Trial Outcomes & Findings for The Study of Soy Isoflavones in Asthma (NCT NCT01052116)

NCT ID: NCT01052116

Last Updated: 2016-01-14

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 386 participants
• Primary outcome timeframe: 24 weeks
• Results posted on: 2016-01-14

Participant Flow

Participant milestones

Measure	Placebo Matching placebo	Soy Isoflavone Oral soy isoflavone supplement Tablet twice a day (100 mg/day)
Overall Study STARTED	193	193
Overall Study COMPLETED	179	166
Overall Study NOT COMPLETED	14	27

Reasons for withdrawal

Measure	Placebo Matching placebo	Soy Isoflavone Oral soy isoflavone supplement Tablet twice a day (100 mg/day)
Overall Study Lost to Follow-up	11	17
Overall Study Withdrawal by Subject	3	6
Overall Study Spirometry not performed	0	4

Baseline Characteristics

The Study of Soy Isoflavones in Asthma

Baseline characteristics by cohort

Measure	Placebo n=193 Participants Matching placebo Tablet twice a day	Soy Isoflavone n=193 Participants Oral soy isoflavone supplement Tablet twice a day (100 mg/day)	Total n=386 Participants Total of all reporting groups
Age, Continuous	38 years n=5 Participants	34 years n=7 Participants	36 years n=5 Participants
Sex: Female, Male Female	125 Participants n=5 Participants	129 Participants n=7 Participants	254 Participants n=5 Participants
Sex: Female, Male Male	68 Participants n=5 Participants	64 Participants n=7 Participants	132 Participants n=5 Participants
FEV1	2.44 Liters n=5 Participants	2.40 Liters n=7 Participants	2.43 Liters n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Outcome measures

Measure	Soy Isoflavone n=193 Participants Oral soy isoflavone supplement tablet twice daily (100 mg/day)	Placebo n=193 Participants Matching placebo Tablet twice daily
Mean Change From Baseline to 24 Weeks for FEV1	-0.001 Liters Interval -0.07 to 0.07	0.03 Liters Interval -0.01 to 0.08

Adverse Events

Placebo

Serious events: 12 serious events

Other events: 130 other events

Deaths: 0 deaths

Soy Isoflavone

Serious events: 12 serious events

Other events: 132 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=186 participants at risk；n=193 participants at risk Matching placebo Tablet twice a day	Soy Isoflavone n=186 participants at risk；n=193 participants at risk Oral soy isoflavone supplement Tablet twice a day (100 mg/day)
Respiratory, thoracic and mediastinal disorders Pulmonary including asthma exacerbation	4.1% 8/193 • Number of events 8 • trial conducted for 2 years each participant followed for 24 weeks	1.6% 3/193 • Number of events 3 • trial conducted for 2 years each participant followed for 24 weeks
Cardiac disorders Cardiovascular, circulatory, and lymphatic	0.00% 0/193 • trial conducted for 2 years each participant followed for 24 weeks	0.52% 1/193 • Number of events 1 • trial conducted for 2 years each participant followed for 24 weeks
Renal and urinary disorders Renal/urinary	0.52% 1/193 • Number of events 1 • trial conducted for 2 years each participant followed for 24 weeks	0.00% 0/193 • trial conducted for 2 years each participant followed for 24 weeks
Gastrointestinal disorders Gastrointestinal	0.00% 0/193 • trial conducted for 2 years each participant followed for 24 weeks	1.0% 2/193 • Number of events 4 • trial conducted for 2 years each participant followed for 24 weeks
Nervous system disorders Neuropsychiatric	0.00% 0/193 • trial conducted for 2 years each participant followed for 24 weeks	2.1% 4/193 • Number of events 4 • trial conducted for 2 years each participant followed for 24 weeks
Reproductive system and breast disorders Reproductive	0.52% 1/193 • Number of events 1 • trial conducted for 2 years each participant followed for 24 weeks	0.52% 1/193 • Number of events 1 • trial conducted for 2 years each participant followed for 24 weeks
Musculoskeletal and connective tissue disorders Musculoskeletal	0.52% 1/193 • Number of events 1 • trial conducted for 2 years each participant followed for 24 weeks	1.6% 3/193 • Number of events 3 • trial conducted for 2 years each participant followed for 24 weeks
Skin and subcutaneous tissue disorders Integumentary	0.52% 1/193 • Number of events 1 • trial conducted for 2 years each participant followed for 24 weeks	0.00% 0/193 • trial conducted for 2 years each participant followed for 24 weeks

Other adverse events

Measure	Placebo n=186 participants at risk；n=193 participants at risk Matching placebo Tablet twice a day	Soy Isoflavone n=186 participants at risk；n=193 participants at risk Oral soy isoflavone supplement Tablet twice a day (100 mg/day)
Skin and subcutaneous tissue disorders Rash	25.0% 40/160 • trial conducted for 2 years each participant followed for 24 weeks	23.4% 39/167 • trial conducted for 2 years each participant followed for 24 weeks
Skin and subcutaneous tissue disorders Itching	32.4% 45/139 • trial conducted for 2 years each participant followed for 24 weeks	32.0% 47/147 • trial conducted for 2 years each participant followed for 24 weeks
Respiratory, thoracic and mediastinal disorders Difficulty breathing	61.0% 47/77 • trial conducted for 2 years each participant followed for 24 weeks	59.3% 48/81 • trial conducted for 2 years each participant followed for 24 weeks
Gastrointestinal disorders Difficulty swallowing	21.2% 38/179 • trial conducted for 2 years each participant followed for 24 weeks	18.1% 31/171 • trial conducted for 2 years each participant followed for 24 weeks
Blood and lymphatic system disorders Hypotension	5.5% 10/182 • trial conducted for 2 years each participant followed for 24 weeks	7.8% 14/180 • trial conducted for 2 years each participant followed for 24 weeks
Musculoskeletal and connective tissue disorders Breast tenderness	13.3% 24/180 • trial conducted for 2 years each participant followed for 24 weeks	12.0% 21/175 • trial conducted for 2 years each participant followed for 24 weeks
Reproductive system and breast disorders Change in menstrual symptoms	53.2% 33/62 • trial conducted for 2 years each participant followed for 24 weeks	60.6% 43/71 • trial conducted for 2 years each participant followed for 24 weeks

Additional Information

Robert A. Wise

ALA - ACRC

Phone: (410) 550-0545

Email: rwise@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place