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| Sponsor: | New York University School of Medicine |
|---|---|
| Collaborators: |
National Center for Research Resources (NCRR) Stony Brook University Philips Respironics |
| Information provided by: | New York University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00563212 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Fibrosis |
Drug: aerosol interferon-gamma |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pilot Study of Aerosol Interferon-gamma for Treatment of Idiopathic Pulmonary Fibrosis |
| Estimated Enrollment: | 12 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A1 |
Drug: aerosol interferon-gamma
aerosol interferon-gamma-1b 100mcg given via nebulizer three times weekly for one year
|
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| Ages Eligible for Study: | 40 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, New York | |
| Division of Pulmonary & Critical Care Medicine, NYU School of Medicine | |
| New York, New York, United States, 10016 | |
| Principal Investigator: | Rany Condos, MD | NYU School of Medicine |
More Information
| Responsible Party: | Gerald Smaldone, State University of New York at Stony Brook University |
| ClinicalTrials.gov Identifier: | NCT00563212 History of Changes |
| Other Study ID Numbers: | 9583, IFB 9583 |
| Study First Received: | November 21, 2007 |
| Last Updated: | January 3, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Lung Diseases, Interstitial Fibrosis Interferons Pulmonary Fibrosis Pathologic Processes |
Lung Diseases Fibrosing alveolitis Interferon-gamma, Recombinant Aerosols |
|
Fibrosis Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Pathologic Processes Lung Diseases Respiratory Tract Diseases Idiopathic Interstitial Pneumonias Lung Diseases, Interstitial |
Interferon-gamma Interferon-gamma, Recombinant Interferons Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents |