A Pilot Study of Aerosol Interferon-Gamma Treatment in Pulmonary Fibrosis

This study has been completed.
Sponsor:
Information provided by:
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00212563
First received: September 13, 2005
Last updated: December 20, 2005
Last verified: March 2004
  Purpose

A Safety and Efficacy trial of aerosol Interferon-gamma treatment in Pulmonary Fibrosis


Condition Intervention Phase
Idiopathic Pulmonary Fibrosis
Drug: Aerosol Interferon-gamma treatment
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Tolerability and safety

Secondary Outcome Measures:
  • aerosol deposition
  • cellular response

Estimated Enrollment: 5
  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients diagnosed with IPF based on accepted criteria within 30 months prior to screening
  • Age 20-70
  • A failed trial of prednisone with or without cyclophosphamide/ azathioprine
  • Patient taking 0-15mg prednisone or the equivalent for 28 days prior to study enrollment and willing to remain on that same dose of corticosteroid
  • FVC >= 50% and <= 90% of predicted baseline value at screening
  • PaO2 > 60 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:
  • Patient fits criteria for research bronchoscopy and is willing to undergo procedure
  • Patient able to have medication administered three times per week at the GCRC unit at Bellevue Hospital

Exclusion Criteria:

  • No adequate treatment trial with prednisone, cyclophosphamide, or azathioprine
  • patient unwilling or unable to undergo research bronchoscopy
  • Patient with known asthma or severe COPD
  • Patient requiring oxygen therapy for maintenance of adequate arterial oxygenation
  • 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 age 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:

    1. 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.
    2. CBC outside specified limits: WBC < 2,500/mm3, hematocrit <30 or >59, platelets < 100,000/mm3.
    3. Creatinine > 1.5X upper limits normal at screening
  • Drugs for therapy for pulmonary fibrosis, excluding corticosteroids/cyclophosphamide/azathioprine, within the previous six months
  • Prior therapy with any class of interferon medication
  • Investigational therapy for any indication within the last 28 days
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00212563

Locations
United States, New York
NYU School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Rany Condos, MD NYU School of Medicine
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00212563     History of Changes
Other Study ID Numbers: 9583-04A
Study First Received: September 13, 2005
Last Updated: December 20, 2005
Health Authority: United States: Institutional Review Board

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 April 17, 2014