Effectiveness of Chinese Herbal Therapy for Asthma

Phase 1

Terminated

Conditions: Asthma

Interventions: Drug: ASHMI 4
Drug: ASHMI 12
Drug: Placebo

Registration Number: NCT00712296

Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary: The purpose of this study is to determine the efficacy of an anti-asthma herbal medicine intervention (ASHMI) in adult asthmatics

Detailed Description: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 66

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ASHMI 4	ASHMI 4	ASHMI 4 capsules twice a day
ASHMI 12	ASHMI 12	ASHMI 12 capsules twice a day
Placebo	Placebo	Placebo 6 capsules twice a day

Primary Outcome Measures

Name	Time	Method
Glucose, Urea and Creatinine Phase I	1 week after receiving active drug or placebo	Summary of Laboratory data for Glucose(mg/dL), Urea(mg/dL) and Creatinine(mg/dL) in subjects enrolled in Phase 1
Sodium, Potassium, Chloride and CO2 Phase I	1 week after receiving active drug or placebo	Summary of Laboratory data for Sodium(meq/L), Potassium(meq/L), Chloride(meq/L) and CO2 (meq/L) in subjects enrolled in Phase 1
Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase I	1 week after receiving active drug and placebo	Summary of Laboratory data for Serum glutamic pyruvic transaminase and Serum glutamic oxaloacetic transaminase in subjects enrolled in Phase 1
Laboratory Results for White Blood Cell, Hemoglobin and Platelet in Phase I	1 week after receiving active drug and placebo	Summary of Laboratory data for White Blood Cell(cells\10\^3/uL), Hemoglobin(cells\10\^3/uL) and Platelet(cells\*10\^3/uL)in subjects enrolled in Phase 1
Hemoglobin Laboratory Results in Phase I	1 week	Summary of hemoglobin as Outcome measures included laboratory data for subjects enrolled in Phase 1
Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study	28 weeks	Summary of Laboratory data for Glucose(mg/dL), Urea(mg/dL), Creatinine(mg/dL), Bilirubin Total(mg/dL) and Bilirubin Direct(mg/dL)in subjects in Phase II Limited to Measurements before discontinuation of ASHMI treatment
Laboratory Results for Sodium,Potassium, Chloride and Bicarbonate in Phase II Study	28 weeks	Summary of Laboratory data for Sodium(meq/L), Potassium(meq/L), Chloride(meq/L) and Bicarbonate(meq/L)in subjects in Phase II Limited to Measurements before discontinuation of ASHMI treatment
Laboratory Results for Alkaline Phosphatase,Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase II Study	28 weeks	Summary of Laboratory data for Alkaline phosphatase(IU/L),Serum glutamic pyruvic transaminase(IU/L)and Serum glutamic oxaloacetic transaminase(IU/L) in subjects in Phase II study Limited to Measurements before discontinuation of ASHMI treatment
Laboratory Results for White Blood Cell Count and Platelet in Subjects in Phase II Study	28 weeks	Summary of Laboratory data for White Blood Cell Count(cells\10\^3/uL) and Platelet (cells\10\^3/uL)in Phase II study Limited to Measurements before discontinuation of ASHMI treatment
Laboratory Results for Hemoglobin in Subjects in Phase II Study	28 weeks	Summary of Laboratory data for hemoglobin(g/dL)in subjects in Phase II study. Limited to Measurements before discontinuation of ASHMI treatment