Trial Outcomes & Findings for Effects of Broccoli Sprout Extract on Allergy Rhinitis (NCT NCT02885025)
NCT ID: NCT02885025
Last Updated: 2020-06-19
Results Overview
The Immediate Total Nasal Symptom Score (TNSS): The TNSS has been used in prior interventional studies to evaluate different treatment modes for allergic rhinitis. The score will consist of subjects rating 4 symptoms (nasal congestion/postnasal drainage, nasal pruritus, rhinorrhea, or sneezing) on a scale of 0 to 3, where 0=no symptoms present, 1=mild symptoms that do not interfere with activity, 2=moderate symptoms that are slightly bothersome symptoms with slight interference with activity and/or nighttime sleep, or 3=severe symptoms with interference with activity and nighttime sleep. Thus minimal value would be 0 vs. maximal value would be a score of 12. A higher score correlates with higher rhinitis activity. Diminished scores following an intervention is consistent with an improvement in rhinitis symptoms.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
47 participants
Primary outcome timeframe
measures at various points following challenge at baseline and 21 days
Results posted on
2020-06-19
Participant Flow
Patients were recruited from the VA Greater Los Angeles Healthcare System Allergy Immunology Clinic
Participant milestones
| Measure |
BSE + Nasal Fluticasone
subjects will be randomized into 1 of 4 arms:
1. BSE + Nasal Fluticasone
2. BSE + normal saline nasal spray
3. Placebo Pill + Nasal Fluticasone
4. Placebo Pill + normal saline nasal spray
Broccoli Sprout Extract: Broccoli Sprout Extract contains the antioxidant Sulforaphane which is the active ingredient being studies.
fluticasone nasal: fluticasone is a nasal steroid that is currently approved for treatment of allergic rhinitis.
|
BSE + Normal Saline Nasal Spray
subjects will be randomized into 1 of 4 arms:
1. BSE + Nasal Fluticasone
2. BSE + normal saline nasal spray
3. Placebo Pill + Nasal Fluticasone
4. Placebo Pill + normal saline nasal spray
Broccoli Sprout Extract: Broccoli Sprout Extract contains the antioxidant Sulforaphane which is the active ingredient being studies.
normal saline nasal spray: normal saline to replace nasal fluticasone in specific arms of the study
|
Placebo Pill + Nasal Fluticasone
subjects will be randomized into 1 of 4 arms:
1. BSE + Nasal Fluticasone
2. BSE + normal saline nasal spray
3. Placebo Pill + Nasal Fluticasone
4. Placebo Pill + normal saline nasal spray
fluticasone nasal: fluticasone is a nasal steroid that is currently approved for treatment of allergic rhinitis.
broccoli sprout extract placebo: a tablet similar to the actual broccoli sprout extract though without BSE.
|
Placebo Pill + Normal Saline Nasal Spray
subjects will be randomized into 1 of 4 arms:
1. BSE + Nasal Fluticasone
2. BSE + normal saline nasal spray
3. Placebo Pill + Nasal Fluticasone
4. Placebo Pill + normal saline nasal spray
broccoli sprout extract placebo: a tablet similar to the actual broccoli sprout extract though without BSE.
normal saline nasal spray: normal saline to replace nasal fluticasone in specific arms of the study
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
14
|
9
|
8
|
|
Overall Study
COMPLETED
|
16
|
12
|
9
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Broccoli Sprout Extract on Allergy Rhinitis
Baseline characteristics by cohort
| Measure |
BSE + Nasal Fluticasone
n=16 Participants
subjects will be randomized into 1 of 4 arms:
1. BSE + Nasal Fluticasone
2. BSE + normal saline nasal spray
3. Placebo Pill + Nasal Fluticasone
4. Placebo Pill + normal saline nasal spray
Broccoli Sprout Extract: Broccoli Sprout Extract contains the antioxidant Sulforaphane which is the active ingredient being studies.
fluticasone nasal: fluticasone is a nasal steroid that is currently approved for treatment of allergic rhinitis.
|
BSE + Normal Saline Nasal Spray
n=14 Participants
subjects will be randomized into 1 of 4 arms:
1. BSE + Nasal Fluticasone
2. BSE + normal saline nasal spray
3. Placebo Pill + Nasal Fluticasone
4. Placebo Pill + normal saline nasal spray
Broccoli Sprout Extract: Broccoli Sprout Extract contains the antioxidant Sulforaphane which is the active ingredient being studies.
