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
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: 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 July 28, 2014