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

Pulmonary Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00563212
• Other study ID #: 9583
• Secondary ID: IFB 9583
• Status: Completed
• Phase: Phase 1
• Start date: January 2007
• Est. completion date: December 1, 2018

Study information

• Verified date: April 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00212563

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 1, 2018
• Est. primary completion date: June 1, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

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

Locations

Country	Name	City	State
United States	Division of Pulmonary & Critical Care Medicine, NYU School of Medicine	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
NYU Langone Health	National Center for Research Resources (NCRR), Philips Respironics, Stony Brook University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety, tolerability		one year
Secondary	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