Grant Abstract: Ginger's therapeutic potential in asthma

Grant Number: 1R33AT012627-01A1
PI Name: Emala
Project Title: Ginger's therapeutic potential in asthma

Abstract: Presently an estimated 25.9 million Americans suffer from asthma and over half have at least one asthma attack per year. Few novel therapeutics that are broadly useful in the multiple endotypes of asthma have been approved for targeting airway smooth muscle relaxation or lung inflammation in the last 40 years. Recent studies found that 60% of moderate asthmatics and 70% of severe asthmatics report using complementary and alternative medicine (CAM) to self-treat their asthma symptoms. The exact mechanism of action of these agents is unclear but may involve attenuation of allergic response (IgE levels), anti-inflammatory and antioxidant effects, and/or direct effects on airway smooth muscle. Clinical trials with chronic oral ginger therapy have demonstrated safe consumption of 2g per day for 28 days which resulted in the successful detection of the active components of ginger in human plasma and demonstrated an anti-proliferative and anti-inflammatory effect in human colon cancer and other inflammatory diseases in vivo and in airway cells in vitro. Thus, our central hypothesis is that ginger will prove efficacious in improving clinical symptoms of asthma and improve the tolerance to an inhaled methacholine bronchoconstrictive challenge mediated by chronic reduction of lung inflammation. The primary biological signature measured will be an increased tolerance to inhaled methacholine. Multiple secondary outcomes will include improvements in pulmonary function tests, reduced eosinophilia, reduced pro- inflammatory cytokines and medium chain fatty acids, reduced exhaled nitric oxide and improved scores in the severity of asthma symptoms. This is a randomized, placebo-controlled, double blinded, crossover prospective study confirming beneficial outcomes of an R61 study and will include an exploratory study of a higher oral dose of ginger. The specific aims are (1) to demonstrate the beneficial effects of oral ginger by an improved tolerance to inhaled methacholine and improved asthma symptoms, and reduced lung inflammation over a 56 day study period; (2) to determine pharmacokinetics of oral ginger and a reduction in pro-inflammatory serum medium chain fatty acids. This proposal (a) is supported by extensive preclinical studies showing a cellular mechanism that accounts for both improved airway smooth muscle relaxation and reduced lung inflammation (i.e. inhibition of phospholipase C); (b) is a study to test a natural botanical substance widely used as a dietary supplement for which sufficient early clinical data justifies further clinical testing, (c) investigates a natural substance widely used by the American public as a dietary supplement, and (d) is performed in a human clinical population with objective outcome measures of biological signatures. This translational study will confirm and extend findings from a published R61 study and define the parameters for a large scale clinical trial.

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