A Pilot Study of Aerosol Interferon-gamma for Treatment of Idiopathic Pulmonary Fibrosis
Completed · Phase 1
Conditions studied: Pulmonary Fibrosis
In brief
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.
Key facts
- Study ID
- NCT00563212
- Run by
- NYU Langone Health
- People needed
- 12
- Starts
- 2007-01-01
- Expected to finish
- 2018-12-01
- Last updated by the study team
- 2020-04-28
Who can join
Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Division of Pulmonary & Critical Care Medicine, NYU School of Medicine — New York, New York, United States
Full record on ClinicalTrials.gov
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