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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by New York University School of Medicine.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Stony Brook University
Philips Respironics
Information provided by (Responsible Party):
Rany Condos, MD, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00563212
First received: November 21, 2007
Last updated: June 20, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Pulmonary Fibrosis
Drug: aerosol interferon-gamma
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Aerosol Interferon-gamma for Treatment of Idiopathic Pulmonary Fibrosis

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • safety, tolerability [ Time Frame: one year ] [ Designated as safety issue: Yes ]

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 [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: January 2007
Estimated Study Completion Date: June 2013
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A1 Drug: aerosol interferon-gamma
aerosol interferon-gamma-1b 100mcg given via nebulizer three times weekly for one year

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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00563212

Locations
United States, New York
Division of Pulmonary & Critical Care Medicine, NYU School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Stony Brook University
Philips Respironics
Investigators
Principal Investigator: Rany Condos, MD NYU School of Medicine
  More Information

No publications provided

Responsible Party: Rany Condos, MD, Assistant Professor of Medicine, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00563212     History of Changes
Other Study ID Numbers: 9583, IFB 9583
Study First Received: November 21, 2007
Last Updated: June 20, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by New York University School of Medicine:
Lung Diseases, Interstitial
Fibrosis
Interferons
Pulmonary Fibrosis
Pathologic Processes
Lung Diseases
Fibrosing alveolitis
Interferon-gamma, Recombinant
Aerosols

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Interferon-gamma
Interferons
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 18, 2014