normal saline nasal spray: normal saline to replace nasal fluticasone in specific arms of the study
|
Placebo Pill + Nasal Fluticasone
n=9 Participants
subjects will be randomized into 1 of 4 arms:
1. BSE + Nasal Fluticasone
2. BSE + normal saline nasal spray
3. Placebo Pill + Nasal Fluticasone
4. Placebo Pill + normal saline nasal spray
fluticasone nasal: fluticasone is a nasal steroid that is currently approved for treatment of allergic rhinitis.
broccoli sprout extract placebo: a tablet similar to the actual broccoli sprout extract though without BSE.
|
Placebo Pill + Normal Saline Nasal Spray
n=8 Participants
subjects will be randomized into 1 of 4 arms:
1. BSE + Nasal Fluticasone
2. BSE + normal saline nasal spray
3. Placebo Pill + Nasal Fluticasone
4. Placebo Pill + normal saline nasal spray
broccoli sprout extract placebo: a tablet similar to the actual broccoli sprout extract though without BSE.
normal saline nasal spray: normal saline to replace nasal fluticasone in specific arms of the study
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
|
PNIF
|
105 L/min
STANDARD_DEVIATION 21.2 • n=5 Participants
|
120 L/min
STANDARD_DEVIATION 14.1 • n=7 Participants
|
172.5 L/min
STANDARD_DEVIATION 31.8 • n=5 Participants
|
170 L/min
STANDARD_DEVIATION 28.3 • n=4 Participants
|
155 L/min
STANDARD_DEVIATION 49.5 • n=21 Participants
|
PRIMARY outcome
Timeframe: measures at various points following challenge at baseline and 21 daysPopulation: intent to treat population (all participants assigned to 1 of the 4 groups above).
The Immediate Total Nasal Symptom Score (TNSS): The TNSS has been used in prior interventional studies to evaluate different treatment modes for allergic rhinitis. The score will consist of subjects rating 4 symptoms (nasal congestion/postnasal drainage, nasal pruritus, rhinorrhea, or sneezing) on a scale of 0 to 3, where 0=no symptoms present, 1=mild symptoms that do not interfere with activity, 2=moderate symptoms that are slightly bothersome symptoms with slight interference with activity and/or nighttime sleep, or 3=severe symptoms with interference with activity and nighttime sleep. Thus minimal value would be 0 vs. maximal value would be a score of 12. A higher score correlates with higher rhinitis activity. Diminished scores following an intervention is consistent with an improvement in rhinitis symptoms.
Outcome measures
| Measure |
BSE + Nasal Fluticasone
n=16 Participants
patients received combination of broccoli sprout extract tablet and nasal fluticasone for a total of 3 weeks
|
BSE + Normal Saline Nasal Spray
n=12 Participants
Patients received broccoli sprout extract tablets and nasal saline spray for 3 weeks.
|
Placebo Pill + Nasal Fluticasone
n=9 Participants
Patients received placebo tablet and nasal fluticasone for 3 weeks.
|
Placebo Pill + Normal Saline Nasal Spray
n=8 Participants
Patients received placebo tablet and normal saline nasal spray for 3 weeks
|
|---|---|---|---|---|
|
Total Nasal Symptom Score (TNSS) Change From Baseline to 3 Weeks of Randomly Assigned Treatment
|
-.5277 score on a scale
Standard Deviation 0.1048
|
-.5484 score on a scale
Standard Deviation .0014
|
-.8359 score on a scale
Standard Deviation 0.3903
|
-.181 score on a scale
Standard Deviation .0846
|
PRIMARY outcome
Timeframe: 21 days (from randomization to completion)peak nasal inspiratory flow (PNIF) measures the peak flow during nasal inspiration with an approved device utilized in other studies. Measurements will be performed with TNSS (above).
Outcome measures
| Measure |
BSE + Nasal Fluticasone
n=16 Participants
patients received combination of broccoli sprout extract tablet and nasal fluticasone for a total of 3 weeks
|
BSE + Normal Saline Nasal Spray
n=12 Participants
Patients received broccoli sprout extract tablets and nasal saline spray for 3 weeks.
|
Placebo Pill + Nasal Fluticasone
n=9 Participants
Patients received placebo tablet and nasal fluticasone for 3 weeks.
