A Pilot Study of Aerosol Interferon-gamma for Treatment of Idiopathic Pulmonary Fibrosis

• Status: Completed
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Idiopathic pulmonary fibrosis (IPF) is a progressive disease for which there is no effective treatment. Interferon-gamma is a medication that has been used for other lung diseases to decrease scarring and fibrosis. Studies of interferon-gamma injected under the skin did not show any improvement in survival in patients with IPF. We hypothesize that giving interferon-gamma as a nebulized mist directly into the lungs can affect the immune system in a way that decreases fibrosis.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Collaborators: National Center for Research Resources (NCRR); Philips Respironics; Stony Brook University
• Treatments: Interferon-gamma; Interferons

Criteria

Inclusion Criteria:

• Patients diagnosed with IPF based on accepted criteria (see above) within 12 months prior to screening.

• Age 40-75.

• Absence of significant pulmonary hypertension as measured by right heart catheterization (mPAP ≥ 30 mmHG) or echocardiography (RVSP ≥ 50 mmHg).

• FVC ≥ 55% of predicted baseline value at screening; DLCO ≥ 30% predicted.

• PaO2 ≥ 65 mm Hg at rest on room air

• Patient able to understand and willing to sign a written informed consent and willing to comply with all requirements of the study protocol including lung deposition studies.

• Patient fits criteria for research bronchoscopy and is willing to undergo procedure.

Exclusion Criteria:

• Six minute walk distance of < 200 meters.

• Patient unwilling or unable to undergo research bronchoscopy.

• Patient with known life threatening asthma or severe COPD.

• Patient requiring oxygen therapy for maintenance of adequate arterial oxygenation at rest.

• Patient with hypersensitivity to study medication or other component medication.

• Patient with known severe cardiac disease, severe peripheral vascular disease or seizure disorder which may be exacerbated by study drug administration (contraindications to drug administration as per package insert).

• Pregnant or lactating; Females of child-bearing potential will be required to have negative pregnancy test and be required to use accepted form of birth control (abstinence for study duration is the preferred method).

• Evidence of active infection within one week prior to treatment.

• Any condition, other than IPF, which is likely to result in the death of the patient within one year from study enrollment.

• Abnormal serum laboratory values including:

• Liver function above specified limits: total bilirubin > 1.5 X upper limits of normal, alanine amino transferase > 3X upper limit of normal, alkaline phosphatase > 3X upper limit of normal, albumin < 3.0 at screening.

• CBC outside specified limits: WBC < 2,500/mm3, hematocrit < 30 or > 59, platelets < 100,000/mm3.

• Creatinine > 1.5X upper limits normal at screening.

• Drugs for therapy for pulmonary fibrosis, including corticosteroids, azathioprine and/or cyclophosphamide, or n-acetylcysteine within the previous six weeks.

• Prior therapy with any class of interferon medication.

• Investigational therapy for any indication within the last 28 days.

• In a pulmonary rehabilitation program or planning to attend a pulmonary rehabilitation program.