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

NCT ID: NCT00563212

Last Updated: 2020-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2018-12-01

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.

Conditions

Pulmonary Fibrosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A1

Group Type: EXPERIMENTAL

aerosol interferon-gamma

Intervention Type: DRUG

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

Interventions

aerosol interferon-gamma

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Research Resources (NCRR)

NIH

Sponsor Role: collaborator

Stony Brook University

OTHER

Sponsor Role: collaborator

Philips Respironics

INDUSTRY

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rany Condos, MD

Role: PRINCIPAL_INVESTIGATOR

NYU School of Medicine

Locations

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

New York, New York, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

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.

Reference Type: DERIVED

PMID: 35667792 (View on PubMed)

Other Identifiers

IFB 9583

Identifier Type: -

Identifier Source: secondary_id

9583

Identifier Type: -

Identifier Source: org_study_id

NCT00212563

Identifier Type: -

Identifier Source: nct_alias