|
Placebo Pill + Normal Saline Nasal Spray
n=8 Participants
Patients received placebo tablet and normal saline nasal spray for 3 weeks
|
|---|---|---|---|---|
|
Peak Nasal Inspiratory Flow (PNIF) Change From Baseline to 3 Weeks of Randomly Assigned Treatment
|
.3362 L/min
Standard Deviation .0026
|
.1213 L/min
Standard Deviation .0607
|
.0636 L/min
Standard Deviation .0485
|
-.0538 L/min
Standard Deviation .0453
|
SECONDARY outcome
Timeframe: 21 days (from randomization to completion)Interleukin 5 (IL5) is considered a T2 cytokine that increases with exacerbations of atopic disease, including allergic rhinitis. Cytokine measurements are in pg/ml. Values are recorded with log transformation. Note that measurements are on a continuous score. Lower values are consistent with less T2 inflammation which is consistent with diminished or lower atopic/allergic response.
Outcome measures
| Measure |
BSE + Nasal Fluticasone
n=16 Participants
patients received combination of broccoli sprout extract tablet and nasal fluticasone for a total of 3 weeks
|
BSE + Normal Saline Nasal Spray
n=12 Participants
Patients received broccoli sprout extract tablets and nasal saline spray for 3 weeks.
|
Placebo Pill + Nasal Fluticasone
n=9 Participants
Patients received placebo tablet and nasal fluticasone for 3 weeks.
|
Placebo Pill + Normal Saline Nasal Spray
n=8 Participants
Patients received placebo tablet and normal saline nasal spray for 3 weeks
|
|---|---|---|---|---|
|
Interleukin 5 (IL5)
|
-.5285 log(pg/ml)
Standard Deviation .2236
|
-.3213 log(pg/ml)
Standard Deviation .2005
|
-.1082 log(pg/ml)
Standard Deviation .0083
|
-.3755 log(pg/ml)
Standard Deviation 0.1866
|
SECONDARY outcome
Timeframe: 21 days (from randomization to completion)Population: Patient diagnosed with grass induced allergic rhinitis were randomized into 1 of 4 groups.
Interleukin 4 (IL4) is considered a T2 cytokine that increases with exacerbations of atopic disease, including allergic rhinitis. Cytokine measurements are in pg/ml. Values are recorded with log transformation. Note that measurements are on a continuous score. Lower values are consistent with less T2 inflammation which is consistent with diminished or lower atopic/allergic response.
Outcome measures
| Measure |
BSE + Nasal Fluticasone
n=16 Participants
patients received combination of broccoli sprout extract tablet and nasal fluticasone for a total of 3 weeks
|
BSE + Normal Saline Nasal Spray
n=12 Participants
Patients received broccoli sprout extract tablets and nasal saline spray for 3 weeks.
|
Placebo Pill + Nasal Fluticasone
n=9 Participants
Patients received placebo tablet and nasal fluticasone for 3 weeks.
|
Placebo Pill + Normal Saline Nasal Spray
n=8 Participants
Patients received placebo tablet and normal saline nasal spray for 3 weeks
|
|---|---|---|---|---|
|
Interleukin 4 (IL4)
|
-.5655 log(pg/ml)
Standard Deviation 0.4738
|
-.1076 log(pg/ml)
Standard Deviation .0228
|
-.3682 log(pg/ml)
Standard Deviation .0294
|
-.3695 log(pg/ml)
Standard Deviation .233
|
SECONDARY outcome
Timeframe: 21 days (from randomization to completion)Interleukin 6 is a cytokine present during inflammatory process. This is recorded in pg/ml. Below is the log transformation of the pg/ml unit. Note that measurements are on a continuous score. Lower values are consistent with less inflammation which could occur with an inflammatory response.
Outcome measures
| Measure |
BSE + Nasal Fluticasone
n=16 Participants
patients received combination of broccoli sprout extract tablet and nasal fluticasone for a total of 3 weeks
|
BSE + Normal Saline Nasal Spray
n=12 Participants
Patients received broccoli sprout extract tablets and nasal saline spray for 3 weeks.
|
Placebo Pill + Nasal Fluticasone
n=9 Participants
Patients received placebo tablet and nasal fluticasone for 3 weeks.
|
Placebo Pill + Normal Saline Nasal Spray
n=8 Participants
Patients received placebo tablet and normal saline nasal spray for 3 weeks
|
|---|---|---|---|---|
|
Interleukin 6 (IL6)
|
-1.0868 log(pg/ml)
Standard Deviation .2903
|
-.0519 log(pg/ml)
Standard Deviation .2437
|
-.2719 log(pg/ml)
Standard Deviation 1.6894
|
.3567 log(pg/ml)
Standard Deviation .2826
|
SECONDARY outcome
Timeframe: 21 days (from randomization to completion)Interleukin 8 s a cytokine that will increase with inflammation. Below is the log transformation of the pg/ml unit. Note that measurements are on a continuous score. Lower values are consistent with less inflammation which could occur with an inflammatory response.
