Pirfenidone in the Chronic Hypersensitivity Pneumonitis Treatment (Picheon)

July 13, 2015 updated by: Grupo Medifarma, S. A. de C. V.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
    • Distrito Federal
      • Mexico city, Distrito Federal, Mexico, 14080
        • Recruiting
        • Instituto Nacional de Enfermedades Respiratorias
        • Sub-Investigator:
          • Mayra Mejia, MD
        • Contact:
          • Heidegger Mateos, MD
          • Phone Number: +5255 5487 1771
        • Contact:
        • Principal Investigator:
          • Moises Selman Lama, PhD
        • Sub-Investigator:
          • Heidegger Mateo, MD
        • Sub-Investigator:
          • Ivette Buendia, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Kitoscell LP
Drug: Pirfenidone
Conventional Treatment (Prednisone+Azathioprine) plus Pirfenidone 1200 mg
Other Names:
  • 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 1800 mg
Other Names:
  • Kitoscell LP
Drug: Pirfenidone
Conventional Treatment (Prednisone+Azathioprine) plus Pirfenidone 1200 mg
Other Names:
  • KitosCell LP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forced Vital Capacity (FVC)
Time Frame: 52 weeks
The measurement of FVC will be at 26 and 52 weeks
52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
High Resolution Tomography
Time Frame: 52 weeks
Evaluation of the inflammation and fibrosis grade with the Kazerooni scale
52 weeks
6 minutes walk distance test
Time Frame: 52 weeks
quantification of the walking distance at 6 minutes
52 weeks
San George Qty Score, SOBQ and EQ5D Quality Scores
Time Frame: 52 weeks
As a composite outcome to evaluate the quality of life
52 weeks
Pulmonary artery systolic pressure with echocardiogram
Time Frame: 52 weeks
measurement of pressure
52 weeks
Oxygen desaturation in exercise
Time Frame: 52 weeks
Measurement of Oxygen
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo Medifarma, S. A. de C. V.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

July 6, 2015

First Submitted That Met QC Criteria

July 13, 2015

First Posted (Estimate)

July 14, 2015

Study Record Updates

Last Update Posted (Estimate)

July 14, 2015

Last Update Submitted That Met QC Criteria

July 13, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C34-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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