CLINICAL EFFECT OF A CHINESE HERBAL THERAPY IN HUMAN ASTHMA-PHASE II, PROJECT 2

Icahn School Of Medicine At Mount Sinai, New York NY

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Abstract

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. 9/16/2008 Hypothesis: The botanical drug, ASHMI, will be an effective treatment for asthma with fewer side effects that currently used drugs such as inhaled corticosteroids (ICSs). Asthma is a major public health problem worldwide, particularly in westernized societies and has continued to increase in prevalence over the past two decades. ICSs 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 (anti-asthma herbal medicine intervention). A previous study in China of 91 moderate-severe persistent asthmatics showed that oral ASHMI significantly improved lung function and reduced symptom scores. Most importantly, no severe side effects were observed. We recently completed a Phase I study at Mount Sinai that showed that ASHMI has good tolerability without significant side effects. Based on these preliminary studies, we hypothesize that ASHMI will be safe and effective in improving the outcome of asthma in atopic patients with persistent moderate-severe asthma.