Modification of Asthma With Soy Isoflavone (NCT00741208) | Clinical Trial Compass
CompletedNot Applicable
Modification of Asthma With Soy Isoflavone
United States20 participantsStarted 2008-08
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 ch…
What they're measuring
1
Change in airway reactivity induced by dietary supplementation with soy isoflavones. Airway reactivity will be measured with methacholine bronchoprovocation testing.