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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Diagnosis of FHP, defined from the first instance in which a patient was informed of having FHP for at least 3 to 6 months. 2. Age 18 through 80 years at randomization. 3. Diagnosis of possible or definite FHP by HRCT according to pre-specified criteria (Note: HRCT scan performed within 6 month of the start of screening may be use if it meets image acquisition guidelines): i. Definite FHP: Evidence of lung fibrosis (reticular abnormality and/or, traction bronchiectasis and/or, architectural distortion, and/or honeycombing) and one or more of the associated finding: 1. Multilobular inspiratory mosaic attenuation 2. Multilobular air trapping on expiratory images 3. Profuse centrilobular ground glass nodular opacities ii. Possible FHP: Evidence of lung fibrosis (as above) in the absence of any of above associated findings. a. These patients are required to have a known exposure or BAL lymphocytosis or transbronchial biopsies demonstrating non-necrotizing granulomas. FHP Disease Severity and Progression 4. FVC ≥40%, DLCO ≥30% based either on historical pulmonary function tests obtained in the 30 days prior screening or on tests obtained during screening 5. In the investigator's opinion, no evidence of improvement in measures of FHP disease severity over the preceding year. 6. Able to walk ≥100 m during the 6-minute walk test (6MWT) at Screening. Informed Consent and Protocol Adherence 7. Able to understand and sign a written informed consent form. 8. 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:

  • - Disease-Related Exclusions 1.
Not a suitable candidate for enrollment or unlikely to comply with the requirements of this study, in the opinion of the investigator 2. Cigarette smoking at Screening or unwilling to avoid tobacco products throughout the study 3. Known explanation for the interstitial lung disease, including but not limited to radiation, drug toxicity, sarcoidosis, pneumoconiosis. 4. Clinical diagnosis of any connective tissue disease, including but not limited to scleroderma, polymyositis/dermatomyositis, and rheumatoid arthritis. 5. Expected to receive a lung transplant within 6 to12 months from randomization or on a lung transplant waiting list at randomization. Medical Exclusions 6. Any condition other than FHP that, in the opinion of the investigator, is likely to result in the death of the patient within 6 to12 months. 7. Any condition that, in the opinion of the investigator, might be significantly exacerbated by the known side effects associated with the administration of pirfenidone. 8. Pregnancy or lactation. Women of childbearing capacity are required to have a negative serum pregnancy test before treatment and must agree to maintain highly effective contraception by practicing abstinence or by using at least two methods of birth control from the date of consent through the end of the study. If abstinence is not practiced, one of the two methods of birth control should be an oral contraceptive (e.g., oral contraceptive and a spermicide). 9. History of ongoing alcohol or substance abuse. 10. History of severe hepatic impairment or end-stage liver disease. 11. History of end-stage renal disease requiring dialysis. 12. Clinical evidence of active infection including, but not limited to, bronchitis, pneumonia, sinusitis, or urinary tract infection. 13. Unstable or deteriorating cardiac disease, including but not limited to the following: 1. Unstable angina pectoris or myocardial infarction. 2. Congestive heart failure requiring hospitalization. 3. Uncontrolled clinically significant arrhythmias.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02958917
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

National Jewish Health
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Evans Fernandez, MD
Principal Investigator Affiliation National Jewish Health
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherIndustry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Interstitial Lung Disease
Additional Details

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).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

National Jewish Health, Denver, Colorado

Status

Recruiting

Address

National Jewish Health

Denver, Colorado, 80206

Site Contact

Kaitlin Fier

fierk@njhealth.org

303-270-2852

Terms of Service

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