Clinical Trial: Study of Efficacy and Safety of Pirfenidone in Patients With Fibrotic Hypersensitivity Pneumonitis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomized, Double-Blind, Placebo-Controlled, Study of Efficacy and Safety of Pirfenidone in Patients With Fibrotic Hypersensitivity Pneumonitis

Brief Summary:

Patients are being offered participation in this pirfenidone trial because They have been diagnosed with fibrotic hypersensitivity pneumonitis (FHP), a type of interstitial lung disease (ILD). This is a disease where scarring of lung tissue occurs as the result of inhaling substances called antigens. These antigens can be substances such as molds, chemicals or dust. As a result of this scarring the lungs are is not able to move oxygen into the bloodstream to reach other organs.

Currently over 1400 subjects have been treated with pirfenidone in 15 clinical trials. This drug has been approved by the Food and Drug Administration (FDA) for use in Idiopathic Pulmonary Fibrosis, a different type of ILD, but requires special permission for use in your condition. The use of pirfenidone has not been approved for the treatment of FHP. It is considered experimental treatment in this study.


Detailed Summary:

The purpose of this study is to evaluate the potential benefits and the safety of treatment with pirfenidone compared to placebo in subjects with FHP.

STUDY SUMMARY This study will include about 40 subjects at National Jewish Health. This is a "double blind study" which means neither the subject nor the study staff will know if the subject is get pirfenidone or placebo during the study. This is done to be sure that no one knows who is getting pirfenidone or placebo and the effects of the treatment can be measured objectively, without bias. Subject's that enroll in this study will have an equal chance of getting pirfenidone or placebo. The decision about which treatment the subject will receive (randomization) is made through a central organization.

Subjects in the study will receive either pirfenidone (2403 mg every day) or placebo capsules (a safe, inactive substance that will look the same as the pirfenidone capsules). Both the placebo and pirfenidone will be supplied in opaque, hard, white gelatin capsules and will be taken as 3 capsules by mouth, 3 times a day (a total of 9 capsules per day) and should be taken with food.

Subjects participate in this study, will be asked to take the capsules as prescribed every day for 52 weeks (12 months).


Sponsor: National Jewish Health

Current Primary Outcome: Mean change from baseline to week 52 in %FVC. [ Time Frame: Up to 52 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Progression-free survival (PFS) defined as the time from study treatment randomization to the first occurrence of any of the following events: [ Time Frame: Up to 52 weeks ]

  • ≥5% mean change from baseline to week 52 in %FVC.
  • Evidence of progression in fibrosis on visual comparison of baseline and week 52 HRCT scans.

  • Acute exacerbation of FHP defined as acute respiratory declined leading to hospitalization or ER or Urgent care evaluation; or evidence of all of the following criteria within a 4-week period in the outpatient setting:

    • Increase from baseline FIO2 ≥1 L O2.
    • Clinically significant worsening of dyspnea and/or cough.
    • New, superimposed ground-glass opacities or consolidation or new alveolar opacities on chest x-ray or CT.
  • Primary: if all other causes excluded (e.g., acute gastro-esophageal aspiration, pneumothorax, infection, left heart failure, pulmonary embolism, or identifiable cause of acute lung injury).
  • A decrease from baseline of at least 50 meters in 6-minute walk distance.


Original Secondary Outcome: Same as current

Information By: National Jewish Health

Dates:
Date Received: October 31, 2016
Date Started: March 4, 2017
Date Completion: December 2018
Last Updated: May 1, 2017
Last Verified: May 2017