Modification of Asthma With Soy Isoflavone

Completed · Not applicable

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT00741208

Run by

Northwestern University

People needed

20

Starts

2008-08-01

Expected to finish

2010-11-01

Last updated by the study team

2011-06-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Northwestern University — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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