Safety and tolerability of an antiasthma herbal Formula (ASHMI) in adult subjects with asthma: a randomized, double-blinded, placebo-controlled, dose-escalation phase I study.
BACKGROUND
Complementary and alternative medicines are increasingly used for the treatment of asthma in Western countries. A novel three-herb antiasthma herbal medicine intervention (ASHMI; Sino-Lion Pharmaceutical Company; Shan Dong China) was demonstrated to be effective and safe in a murine model of asthma and in a preliminary clinical study in China.


OBJECTIVE
The objective of this study was to evaluate the safety and tolerability of ASHMI in adult subjects with allergic asthma.


METHODS
Randomized, double-blind, placebo-controlled, dose escalation, phase I trial aimed at developing a botanical drug under the United States Food and Drug Administration Investigational New Drug title.


METHODS
Subjects received one of three doses of ASHMI or placebo: 600 mg (2 capsules); 1200 mg (4 capsules); or 1800 mg (6 capsules) twice daily for 1 week. Four (4) ASHMI and 2 placebo subjects were treated at each dose level. Subjects continued to use their conventional asthma medications for the duration of the study.


METHODS
Vital signs, physical examination, laboratory data, and electrocardiogram data were monitored throughout the study to assess occurrence of adverse events (AEs). Immunomodulatory studies were performed to evaluate the effect of ASHMI on cytokine, chemokine, and growth factor levels.


RESULTS
Twenty (20) nonsmoking, allergic subjects with asthma were included in the study. Eight (8) subjects (4 ASHMI and 4 placebo) reported mild gastrointestinal symptoms. No grade 3 AEs were observed during the study period. Vital signs, electrocardiogram findings, and laboratory results obtained at pre- and post-treatment visits remained within normal range. No abnormal immunologic alterations were detected.


CONCLUSIONS
In this phase I study, ASHMI appeared to be safe and well tolerated by subjects with asthma. These findings allowed initiation of a larger phase II study to assess the efficacy of ASHMI.
Kelly-Pieper
Kristin
K
Division of Pediatric Pulmonary Medicine, Columbia University, New York, NY, USA.
Patil
Sangita P
SP
Busse
Paula
P
Yang
Nan
N
Sampson
Hugh
H
Li
Xiu-Min
XM
Wisnivesky
Juan P
JP
Kattan
Meyer
M
D000328:Adult; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D001249:Asthma / Q000097:blood / Q000188:drug therapy* / Q000276:immunology; D016207:Cytokines / Q000097:blood; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage / Q000009:adverse effects*; D005260:Female; D029882:Glycyrrhiza uralensis / Q000009:adverse effects*; D006801:Humans; D008297:Male; D008517:Phytotherapy / Q000009:adverse effects*; D018517:Plant Roots; D020940:Reishi; D012720:Severity of Illness Index; D029909:Sophora / Q000009:adverse effects*; D055815:Young Adult
D018927:Anti-Asthmatic Agents; D016207:Cytokines; D004365:Drugs, Chinese Herbal