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A Pilot Study of Aerosol Interferon-gamma for Treatment of Idiopathic Pulmonary Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00563212
Recruitment Status : Completed
First Posted : November 26, 2007
Last Update Posted : April 28, 2020
Sponsor:
Collaborators:
National Center for Research Resources (NCRR)
Stony Brook University
Philips Respironics
Information provided by (Responsible Party):
NYU Langone Health

Brief 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.

Condition or disease Intervention/treatment Phase
Pulmonary Fibrosis Drug: aerosol interferon-gamma Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Aerosol Interferon-gamma for Treatment of Idiopathic Pulmonary Fibrosis
Study Start Date : January 2007
Actual Primary Completion Date : June 1, 2010
Actual Study Completion Date : December 1, 2018


Arm Intervention/treatment
Experimental: A1 Drug: aerosol interferon-gamma
aerosol interferon-gamma-1b 100mcg given via nebulizer three times weekly for one year




Primary Outcome Measures :
  1. safety, tolerability [ Time Frame: one year ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00563212


Locations
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United States, New York
Division of Pulmonary & Critical Care Medicine, NYU School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
National Center for Research Resources (NCRR)
Stony Brook University
Philips Respironics
Investigators
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Principal Investigator: Rany Condos, MD NYU School of Medicine
Publications:
Goldyn SR, Smaldone GC, Rom WN, Condos R. Safety Profile of Aerosol Interferon-gamma. Abstract submitted to American Thoracic Society for presentation at ATS annual meeting May 2008, Toronto.

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT00563212    
Obsolete Identifiers: NCT00212563
Other Study ID Numbers: 9583
IFB 9583
First Posted: November 26, 2007    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NYU Langone Health:
Lung Diseases, Interstitial
Fibrosis
Interferons
Pulmonary Fibrosis
Pathologic Processes
Lung Diseases
Fibrosing alveolitis
Interferon-gamma, Recombinant
Aerosols
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Interferons
Interferon-gamma
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents