Pirfenidone in the Chronic Hypersensitivity Pneumonitis Treatment

NCT02496182 | Unknown Phase 2 DMC

• 1 other identifier: C34-11
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Alveolitis Extrinsic Allergic; Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• Forced Vital Capacity (FVC)

  The measurement of FVC will be at 26 and 52 weeks

  52 weeks

Secondary Outcomes (5)

• High Resolution Tomography

  52 weeks

• 6 minutes walk distance test

  52 weeks

• San George Qty Score, SOBQ and EQ5D Quality Scores

  52 weeks

• Pulmonary artery systolic pressure with echocardiogram

  52 weeks

• Oxygen desaturation in exercise

  52 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Conventional treatment (Prednisone 0.5 mg/kg/day for 4 weeks, then 0.25 mg/Kg/day for 8 weeks and maintenance dosage of 0.125 mg/Kg/day plus Azathioprine 2-3 mg/kg/day with a maximal dosage of 150 mg/day starting with 25-50 mg/day increasing gradually until day 14 with maximal dosage) plus Placebo tablet 2 times at day.

Drug: Placebo

Pirfenidone 1800 mg

EXPERIMENTAL

Conventional treatment (0.5 mg/kg/day for 4 weeks, then 0.25 mg/Kg/day for 8 weeks and maintenance dosage of 0.125 mg/Kg/day plus Azathioprine 2-3 mg/kg/day with a maximal dosage of 150 mg/day starting with 25-50 mg/day increasing gradually until day 14 with maximal dosage) plus Pirfenidone long release tablet 900 mg 2 times at day, starting with 600 mg at day

Drug: Pirfenidone

Pirfenidone 1200 mg

EXPERIMENTAL

Conventional treatment (0.5 mg/kg/day for 4 weeks, then 0.25 mg/Kg/day for 8 weeks and maintenance dosage of 0.125 mg/Kg/day plus Azathioprine 2-3 mg/kg/day with a maximal dosage of 150 mg/day starting with 25-50 mg/day increasing gradually until day 14 with maximal dosage) plus Pirfenidone long release tablet 600 mg 2 times at day starting with 600 mg at day

Drug: Pirfenidone

Interventions

Placebo DRUG

Placebo tablet only with the excipients of the Pirfenidone tablet

Also known as: Excipient Tablet

Placebo

Pirfenidone DRUG

Conventional Treatment (Prednisone+Azathioprine) plus Pirfenidone 1800 mg

Also known as: Kitoscell LP

Pirfenidone 1800 mg

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic Hypersensitivity pneumonitis with recent diagnosis confirmed by HRT with or without biopsy
• Acceptation with signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Grupo Medifarma, S. A. de C. V.: lead

Study Sites (1)

Instituto Nacional de Enfermedades Respiratorias

Mexico City, Mexico City, 14080, Mexico

RECRUITING

Related Publications (7)

• 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. doi: 10.1164/rccm.200301-137OC. Epub 2003 Jul 3.

  PMID: 12842854 BACKGROUND

• Selman M. Hypersensitivity pneumonitis: a multifaceted deceiving disorder. Clin Chest Med. 2004 Sep;25(3):531-47, vi. doi: 10.1016/j.ccm.2004.04.001.

  PMID: 15331190 BACKGROUND

• Gaxiola M, Buendia-Roldan I, Mejia 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.

  PMID: 21167698 BACKGROUND

• Macias-Barragan J, Sandoval-Rodriguez A, Navarro-Partida J, Armendariz-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.

  PMID: 20809935 BACKGROUND

• 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.

  PMID: 21410428 BACKGROUND

• 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.

  PMID: 21632796 BACKGROUND

• Mateos-Toledo H, Mejia-Avila M, Rodriguez-Barreto O, Mejia-Hurtado JG, Rojas-Serrano J, Estrada A, Castillo-Pedroza J, Castillo-Castillo K, Gaxiola M, Buendia-Roldan I, Selman M. An Open-label Study With Pirfenidone on Chronic Hypersensitivity Pneumonitis. Arch Bronconeumol (Engl Ed). 2020 Mar;56(3):163-169. doi: 10.1016/j.arbres.2019.08.019. Epub 2019 Nov 26. English, Spanish.

  PMID: 31784348 DERIVED

MeSH Terms

Conditions

Alveolitis, Extrinsic Allergic; Pulmonary Fibrosis

Interventions

Excipients; pirfenidone

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pharmaceutical Vehicles; Pharmaceutic Aids; Pharmaceutical Preparations; Specialty Uses of Chemicals; Chemical Actions and Uses

Central Study Contacts

Pedro Pena, MD

CONTACT

+52191971972; pedropena@grupomedifarma.com

Jarod Escobar, MD

CONTACT

+525515764477; jarodescobar@cellpharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2015
• First Posted: July 14, 2015
• Study Start: July 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2017
• Last Updated: July 14, 2015

Record last verified: 2015-07

Locations

ME (1)