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

Information source: New York University School of Medicine
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pulmonary Fibrosis

Intervention: aerosol interferon-gamma (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: New York University School of Medicine

Official(s) and/or principal investigator(s):
Rany Condos, MD, Principal Investigator, Affiliation: NYU School of Medicine

Overall contact:
Rany Condos, MD, Phone: 212 263 7951, Email: Rany.Condos@nyumc.org

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.

Clinical Details

Official title: A Pilot Study of Aerosol Interferon-Gamma for Treatment of Idiopathic Pulmonary Fibrosis

Study design: Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: safety, tolerability

Secondary outcome: 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

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

Minimum age: 40 Years. Maximum age: 75 Years. Gender(s): Both.

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.

Locations and Contacts

Rany Condos, MD, Phone: 212 263 7951, Email: Rany.Condos@nyumc.org

Division of Pulmonary & Critical Care Medicine, NYU School of Medicine, New York, New York 10016, United States; Recruiting
Rany Condos, MD, Principal Investigator
Sheryl R Goldyn, MD, MPH, Sub-Investigator
Additional Information

Starting date: January 2007
Last updated: November 21, 2007

Page last updated: October 04, 2010

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