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Pirfenidone in the Chronic Hypersensitivity Pneumonitis Treatment (Picheon)

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ClinicalTrials.gov Identifier: NCT02496182
Recruitment Status : Unknown
Verified July 2015 by Grupo Medifarma, S. A. de C. V..
Recruitment status was:  Recruiting
First Posted : July 14, 2015
Last Update Posted : July 14, 2015
Sponsor:
Information provided by (Responsible Party):
Grupo Medifarma, S. A. de C. V.

Study Description
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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.


Condition or disease Intervention/treatment Phase
Alveolitis Extrinsic Allergic Pulmonary Fibrosis Drug: Placebo Drug: Pirfenidone Phase 2 Phase 3

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 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pirfenidone in the Chronic Hypersensitivity Pneumonitis Treatment
Study Start Date : July 2015
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Pneumonia
Drug Information available for: Pirfenidone

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
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
Placebo tablet only with the excipients of the Pirfenidone tablet
Other Name: Excipient Tablet
Experimental: Pirfenidone 1800 mg
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
Conventional Treatment (Prednisone+Azathioprine) plus Pirfenidone 1800 mg
Other Name: Kitoscell LP
Experimental: Pirfenidone 1200 mg
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
Conventional Treatment (Prednisone+Azathioprine) plus Pirfenidone 1200 mg
Other Name: KitosCell LP


Outcome Measures
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Primary Outcome Measures :
  1. Forced Vital Capacity (FVC) [ Time Frame: 52 weeks ]
    The measurement of FVC will be at 26 and 52 weeks


Secondary Outcome Measures :
  1. High Resolution Tomography [ Time Frame: 52 weeks ]
    Evaluation of the inflammation and fibrosis grade with the Kazerooni scale

  2. 6 minutes walk distance test [ Time Frame: 52 weeks ]
    quantification of the walking distance at 6 minutes

  3. San George Qty Score, SOBQ and EQ5D Quality Scores [ Time Frame: 52 weeks ]
    As a composite outcome to evaluate the quality of life

  4. Pulmonary artery systolic pressure with echocardiogram [ Time Frame: 52 weeks ]
    measurement of pressure

  5. Oxygen desaturation in exercise [ Time Frame: 52 weeks ]
    Measurement of Oxygen


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02496182


Contacts
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Contact: Pedro Pena, MD +52191971972 pedropena@grupomedifarma.com
Contact: Jarod Escobar, MD +525515764477 jarodescobar@cellpharma.com

Locations
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Mexico
Instituto Nacional de Enfermedades Respiratorias Recruiting
Mexico city, Distrito Federal, Mexico, 14080
Contact: Heidegger Mateos, MD    +5255 5487 1771      
Contact: Pedro Pena, MD    +5215591971972    pedropena@grupomedifarma.com   
Principal Investigator: Moises Selman Lama, PhD         
Sub-Investigator: Mayra Mejia, MD         
Sub-Investigator: Heidegger Mateo, MD         
Sub-Investigator: Ivette Buendia, MD         
Sponsors and Collaborators
Grupo Medifarma, S. A. de C. V.
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Grupo Medifarma, S. A. de C. V.
ClinicalTrials.gov Identifier: NCT02496182    
Other Study ID Numbers: C34-11
First Posted: July 14, 2015    Key Record Dates
Last Update Posted: July 14, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Pneumonia
Pulmonary Fibrosis
Alveolitis, Extrinsic Allergic
Hypersensitivity
Lung Diseases
Respiratory Tract Diseases
Immune System Diseases
Respiratory Tract Infections
Infections
Lung Diseases, Interstitial
Respiratory Hypersensitivity
 Hypersensitivity, Immediate
Pirfenidone
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents