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

Primary Purpose

Pulmonary Fibrosis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

aerosol interferon-gamma

About this trial

This is an interventional treatment trial for Pulmonary Fibrosis focused on measuring Lung Diseases, Interstitial, Fibrosis, Interferons, Pulmonary Fibrosis, Pathologic Processes, Lung Diseases, Fibrosing alveolitis, Interferon-gamma, Recombinant, Aerosols

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Division of Pulmonary & Critical Care Medicine, NYU School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

safety, tolerability

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00563212

First Posted

November 21, 2007

Last Updated

April 27, 2020

Sponsor

NYU Langone Health

Collaborators

National Center for Research Resources (NCRR), Stony Brook University, Philips Respironics

1. Study Identification

Unique Protocol Identification Number

NCT00563212

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

June 1, 2010 (Actual)

Study Completion Date

December 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NYU Langone Health

Collaborators

National Center for Research Resources (NCRR), Stony Brook University, Philips Respironics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Fibrosis

Keywords

Lung Diseases, Interstitial, Fibrosis, Interferons, Pulmonary Fibrosis, Pathologic Processes, Lung Diseases, Fibrosing alveolitis, Interferon-gamma, Recombinant, Aerosols

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

aerosol interferon-gamma

Intervention Description

aerosol interferon-gamma-1b 100mcg given via nebulizer three times weekly for one year

Primary Outcome Measure Information:

Title

safety, tolerability

Time Frame

one year

Secondary Outcome Measure Information:

Title

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rany Condos, MD

Organizational Affiliation

NYU School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Division of Pulmonary & Critical Care Medicine, NYU School of Medicine

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

12. IPD Sharing Statement

Citations:

Citation

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.

Results Reference

background

PubMed Identifier

35667792

Citation

Xue Y, Reddy SK, Garza LA. Toward Understanding Wound Immunology for High-Fidelity Skin Regeneration. Cold Spring Harb Perspect Biol. 2022 Jul 1;14(7):a041241. doi: 10.1101/cshperspect.a041241.

Results Reference

derived

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

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