, Cormier Y; HP Study Group. Clinical diagnosis of hypersensitivity pneumonitis. Am J Respir Crit Care Med. 2003 Oct 15;168(8):952-8. Epub 2003 Jul 3. — View Citation

Macías-Barragán J, Sandoval-Rodríguez A, Navarro-Partida J, Armendáriz-Borunda J. The multifaceted role of pirfenidone and its novel targets. Fibrogenesis Tissue Repair. 2010 Sep 1;3:16. doi: 10.1186/1755-1536-3-16. — View Citation

Schaefer CJ, Ruhrmund DW, Pan L, Seiwert SD, Kossen K. Antifibrotic activities of pirfenidone in animal models. Eur Respir Rev. 2011 Jun;20(120):85-97. doi: 10.1183/09059180.00001111. Review. — View Citation

Selman M, Pardo A, Richeldi L, Cerri S. Emerging drugs for idiopathic pulmonary fibrosis. Expert Opin Emerg Drugs. 2011 Jun;16(2):341-62. doi: 10.1517/14728214.2011.565049. Epub 2011 Mar 17. Review. — View Citation

Selman M. Hypersensitivity pneumonitis: a multifaceted deceiving disorder. Clin Chest Med. 2004 Sep;25(3):531-47, vi. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced Vital Capacity (FVC)	The measurement of FVC will be at 26 and 52 weeks	52 weeks	Yes
Secondary	High Resolution Tomography	Evaluation of the inflammation and fibrosis grade with the Kazerooni scale	52 weeks	Yes
Secondary	6 minutes walk distance test	quantification of the walking distance at 6 minutes	52 weeks	Yes
Secondary	San George Qty Score, SOBQ and EQ5D Quality Scores	As a composite outcome to evaluate the quality of life	52 weeks	Yes
Secondary	Pulmonary artery systolic pressure with echocardiogram	measurement of pressure	52 weeks	Yes
Secondary	Oxygen desaturation in exercise	Measurement of Oxygen	52 weeks	Yes