A Pilot Study of Aerosol Interferon-Gamma for Treatment of Idiopathic Pulmonary Fibrosis
Information source: New York University School of Medicine
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pulmonary Fibrosis
Intervention: aerosol interferon-gamma (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: New York University School of Medicine Official(s) and/or principal investigator(s):
Rany Condos, MD, Principal Investigator, Affiliation: NYU School of Medicine
Overall contact:
Rany Condos, MD, Phone: 212 263 7951, Email: Rany.Condos@nyumc.org
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.
Clinical Details
Official title: A Pilot Study of Aerosol Interferon-Gamma for Treatment of Idiopathic Pulmonary Fibrosis
Study design: Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: safety, tolerability
Secondary outcome: lung deposition of aerosolized IFN, bronchoalveolar lavage fluid levels of IFN and fibrotic cytokines pre-and post-treatment, pulmonary function testing trends during treatment, descriptive data regarding symptoms and clinical findings
Detailed description:
Patients with mild-to-moderate idiopathic pulmonary fibrosis (IPF) will be enrolled in a
phase I study of aerosol interferon-gamma (IFN-γ). Prior to initiation of treatment,
patients will undergo CT of the chest, pulmonary function testing, and bronchoscopy with
bronchoalveolar lavage. They will also undergo a lung deposition study to determine the
lung dose of IFN-γ that will be delivered with each treatment. Patients will then receive
aerosol IFN-γ 100mcg delivered three times weekly via nebulizer for one year. Study
patients will be followed monthly to monitor potential side effects, vital signs, and
progression of IPF symptoms. Labs will be drawn at regular intervals to monitor for side
effects and to measure cytokine levels. Bronchoscopy will be performed at the 6 and/or 12
month visit to compare cytokine levels pre-, during, and post-treatment.
Eligibility
Minimum age: 40 Years.
Maximum age: 75 Years.
Gender(s): Both.
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.
Locations and Contacts
Rany Condos, MD, Phone: 212 263 7951, Email: Rany.Condos@nyumc.org
Division of Pulmonary & Critical Care Medicine, NYU School of Medicine, New York, New York 10016, United States; Recruiting
Rany Condos, MD, Principal Investigator
Sheryl R Goldyn, MD, MPH, Sub-Investigator
Additional Information
Starting date: January 2007
Last updated: November 21, 2007
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