Outcome measures
| Measure |
BSE + Nasal Fluticasone
n=16 Participants
patients received combination of broccoli sprout extract tablet and nasal fluticasone for a total of 3 weeks
|
BSE + Normal Saline Nasal Spray
n=12 Participants
Patients received broccoli sprout extract tablets and nasal saline spray for 3 weeks.
|
Placebo Pill + Nasal Fluticasone
n=9 Participants
Patients received placebo tablet and nasal fluticasone for 3 weeks.
|
Placebo Pill + Normal Saline Nasal Spray
n=8 Participants
Patients received placebo tablet and normal saline nasal spray for 3 weeks
|
|---|---|---|---|---|
|
Interleukin 8 (IL8)
|
-.7626 pg/ml log transformation
Standard Deviation .0168
|
-.047 pg/ml log transformation
Standard Deviation .0033
|
-.1013 pg/ml log transformation
Standard Deviation .2629
|
.0472 pg/ml log transformation
Standard Deviation .1748
|
SECONDARY outcome
Timeframe: 21 days (from randomization to completion)Population: Patient diagnosed with grass induced allergic rhinitis were randomized into 1 of 4 groups.
Interleukin 13 (IL13) is considered a T2 cytokine that increases with exacerbations of atopic disease, including allergic rhinitis. Cytokine measurements are in pg/ml. Values are recorded with log transformation. Note that measurements are on a continuous score. Lower values are consistent with less T2 inflammation which is consistent with diminished or lower atopic/allergic response.
Outcome measures
| Measure |
BSE + Nasal Fluticasone
n=16 Participants
patients received combination of broccoli sprout extract tablet and nasal fluticasone for a total of 3 weeks
|
BSE + Normal Saline Nasal Spray
n=12 Participants
Patients received broccoli sprout extract tablets and nasal saline spray for 3 weeks.
|
Placebo Pill + Nasal Fluticasone
n=9 Participants
Patients received placebo tablet and nasal fluticasone for 3 weeks.
|
Placebo Pill + Normal Saline Nasal Spray
n=8 Participants
Patients received placebo tablet and normal saline nasal spray for 3 weeks
|
|---|---|---|---|---|
|
Interleukin 13 (IL13)
|
-1.0822 log(pg/ml)
Standard Deviation .2568
|
-.2985 log(pg/ml)
Standard Deviation .0466
|
.1577 log(pg/ml)
Standard Deviation .1042
|
-.0459 log(pg/ml)
Standard Deviation .3745
|
SECONDARY outcome
Timeframe: 21 days (from randomization to completion)Population: Patient diagnosed with grass induced allergic rhinitis were randomized into 1 of 4 groups
IL1b is a cytokine that will increase with inflammation. Below is the log transformation of the pg/ml unit. Note that measurements are on a continuous score. Lower values are consistent with less inflammation which could occur with an inflammatory response.
Outcome measures
| Measure |
BSE + Nasal Fluticasone
n=16 Participants
patients received combination of broccoli sprout extract tablet and nasal fluticasone for a total of 3 weeks
|
BSE + Normal Saline Nasal Spray
n=12 Participants
Patients received broccoli sprout extract tablets and nasal saline spray for 3 weeks.
|
Placebo Pill + Nasal Fluticasone
n=9 Participants
Patients received placebo tablet and nasal fluticasone for 3 weeks.
|
Placebo Pill + Normal Saline Nasal Spray
n=8 Participants
Patients received placebo tablet and normal saline nasal spray for 3 weeks
|
|---|---|---|---|---|
|
Interleukin 1 Beta (IL1b)
|
-.4058 pg/ml with log transformation
Standard Deviation .2563
|
.0183 pg/ml with log transformation
Standard Deviation .037
|
-.2382 pg/ml with log transformation
Standard Deviation .3013
|
.0713 pg/ml with log transformation
Standard Deviation .1139
|
Adverse Events
BSE + Nasal Fluticasone
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BSE + Normal Saline Nasal Spray
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo Pill + Nasal Fluticasone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Pill + Normal Saline Nasal Spray
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BSE + Nasal Fluticasone
n=16 participants at risk
subjects will be randomized into 1 of 4 arms:
1. BSE + Nasal Fluticasone
2. BSE + normal saline nasal spray
3. Placebo Pill + Nasal Fluticasone
4. Placebo Pill + normal saline nasal spray
Broccoli Sprout Extract: Broccoli Sprout Extract contains the antioxidant Sulforaphane which is the active ingredient being studies.
