MedTrace Logo

Pirfenidone in the Chronic Hypersensitivity Pneumonitis Treatment

NCT02496182 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-07-14

No results posted yet for this study

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

Interventions

DRUG

Placebo

Placebo tablet only with the excipients of the Pirfenidone tablet

DRUG

Pirfenidone

Conventional Treatment (Prednisone+Azathioprine) plus Pirfenidone 1800 mg

DRUG

Pirfenidone

Conventional Treatment (Prednisone+Azathioprine) plus Pirfenidone 1200 mg

Sponsors & Collaborators

  • Grupo Medifarma, S. A. de C. V.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2016-01-31
Completion
2017-01-31

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02496182 on ClinicalTrials.gov