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| Sponsor: | New York University School of Medicine |
|---|---|
| Collaborators: |
National Center for Research Resources (NCRR) Stony Brook University 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: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| 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: | January 2009 |
| Arms | Assigned Interventions |
|---|---|
| A1: Experimental |
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| Contact: Rany Condos, MD | 212 263 7951 | Rany.Condos@nyumc.org |
| Contact: Sheryl R Goldyn, MD, MPH | 212 263 6479 | goldys01@med.nyu.edu |
| United States, New York | |
| Division of Pulmonary & Critical Care Medicine, NYU School of Medicine | Recruiting |
| New York, New York, United States, 10016 | |
| Principal Investigator: Rany Condos, MD | |
| Sub-Investigator: Sheryl R Goldyn, MD, MPH | |
| Principal Investigator: | Rany Condos, MD | NYU School of Medicine |
More Information
| Study ID Numbers: | 9583, IFB 9583 |
| Study First Received: | November 21, 2007 |
| Last Updated: | November 21, 2007 |
| ClinicalTrials.gov Identifier: | NCT00563212 History of Changes |
| 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 |
|
Anti-Infective Agents Lung Diseases, Interstitial Interferon Type II Antineoplastic Agents Fibrosis Interferons Pulmonary Fibrosis |
Antiviral Agents Pharmacologic Actions Pathologic Processes Respiratory Tract Diseases Lung Diseases Therapeutic Uses Interferon-gamma, Recombinant |