no adverse events reported fluticasone nasal: fluticasone is a nasal steroid that is currently approved for treatment of allergic rhinitis.
|
BSE + Normal Saline Nasal Spray
n=14 participants at risk
subjects will be randomized into 1 of 4 arms:
1. BSE + Nasal Fluticasone
2. BSE + normal saline nasal spray
3. Placebo Pill + Nasal Fluticasone
4. Placebo Pill + normal saline nasal spray
Broccoli Sprout Extract: Broccoli Sprout Extract contains the antioxidant Sulforaphane which is the active ingredient being studies.
normal saline nasal spray: normal saline to replace nasal fluticasone in specific arms of the study
|
Placebo Pill + Nasal Fluticasone
n=9 participants at risk
subjects will be randomized into 1 of 4 arms:
1. BSE + Nasal Fluticasone
2. BSE + normal saline nasal spray
3. Placebo Pill + Nasal Fluticasone
4. Placebo Pill + normal saline nasal spray
fluticasone nasal: fluticasone is a nasal steroid that is currently approved for treatment of allergic rhinitis.
broccoli sprout extract placebo: a tablet similar to the actual broccoli sprout extract though without BSE.
|
Placebo Pill + Normal Saline Nasal Spray
n=8 participants at risk
subjects will be randomized into 1 of 4 arms:
1. BSE + Nasal Fluticasone
2. BSE + normal saline nasal spray
3. Placebo Pill + Nasal Fluticasone
4. Placebo Pill + normal saline nasal spray
broccoli sprout extract placebo: a tablet similar to the actual broccoli sprout extract though without BSE.
normal saline nasal spray: normal saline to replace nasal fluticasone in specific arms of the study
|
|---|---|---|---|---|
|
Gastrointestinal disorders
gi complaints
|
0.00%
0/16 • Adverse events were collected throughout the study. 1 year 6 months total.
Intermittent sneezing, expected adverse event. Flatulence, expected adverse event General: "cold like symptoms", unrelated, expected given time of year Nasal irritation after nasal saline spray, unrelated, unexpected : GI: hemorrhoids: unexpected, unrelated Chest pain: secondary to rib injury: unrelated, unexpected GI: bloating: expected
|
0.00%
0/14 • Adverse events were collected throughout the study. 1 year 6 months total.
Intermittent sneezing, expected adverse event. Flatulence, expected adverse event General: "cold like symptoms", unrelated, expected given time of year Nasal irritation after nasal saline spray, unrelated, unexpected : GI: hemorrhoids: unexpected, unrelated Chest pain: secondary to rib injury: unrelated, unexpected GI: bloating: expected
|
0.00%
0/9 • Adverse events were collected throughout the study. 1 year 6 months total.
Intermittent sneezing, expected adverse event. Flatulence, expected adverse event General: "cold like symptoms", unrelated, expected given time of year Nasal irritation after nasal saline spray, unrelated, unexpected : GI: hemorrhoids: unexpected, unrelated Chest pain: secondary to rib injury: unrelated, unexpected GI: bloating: expected
|
12.5%
1/8 • Number of events 1 • Adverse events were collected throughout the study. 1 year 6 months total.
Intermittent sneezing, expected adverse event. Flatulence, expected adverse event General: "cold like symptoms", unrelated, expected given time of year Nasal irritation after nasal saline spray, unrelated, unexpected : GI: hemorrhoids: unexpected, unrelated Chest pain: secondary to rib injury: unrelated, unexpected GI: bloating: expected
|
|
General disorders
nasal symptom
|
0.00%
0/16 • Adverse events were collected throughout the study. 1 year 6 months total.
Intermittent sneezing, expected adverse event. Flatulence, expected adverse event General: "cold like symptoms", unrelated, expected given time of year Nasal irritation after nasal saline spray, unrelated, unexpected : GI: hemorrhoids: unexpected, unrelated Chest pain: secondary to rib injury: unrelated, unexpected GI: bloating: expected
|
7.1%
1/14 • Number of events 1 • Adverse events were collected throughout the study. 1 year 6 months total.
