Effectiveness of Chinese Herbal Therapy for 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 side effects have been
reported. New asthma medications, including leukotriene inhibitors and anti-IgE, have shown
limited 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. Additionally, a Phase I study conducted in the
United States showed good tolerability to ASHMI. Based on these preliminary studies, we
hypothesize that ASHMI will be a safe medication in patients with asthma.

Inclusion Criteria:

- Male and female subjects ages 18 through 55 and otherwise in good health as determined
by medical history and physical examination

- History of asthma documented by a physician for at least 6 months

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

- The subject agrees to participate in the study

- Subjects must have one of the following:

- one asthma-related unscheduled visit to an Emergency Department or clinic in the past
12 months

- One overnight hospitalization in the past 12 months

- Disturbed sleep more than twice in the past month

- Asthma symptoms ≥8 times in the past month

- use of a β2-agonist ≥8 times in the past month

- two short courses (3-7 days) of oral corticosteroids in the last 12 months

- FEV1 <80% predicted AND Use of inhaled corticosteroid (ICS) for at least 1 month prior
to enrollment

Exclusion Criteria:

- Acute illness (such as cold, flu, etc.) within two weeks before the screening visit

- Any history of systemic disease that in the investigator's opinion would preclude the
subject from participating in this study, including hepatitis virus infection

- History of chronic obstructive lung disease, emphysema, or other chronic respiratory
condition

- Abnormal hepatic function (ALT/AST and bilirubin >1.25 x upper limit of normal)

- Abnormal bone marrow function (WBC <4 x 103/mm3; platelets <100 x 103/mm3; Hgb <11
g/dl)

- Abnormal renal function (BUN and creatinine >1.25 x upper limit of normal)

- Clinically significant abnormal electrocardiogram

- FEV1 <50% predicted

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

- History of alcohol or drug abuse

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

- Subjects receiving treatment with Omalizumab or immunotherapy for asthma