Effectiveness of Chinese Herbal Therapy for Asthma

• Status: Terminated
• Trial end date: 2009-09-29
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborator: National Center for Complementary and Integrative Health (NCCIH)

Criteria

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