TerminatedPhase 2

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

Stopped: covid-19 pandemic

United States40 participantsStarted 2017-06-05

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Multidisciplinary consensus diagnosis of FHP, defined from the first instance in which a patient was informed of having FHP for at least 3 to 6 months.
✓. Age 18 through 80 years at randomization.
✓. Diagnosis of typical or compatible FHP by HRCT according to pre-specified criteria (Note: HRCT scan performed within 6 months of the start of screening may be used if it meets image acquisition guidelines):
✓. FVC ≥40%, DLCO ≥30% based either on historical pulmonary function tests obtained in the 30 days prior to screening or on tests obtained during screening
✓. In the investigator's opinion, evidence of disease progression: worsening respiratory symptoms and an increased in the extent of fibrosis on HRCT or relative decline in the FVC% of at least 5%.
✓. Able to walk ≥100 m during the 6-minute walk test (6MWT) at Screening.
✓. Able to understand and sign a written informed consent form.
✓. Able to understand the importance of adherence to study treatment and the study protocol and willing to follow all study requirements, including the concomitant medication restrictions, throughout the study

Exclusion criteria

What they're measuring

Mean Change From Baseline to Week 52 in Percent Predicted FVC.

Timeframe: Up to 52 weeks.

Trial details

NCT IDNCT02958917

SponsorEvans Fernandez Perez

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-03-02

Results submitted2022-09-27

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