Safety Study of Chinese Herbal Therapy to Treat Asthma

Asthma is a major public health problem worldwide, particularly in westernized societies and
has continued to increase in prevalence over the past two decades. Inhaled corticosteroids
have become the first-line treatment for persistent asthma even though significant side
effects have been reported. New asthma medications, including leukotriene inhibitors and
anti-IgE, have shown only marginal benefits. Patients have increasingly turned to
complementary and alternative medicine (CAM) for treatment of their asthma, despite the
uncertainty of its benefits due a lack of well-controlled scientific studies.

We have developed a Chinese herbal formula composed of 3 herbs called ASHMI. It has been
previously shown in murine studies that ASHMI (a formula containing Ling Zhi, Ku Shen and Gan
Cao) has therapeutic effects on the major pathogenic mechanisms of asthma-airway
hyperreactivity, pulmonary inflammation, and airway remodeling, as well as a down-regulating
of TH2 response. A subsequent study in 91 asthmatic patients in Weifang, China found ASHMI to
be a safe and effective alternative to prednisone for treating asthma and exhibited a
beneficial effect on TH1 and TH2 balance. Based on these preliminary studies, we hypothesize
that ASHMI will be a safe medication in atopic patients with asthma and will lead to
identifiable changes in serum immunologic markers.

Inclusion Criteria:

- Male and female subjects ages 18-40 and otherwise in good health as determined by
medical history and physical examination

- History of asthma documented by a physician

- Documentation of allergy to two or more common environmental allergens as evidenced by
positive prick skin or RAST testing

- The subject agrees to participate in the study

- Females of childbearing potential must be inactive sexually or take effective birth
control measures, as deemed appropriate by the investigator, for the duration of the
study.

Exclusion Criteria:

- Acute illness (such as cold, flu, etc.) within one week before the administration of
study drug

- Any history of systemic disease that in the investigator's opinion would preclude the
subject from participating in this study, including viral hepatitis infection (by
patient self-report)

- Abnormal hepatic function

- Abnormal bone marrow function

- Abnormal renal function

- Clinically significant abnormal electrocardiogram

- Current uncontrolled moderate to severe asthma with FEV1 <80% predicted

- Participation in another experimental study within 30 days of this study

- History of alcohol or drug abuse (by self report)

- Pregnant or lactating female subjects. Females of childbearing potential will need a
negative serum pregnancy test to be considered for this study

- Current smokers