Effectiveness of Chinese Herbal Therapy for Asthma

NCT00712296 | Terminated Phase 1 Results DMC

• 2 other identifiers: GCO 04-0206P01AT002647-02
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Asthma

Keywords

Asthma; alternative medicine; complementary medicine; herbal therapy

Outcome Measures

Primary Outcomes (10)

• Glucose, Urea and Creatinine Phase I

  Summary of Laboratory data for Glucose(mg/dL), Urea(mg/dL) and Creatinine(mg/dL) in subjects enrolled in Phase 1

  1 week after receiving active drug or placebo

• Sodium, Potassium, Chloride and CO2 Phase I

  Summary of Laboratory data for Sodium(meq/L), Potassium(meq/L), Chloride(meq/L) and CO2 (meq/L) in subjects enrolled in Phase 1

  1 week after receiving active drug or placebo

• Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase I

  Summary of Laboratory data for Serum glutamic pyruvic transaminase and Serum glutamic oxaloacetic transaminase in subjects enrolled in Phase 1

  1 week after receiving active drug and placebo

• Laboratory Results for White Blood Cell, Hemoglobin and Platelet in Phase I

  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

  1 week after receiving active drug and placebo

• Hemoglobin Laboratory Results in Phase I

  Summary of hemoglobin as Outcome measures included laboratory data for subjects enrolled in Phase 1

  1 week

• Laboratory Results for Glucose, Urea, Creatinine, Bilirubin Total and Bilirubin Direct Phase II Study

  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

  28 weeks

• Laboratory Results for Sodium,Potassium, Chloride and Bicarbonate in Phase II Study

  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

  28 weeks

• Laboratory Results for Alkaline Phosphatase,Serum Glutamic Pyruvic Transaminase and Serum Glutamic Oxaloacetic Transaminase in Phase II Study

  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

  28 weeks

• Laboratory Results for White Blood Cell Count and Platelet in Subjects in Phase II Study

  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

  28 weeks

• Laboratory Results for Hemoglobin in Subjects in Phase II Study

  Summary of Laboratory data for hemoglobin(g/dL)in subjects in Phase II study. Limited to Measurements before discontinuation of ASHMI treatment

  28 weeks

Study Arms (3)

ASHMI 4

EXPERIMENTAL

ASHMI 4 capsules twice a day

Drug: ASHMI 4

ASHMI 12

EXPERIMENTAL

ASHMI 12 capsules twice a day

Drug: ASHMI 12

Placebo

PLACEBO COMPARATOR

Placebo 6 capsules twice a day

Drug: Placebo

Interventions

ASHMI 4 DRUG

4 capsules orally twice a day

ASHMI 4

ASHMI 12 DRUG

12 capsules orally twice a day

ASHMI 12

Placebo DRUG

Placebo 6 capsules twice a day

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (1)

• Wen MC, Wei CH, Hu ZQ, Srivastava K, Ko J, Xi ST, Mu DZ, Du JB, Li GH, Wallenstein S, Sampson H, Kattan M, Li XM. Efficacy and tolerability of anti-asthma herbal medicine intervention in adult patients with moderate-severe allergic asthma. J Allergy Clin Immunol. 2005 Sep;116(3):517-24. doi: 10.1016/j.jaci.2005.05.029.

  PMID: 16159618 BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Limitations and Caveats

The Phase II study was stopped after 46 subjects were randomized. Since the number of subjects and the follow-up information did not provide adequate power, all statistical analysis plan was changed to descriptive summaries for each group.

Results Point of Contact

• Title: Xiu-Min Li, MD
• Organization: Icahn School of Medicine at Mount Sinai

Xiu-min.li@mssm.edu

212-241-1755

Study Officials

• Juan P Wisnivesky, MD, DrPH

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Pediatrics, Allergy and Immunology

Study Record Dates

• First Submitted: July 7, 2008
• First Posted: July 9, 2008
• Study Start: August 1, 2008
• Primary Completion: September 29, 2009
• Study Completion: September 29, 2009
• Last Updated: September 16, 2020
• Results First Posted: August 25, 2020

Record last verified: 2020-08

Locations

US (1)