Intermittent sneezing, expected adverse event. Flatulence, expected adverse event General: "cold like symptoms", unrelated, expected given time of year Nasal irritation after nasal saline spray, unrelated, unexpected : GI: hemorrhoids: unexpected, unrelated Chest pain: secondary to rib injury: unrelated, unexpected GI: bloating: expected
|
0.00%
0/9 • Adverse events were collected throughout the study. 1 year 6 months total.
Intermittent sneezing, expected adverse event. Flatulence, expected adverse event General: "cold like symptoms", unrelated, expected given time of year Nasal irritation after nasal saline spray, unrelated, unexpected : GI: hemorrhoids: unexpected, unrelated Chest pain: secondary to rib injury: unrelated, unexpected GI: bloating: expected
|
0.00%
0/8 • Adverse events were collected throughout the study. 1 year 6 months total.
Intermittent sneezing, expected adverse event. Flatulence, expected adverse event General: "cold like symptoms", unrelated, expected given time of year Nasal irritation after nasal saline spray, unrelated, unexpected : GI: hemorrhoids: unexpected, unrelated Chest pain: secondary to rib injury: unrelated, unexpected GI: bloating: expected
|
|
Musculoskeletal and connective tissue disorders
costochondritis
|
0.00%
0/16 • Adverse events were collected throughout the study. 1 year 6 months total.
Intermittent sneezing, expected adverse event. Flatulence, expected adverse event General: "cold like symptoms", unrelated, expected given time of year Nasal irritation after nasal saline spray, unrelated, unexpected : GI: hemorrhoids: unexpected, unrelated Chest pain: secondary to rib injury: unrelated, unexpected GI: bloating: expected
|
0.00%
0/14 • Adverse events were collected throughout the study. 1 year 6 months total.
Intermittent sneezing, expected adverse event. Flatulence, expected adverse event General: "cold like symptoms", unrelated, expected given time of year Nasal irritation after nasal saline spray, unrelated, unexpected : GI: hemorrhoids: unexpected, unrelated Chest pain: secondary to rib injury: unrelated, unexpected GI: bloating: expected
|
0.00%
0/9 • Adverse events were collected throughout the study. 1 year 6 months total.
Intermittent sneezing, expected adverse event. Flatulence, expected adverse event General: "cold like symptoms", unrelated, expected given time of year Nasal irritation after nasal saline spray, unrelated, unexpected : GI: hemorrhoids: unexpected, unrelated Chest pain: secondary to rib injury: unrelated, unexpected GI: bloating: expected
|
12.5%
1/8 • Number of events 1 • Adverse events were collected throughout the study. 1 year 6 months total.
Intermittent sneezing, expected adverse event. Flatulence, expected adverse event General: "cold like symptoms", unrelated, expected given time of year Nasal irritation after nasal saline spray, unrelated, unexpected : GI: hemorrhoids: unexpected, unrelated Chest pain: secondary to rib injury: unrelated, unexpected GI: bloating: expected
|
|
Gastrointestinal disorders
gi complaint
|
6.2%
1/16 • Number of events 1 • Adverse events were collected throughout the study. 1 year 6 months total.
Intermittent sneezing, expected adverse event. Flatulence, expected adverse event General: "cold like symptoms", unrelated, expected given time of year Nasal irritation after nasal saline spray, unrelated, unexpected : GI: hemorrhoids: unexpected, unrelated Chest pain: secondary to rib injury: unrelated, unexpected GI: bloating: expected
|
0.00%
0/14 • Adverse events were collected throughout the study. 1 year 6 months total.
Intermittent sneezing, expected adverse event. Flatulence, expected adverse event General: "cold like symptoms", unrelated, expected given time of year Nasal irritation after nasal saline spray, unrelated, unexpected : GI: hemorrhoids: unexpected, unrelated Chest pain: secondary to rib injury: unrelated, unexpected GI: bloating: expected
|
0.00%
0/9 • Adverse events were collected throughout the study. 1 year 6 months total.
Intermittent sneezing, expected adverse event. Flatulence, expected adverse event General: "cold like symptoms", unrelated, expected given time of year Nasal irritation after nasal saline spray, unrelated, unexpected : GI: hemorrhoids: unexpected, unrelated Chest pain: secondary to rib injury: unrelated, unexpected GI: bloating: expected
|
0.00%
0/8 • Adverse events were collected throughout the study. 1 year 6 months total.
