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

NCT00563212 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: 9583IFB 9583
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Fibrosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• safety, tolerability

  one year

Secondary Outcomes (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

  one year

Study Arms (1)

A1

EXPERIMENTAL

Drug: aerosol interferon-gamma

Interventions

aerosol interferon-gamma DRUG

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

A1

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead
• National Center for Research Resources (NCRR): collaborator
• Stony Brook University: collaborator
• Philips Respironics: collaborator

Study Sites (1)

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

New York, New York, 10016, United States

Location

Related Publications (2)

• 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.

  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.

  PMID: 35667792 DERIVED

MeSH Terms

Conditions

Pulmonary Fibrosis; Lung Diseases, Interstitial; Fibrosis; Pathologic Processes; Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Pathological Conditions, Signs and Symptoms

Study Officials

• Rany Condos, MD

  NYU School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2007
• First Posted: November 26, 2007
• Study Start: January 1, 2007
• Primary Completion: June 1, 2010
• Study Completion: December 1, 2018
• Last Updated: April 28, 2020

Record last verified: 2020-04

Locations

US (1)