A Safety and Efficacy trial of aerosol Interferon-gamma treatment in Pulmonary Fibrosis
Inclusion Criteria:
- Patients diagnosed with IPF based on accepted criteria within 30 months prior to
screening
- Age 20-70
- A failed trial of prednisone with or without cyclophosphamide/ azathioprine
- Patient taking 0-15mg prednisone or the equivalent for 28 days prior to study
enrollment and willing to remain on that same dose of corticosteroid
- FVC >= 50% and <= 90% of predicted baseline value at screening
- PaO2 > 60 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:
- Patient fits criteria for research bronchoscopy and is willing to undergo procedure
- Patient able to have medication administered three times per week at the GCRC unit at
Bellevue Hospital
Exclusion Criteria:
- No adequate treatment trial with prednisone, cyclophosphamide, or azathioprine
- patient unwilling or unable to undergo research bronchoscopy
- Patient with known asthma or severe COPD
- Patient requiring oxygen therapy for maintenance of adequate arterial oxygenation
- 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 age 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:
1. 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.
2. CBC outside specified limits: WBC < 2,500/mm3, hematocrit <30 or >59, platelets <
100,000/mm3.
3. Creatinine > 1. 5X upper limits normal at screening
- Drugs for therapy for pulmonary fibrosis, excluding
corticosteroids/cyclophosphamide/azathioprine, within the previous six months
- Prior therapy with any class of interferon medication
- Investigational therapy for any indication within the last 28 days
