Status:
COMPLETED
Modification of Asthma With Soy Isoflavone
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Respiratory Health Association of Metropolitan Chicago
Conditions:
Asthma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine if dietary supplementation with soy isoflavones in persistent asthma improves airway reactivity as determined by PC20 to methacholine.
Detailed Description
Asthma is a complex disease whose prevalence and severity are determined by multiple genetic and environmental factors. The prevalence of asthma has increased during the past few decades. Although cau...
Eligibility Criteria
Inclusion
- 18 years of age or older;
- Physician diagnosed asthma;
- Positive methacholine bronchoprovocation test (20% fall in FEV1 at less than 8 mg/ml) with the past 3 years;
- Smoking Status: non-smoker for 6 months or longer and a less than 10 pack-year cumulative smoking history.
Exclusion
- Pulmonary function FEV1\< 70% predicted pre-bronchodilator;
- Other major chronic illness: conditions that in the judgement of athe principle investigator would interfere with participation in the study or history of or physician diagnosis of COPD, emphysema, or chronic bronchitis;
- Medication use: current consumption of soy isoflavone supplements or oral corticosteroid use within the past 6 months OR use of an investigational treatment within the previous 30 days;
- Drug allergy: known adverse reaction to genistein, other phytoestrogens, or soy products;
- Females of childbearing potential: pregnant or lactating or women of appropriate ago who report the possibility of pregnancy at the time of enrollment will be screened and cannot participate if pregnant;
- Non-adherence: inability or unwillingness to provide informed consent or inability to swallow study medication or inability to perform baseline measurements or completion of fewer than 5 of the 7 days of screening period diary entry or inability to be contacted by telephone;
- Other exclusions: recent asthma exacerbation (within 6 weeks) or recent upper respiratory tract infection (within 2 weeks) or change in diet over the past 1 month or expected change in diet (for example a weight loss diet) during the 6 week study period.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00741208
Start Date
August 1 2008
End Date
November 1 2010
Last Update
June 8 2011
Active Locations (1)
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1
Northwestern University
Chicago, Illinois, United States, 60611