Lung Diseases Clinical Trial
Official title:
Clinical Trial of Low Dose Oral Interferon Alpha in Idiopathic Pulmonary Fibrosis
The purpose of this study is to determine the possible efficacy of low dose, orally administered interferon alpha in subjects with Idiopathic Pulmonary Fibrosis (IPF).
This is a pilot study to determine if oral administration of low doses of Interferon alpha
might be effective in treating Idiopathic Pulmonary Fibrosis (IPF). This is a disease that
damages the lungs leading to marked decreases in the quality of life and death within 3-5
years after diagnosis. The cause is unknown. The standard treatment has for some time been
steroids such as prednisone or prednisolone because of their anti-inflammatory actions, but
there is little evidence that steroids either improve the condition, prevent further
deterioration or improve life expectancy. Additionally, they have many side effects.
In this disease, normal cells are damaged for unknown reasons and replaced by a type of
scar. This scar tissue prevents the easy movement of oxygen from the lungs into the blood,
making it difficult for the patient to perform normal activities. With progression, which
usually occurs rapidly, patients require supplemental oxygen to perform even simple tasks.
Interferons are chemicals normally produced in the body and the rate of their production has
been shown to be reduced in the lungs of patients with IPF. They are involved in regulating
the activity of the immune system which may play a role in initiating the damage to the
lungs in IPF and they also can inhibit the activity of the cells that form the scar tissue.
Our hypothesis is that treating patients with interferon might prevent damage to additional
normal tissue and prevent the formation of additional scar tissue. This would prevent
progression, improve the quality of life and extend the expected life span if successful.
Another study has been ongoing in which IPF patients have been given injections of large
doses of another type of interferon. This treatment regimen is expensive and side effects
have been fairly frequent.
In contrast, we are treating IPF patients with low doses of interferon administered orally.
The interferon is taken three times per day by letting a lozenge dissolve in the mouth.
These low doses have been shown to produce effects in patients with other diseases and they
produce very few side effects. If side effects occur, they usually are not severe and go
away quickly. Those reported most commonly by other subjects have been headaches, nausea,
rashes, respiratory infections, sore throat or diarrhea. No one has had to stop taking the
medicine because of the side effects. The medicine is provided free of charge.
This study has been going on for about 5 years. The subjects are given the same tests that
they receive as part of their standard of care. These include chest x-rays, High Resolution
CT scans, pulmonary function tests and some blood tests. They are done before starting
interferon alpha, and, depending on the test, are repeated at 3-, 6-, 9- or 12 month
intervals. In addition subjects are asked to complete questionnaires on the quality of life,
cough history and a dyspnea index at each visit.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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