NCT00563212

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

Completed Phase 1 Last updated 27 April 2020

What this trial tests

Phase 1 trial testing aerosol interferon-gamma in Pulmonary Fibrosis in 12 participants. Completed in 1 December 2018.

Timeline

1 January 2007

Primary endpoint
1 June 2010

1 December 2018

Quick facts

Lead sponsor	NYU Langone Health
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	1 January 2007
Primary completion	1 June 2010
Estimated completion	1 December 2018
Sites	1 location across United States

Drugs / interventions tested

• aerosol interferon-gamma — full drug profile →

Conditions studied

• Pulmonary Fibrosis — all drugs for Pulmonary Fibrosis →

Sponsor

NYU Langone Health — full company profile →

Who can join

Adults 40 to 75, any sex, with Pulmonary Fibrosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• safety, tolerability
  Time frame: one year

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting fibrosis, mechanisms and cilinical trials.
   Zhao M, Wang L, Wang M, Zhou S, et al · · 2022 · cited 352× · PMID 35773269 · DOI 10.1038/s41392-022-01070-3
2. A review of current and novel therapies for idiopathic pulmonary fibrosis.
   Rafii R, Juarez MM, Albertson TE, Chan AL. · · 2013 · cited 102× · PMID 23372951 · DOI 10.3978/j.issn.2072-1439.2012.12.07
3. Pharmacotherapy and adjunctive treatment for idiopathic pulmonary fibrosis (IPF).
   Saito S, Alkhatib A, Kolls JK, Kondoh Y, et al · · 2019 · cited 98× · PMID 31632751 · DOI 10.21037/jtd.2019.04.62
4. Lung microbiome and host immune tone in subjects with idiopathic pulmonary fibrosis treated with inhaled interferon-γ.
   Wang J, Lesko M, Badri MH, Kapoor BC, et al · · 2017 · cited 25× · PMID 28717640 · DOI 10.1183/23120541.00008-2017
5. The Immune Microenvironment: New Therapeutic Implications in Organ Fibrosis.
   Chen X, Wu C, Tang F, Zhou J, et al · · 2025 · cited 3× · PMID 40391706 · DOI 10.1002/advs.202505067
6. Toward Understanding Wound Immunology for High-Fidelity Skin Regeneration.
   Xue Y, Reddy SK, Garza LA. · · 2022 · cited 2× · PMID 35667792 · DOI 10.1101/cshperspect.a041241
7. Unlocking the potential of mRNA nanomedicines for comprehensive fibrosis therapy.
   Yang Y, Li C, Xiong W, Li C, et al · · 2026 · PMID 42003885 · DOI 10.1016/j.omtn.2026.102917