ClinicalTrials.gov
ClinicalTrials.gov Menu

The Study of Soy Isoflavones in Asthma (SOYA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01052116
Recruitment Status : Completed
First Posted : January 20, 2010
Results First Posted : January 14, 2016
Last Update Posted : January 14, 2016
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Robert A. Wise, M.D., American Lung Association Asthma Clinical Research Centers

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Asthma
Interventions Drug: Soy isoflavone supplement
Drug: Placebo
Enrollment 386
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Soy Isoflavone
Hide Arm/Group Description Matching placebo

Oral soy isoflavone supplement

Tablet twice a day (100 mg/day)

Period Title: Overall Study
Started 193 193
Completed 179 [1] 166 [1]
Not Completed 14 27
Reason Not Completed
Lost to Follow-up             11             17
Withdrawal by Subject             3             6
Spirometry not performed             0             4
[1]
Completed: defined as having an FEV1 measurement at 24 weeks
Arm/Group Title Placebo Soy Isoflavone Total
Hide Arm/Group Description

Matching placebo

Tablet twice a day

Oral soy isoflavone supplement

Tablet twice a day (100 mg/day)

Total of all reporting groups
Overall Number of Baseline Participants 193 193 386
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 193 participants 193 participants 386 participants
38
(17 to 49)
34
(20 to 49)
36
(18 to 49)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 193 participants 193 participants 386 participants
Female
125
  64.8%
129
  66.8%
254
  65.8%
Male
68
  35.2%
64
  33.2%
132
  34.2%
FEV1  
Median (Inter-Quartile Range)
Unit of measure:  Liters
Number Analyzed 193 participants 193 participants 386 participants
2.44
(1.96 to 2.93)
2.40
(2.01 to 2.91)
2.43
(1.99 to 2.91)
1.Primary Outcome
Title Mean Change From Baseline to 24 Weeks for FEV1
Hide Description [Not Specified]
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Soy Isoflavone Placebo
Hide Arm/Group Description:

Oral soy isoflavone supplement

tablet twice daily (100 mg/day)

Matching placebo

Tablet twice daily

Overall Number of Participants Analyzed 193 193
Mean (95% Confidence Interval)
Unit of Measure: Liters
-0.001
(-0.07 to 0.07)
0.03
(-0.01 to 0.08)
Time Frame trial conducted for 2 years each participant followed for 24 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Soy Isoflavone
Hide Arm/Group Description

Matching placebo

Tablet twice a day

Oral soy isoflavone supplement

Tablet twice a day (100 mg/day)

All-Cause Mortality
Placebo Soy Isoflavone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Soy Isoflavone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/193 (6.22%)      12/193 (6.22%)    
Cardiac disorders     
Cardiovascular, circulatory, and lymphatic *  0/193 (0.00%)  0 1/193 (0.52%)  1
Gastrointestinal disorders     
Gastrointestinal *  0/193 (0.00%)  0 2/193 (1.04%)  4
Musculoskeletal and connective tissue disorders     
Musculoskeletal *  1/193 (0.52%)  1 3/193 (1.55%)  3
Nervous system disorders     
Neuropsychiatric *  0/193 (0.00%)  0 4/193 (2.07%)  4
Renal and urinary disorders     
Renal/urinary *  1/193 (0.52%)  1 0/193 (0.00%)  0
Reproductive system and breast disorders     
Reproductive *  1/193 (0.52%)  1 1/193 (0.52%)  1
Respiratory, thoracic and mediastinal disorders     
Pulmonary including asthma exacerbation *  8/193 (4.15%)  8 3/193 (1.55%)  3
Skin and subcutaneous tissue disorders     
Integumentary *  1/193 (0.52%)  1 0/193 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Soy Isoflavone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   130/186 (69.89%)      132/186 (70.97%)    
Blood and lymphatic system disorders     
Hypotension   10/182 (5.49%)  14/180 (7.78%) 
Gastrointestinal disorders     
Difficulty swallowing   38/179 (21.23%)  31/171 (18.13%) 
Musculoskeletal and connective tissue disorders     
Breast tenderness   24/180 (13.33%)  21/175 (12.00%) 
Reproductive system and breast disorders     
Change in menstrual symptoms   33/62 (53.23%)  43/71 (60.56%) 
Respiratory, thoracic and mediastinal disorders     
Difficulty breathing   47/77 (61.04%)  48/81 (59.26%) 
Skin and subcutaneous tissue disorders     
Rash   40/160 (25.00%)  39/167 (23.35%) 
Itching   45/139 (32.37%)  47/147 (31.97%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Robert A. Wise
Organization: ALA - ACRC
Phone: (410) 550-0545
Responsible Party: Robert A. Wise, M.D., American Lung Association Asthma Clinical Research Centers
ClinicalTrials.gov Identifier: NCT01052116     History of Changes
Other Study ID Numbers: ALAACRC-10
R01HL087987-01A2 ( Other Identifier: NIH/NHLBI )
R01 HL0088367-01A2 ( Other Identifier: NIH/NHLBI )
First Submitted: December 4, 2009
First Posted: January 20, 2010
Results First Submitted: December 10, 2015
Results First Posted: January 14, 2016
Last Update Posted: January 14, 2016