Intermittent sneezing, expected adverse event. Flatulence, expected adverse event General: "cold like symptoms", unrelated, expected given time of year Nasal irritation after nasal saline spray, unrelated, unexpected : GI: hemorrhoids: unexpected, unrelated Chest pain: secondary to rib injury: unrelated, unexpected GI: bloating: expected
|
|
General disorders
viral urti
|
6.2%
1/16 • Number of events 1 • Adverse events were collected throughout the study. 1 year 6 months total.
Intermittent sneezing, expected adverse event. Flatulence, expected adverse event General: "cold like symptoms", unrelated, expected given time of year Nasal irritation after nasal saline spray, unrelated, unexpected : GI: hemorrhoids: unexpected, unrelated Chest pain: secondary to rib injury: unrelated, unexpected GI: bloating: expected
|
0.00%
0/14 • Adverse events were collected throughout the study. 1 year 6 months total.
Intermittent sneezing, expected adverse event. Flatulence, expected adverse event General: "cold like symptoms", unrelated, expected given time of year Nasal irritation after nasal saline spray, unrelated, unexpected : GI: hemorrhoids: unexpected, unrelated Chest pain: secondary to rib injury: unrelated, unexpected GI: bloating: expected
|
0.00%
0/9 • Adverse events were collected throughout the study. 1 year 6 months total.
Intermittent sneezing, expected adverse event. Flatulence, expected adverse event General: "cold like symptoms", unrelated, expected given time of year Nasal irritation after nasal saline spray, unrelated, unexpected : GI: hemorrhoids: unexpected, unrelated Chest pain: secondary to rib injury: unrelated, unexpected GI: bloating: expected
|
0.00%
0/8 • Adverse events were collected throughout the study. 1 year 6 months total.
Intermittent sneezing, expected adverse event. Flatulence, expected adverse event General: "cold like symptoms", unrelated, expected given time of year Nasal irritation after nasal saline spray, unrelated, unexpected : GI: hemorrhoids: unexpected, unrelated Chest pain: secondary to rib injury: unrelated, unexpected GI: bloating: expected
|
|
General disorders
nasal irritation
|
0.00%
0/16 • Adverse events were collected throughout the study. 1 year 6 months total.
Intermittent sneezing, expected adverse event. Flatulence, expected adverse event General: "cold like symptoms", unrelated, expected given time of year Nasal irritation after nasal saline spray, unrelated, unexpected : GI: hemorrhoids: unexpected, unrelated Chest pain: secondary to rib injury: unrelated, unexpected GI: bloating: expected
|
7.1%
1/14 • Number of events 1 • Adverse events were collected throughout the study. 1 year 6 months total.
Intermittent sneezing, expected adverse event. Flatulence, expected adverse event General: "cold like symptoms", unrelated, expected given time of year Nasal irritation after nasal saline spray, unrelated, unexpected : GI: hemorrhoids: unexpected, unrelated Chest pain: secondary to rib injury: unrelated, unexpected GI: bloating: expected
|
0.00%
0/9 • Adverse events were collected throughout the study. 1 year 6 months total.
Intermittent sneezing, expected adverse event. Flatulence, expected adverse event General: "cold like symptoms", unrelated, expected given time of year Nasal irritation after nasal saline spray, unrelated, unexpected : GI: hemorrhoids: unexpected, unrelated Chest pain: secondary to rib injury: unrelated, unexpected GI: bloating: expected
|
0.00%
0/8 • Adverse events were collected throughout the study. 1 year 6 months total.
Intermittent sneezing, expected adverse event. Flatulence, expected adverse event General: "cold like symptoms", unrelated, expected given time of year Nasal irritation after nasal saline spray, unrelated, unexpected : GI: hemorrhoids: unexpected, unrelated Chest pain: secondary to rib injury: unrelated, unexpected GI: bloating: expected
|
|
Gastrointestinal disorders
abdominal bloating
|
6.2%
1/16 • Number of events 1 • Adverse events were collected throughout the study. 1 year 6 months total.
Intermittent sneezing, expected adverse event. Flatulence, expected adverse event General: "cold like symptoms", unrelated, expected given time of year Nasal irritation after nasal saline spray, unrelated, unexpected : GI: hemorrhoids: unexpected, unrelated Chest pain: secondary to rib injury: unrelated, unexpected GI: bloating: expected
|
0.00%
0/14 • Adverse events were collected throughout the study. 1 year 6 months total.
Intermittent sneezing, expected adverse event. Flatulence, expected adverse event General: "cold like symptoms", unrelated, expected given time of year Nasal irritation after nasal saline spray, unrelated, unexpected : GI: hemorrhoids: unexpected, unrelated Chest pain: secondary to rib injury: unrelated, unexpected GI: bloating: expected
|
0.00%
0/9 • Adverse events were collected throughout the study. 1 year 6 months total.
