The Study of Soy Isoflavones in Asthma (NCT01052116) | Clinical Trial Compass
CompletedPhase 4
The Study of Soy Isoflavones in Asthma
United States386 participantsStarted 2010-03
Plain-language summary
The trial is designed to study the effects of soy supplements on asthma control.
Who can participate
Age range12 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 12 or older
* Physician diagnosed asthma
* FEV1 equal or greater than 50% predicted pre-bronchodilator
* At least 12% increase in FEV1 15-3 minutes after inhaling 2-4 puffs of albuterol or positive methacholine challenge (20% fall in FEV1 at less than 8 mg/mL). Either of these can be available from the previous 2 years
* Currently prescribed daily controller asthma medication
* Poor asthma control (at least one of the following)
* A score of 1.5 or greater on the Juniper Asthma Control Questionnaire
* Use of beta-agonist for asthma symptoms two or more times per week
* Nocturnal awakening with asthma symptoms more than once per week
* Two or more episodes of asthma symptoms in the past 12 months with each requiring at least one of the following: emergency department visit, unscheduled physician visit, prednisone course, hospitalization
* Smoking status
* Non-smoker for 6 months or longer
* Less than 10 pack-years smoking history
Exclusion Criteria:
* Pulmonary function
* FEV1 less than 50% predicted pre-bronchodilator
* Other major chronic illnesses
* Conditions which in the judgment of the study physician would interfere with participation in the study, e.g., non-skin cancer, endocrine disease, coronary artery disease, severe hypertension, immunodeficiency states
* History of thyroid disease, breast cancer, ovarian, or endometrial cancer
* History of physician diagnosis of chronic bronchitis, emphysema, or COPD
* Me…
What they're measuring
1
Mean Change From Baseline to 24 Weeks for FEV1
Timeframe: 24 weeks
Trial details
NCT IDNCT01052116
SponsorAmerican Lung Association Asthma Clinical Research Centers