Intermittent sneezing, expected adverse event. Flatulence, expected adverse event General: "cold like symptoms", unrelated, expected given time of year Nasal irritation after nasal saline spray, unrelated, unexpected : GI: hemorrhoids: unexpected, unrelated Chest pain: secondary to rib injury: unrelated, unexpected GI: bloating: expected
|
0.00%
0/8 • Adverse events were collected throughout the study. 1 year 6 months total.
Intermittent sneezing, expected adverse event. Flatulence, expected adverse event General: "cold like symptoms", unrelated, expected given time of year Nasal irritation after nasal saline spray, unrelated, unexpected : GI: hemorrhoids: unexpected, unrelated Chest pain: secondary to rib injury: unrelated, unexpected GI: bloating: expected
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/16 • Adverse events were collected throughout the study. 1 year 6 months total.
Intermittent sneezing, expected adverse event. Flatulence, expected adverse event General: "cold like symptoms", unrelated, expected given time of year Nasal irritation after nasal saline spray, unrelated, unexpected : GI: hemorrhoids: unexpected, unrelated Chest pain: secondary to rib injury: unrelated, unexpected GI: bloating: expected
|
7.1%
1/14 • Number of events 1 • Adverse events were collected throughout the study. 1 year 6 months total.
Intermittent sneezing, expected adverse event. Flatulence, expected adverse event General: "cold like symptoms", unrelated, expected given time of year Nasal irritation after nasal saline spray, unrelated, unexpected : GI: hemorrhoids: unexpected, unrelated Chest pain: secondary to rib injury: unrelated, unexpected GI: bloating: expected
|
0.00%
0/9 • Adverse events were collected throughout the study. 1 year 6 months total.
Intermittent sneezing, expected adverse event. Flatulence, expected adverse event General: "cold like symptoms", unrelated, expected given time of year Nasal irritation after nasal saline spray, unrelated, unexpected : GI: hemorrhoids: unexpected, unrelated Chest pain: secondary to rib injury: unrelated, unexpected GI: bloating: expected
|
0.00%
0/8 • Adverse events were collected throughout the study. 1 year 6 months total.
Intermittent sneezing, expected adverse event. Flatulence, expected adverse event General: "cold like symptoms", unrelated, expected given time of year Nasal irritation after nasal saline spray, unrelated, unexpected : GI: hemorrhoids: unexpected, unrelated Chest pain: secondary to rib injury: unrelated, unexpected GI: bloating: expected
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/16 • Adverse events were collected throughout the study. 1 year 6 months total.
Intermittent sneezing, expected adverse event. Flatulence, expected adverse event General: "cold like symptoms", unrelated, expected given time of year Nasal irritation after nasal saline spray, unrelated, unexpected : GI: hemorrhoids: unexpected, unrelated Chest pain: secondary to rib injury: unrelated, unexpected GI: bloating: expected
|
7.1%
1/14 • Number of events 1 • Adverse events were collected throughout the study. 1 year 6 months total.
Intermittent sneezing, expected adverse event. Flatulence, expected adverse event General: "cold like symptoms", unrelated, expected given time of year Nasal irritation after nasal saline spray, unrelated, unexpected : GI: hemorrhoids: unexpected, unrelated Chest pain: secondary to rib injury: unrelated, unexpected GI: bloating: expected
|
0.00%
0/9 • Adverse events were collected throughout the study. 1 year 6 months total.
Intermittent sneezing, expected adverse event. Flatulence, expected adverse event General: "cold like symptoms", unrelated, expected given time of year Nasal irritation after nasal saline spray, unrelated, unexpected : GI: hemorrhoids: unexpected, unrelated Chest pain: secondary to rib injury: unrelated, unexpected GI: bloating: expected
|
0.00%
0/8 • Adverse events were collected throughout the study. 1 year 6 months total.
Intermittent sneezing, expected adverse event. Flatulence, expected adverse event General: "cold like symptoms", unrelated, expected given time of year Nasal irritation after nasal saline spray, unrelated, unexpected : GI: hemorrhoids: unexpected, unrelated Chest pain: secondary to rib injury: unrelated, unexpected GI: bloating: expected
|
Additional Information
Joseph Yusin Chief division Allergy Immunology
VA Greater Los Angeles Healthcare System
Phone: 3104783711
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place