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Effects of Broccoli Sprout Extract on Allergy Rhinitis

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: NCT02885025
Recruitment Status : Completed
First Posted : August 31, 2016
Results First Posted : June 19, 2020
Last Update Posted : June 19, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Rhinitis,Allergic
Interventions Dietary Supplement: Broccoli Sprout Extract
Drug: fluticasone nasal
Dietary Supplement: broccoli sprout extract placebo
Drug: normal saline nasal spray
Enrollment 47
Recruitment Details Patients were recruited from the VA Greater Los Angeles Healthcare System Allergy Immunology Clinic
Pre-assignment Details  
Arm/Group Title BSE + Nasal Fluticasone BSE + Normal Saline Nasal Spray Placebo Pill + Nasal Fluticasone Placebo Pill + Normal Saline Nasal Spray
Hide Arm/Group Description

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.

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

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.

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

Period Title: Overall Study
Started 16 14 9 8
Completed 16 12 9 8
Not Completed 0 2 0 0
Arm/Group Title BSE + Nasal Fluticasone BSE + Normal Saline Nasal Spray Placebo Pill + Nasal Fluticasone Placebo Pill + Normal Saline Nasal Spray Total
Hide Arm/Group Description

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.

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

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.

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 of all reporting groups
Overall Number of Baseline Participants 16 14 9 8 47
Hide Baseline Analysis Population Description
A total of 47 subjects had a positive reaction to the up dose grass allergen challenge that began with 75 subjects.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 14 participants 9 participants 8 participants 47 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
  93.8%
12
  85.7%
5
  55.6%
7
  87.5%
39
  83.0%
>=65 years
1
   6.3%
2
  14.3%
4
  44.4%
1
  12.5%
8
  17.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 14 participants 9 participants 8 participants 47 participants
Female
4
  25.0%
2
  14.3%
3
  33.3%
3
  37.5%
12
  25.5%
Male
12
  75.0%
12
  85.7%
6
  66.7%
5
  62.5%
35
  74.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 14 participants 9 participants 8 participants 47 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
3
  18.8%
1
   7.1%
1
  11.1%
0
   0.0%
5
  10.6%
Native Hawaiian or Other Pacific Islander
2
  12.5%
0
   0.0%
0
   0.0%
1
  12.5%
3
   6.4%
Black or African American
4
  25.0%
5
  35.7%
4
  44.4%
4
  50.0%
17
  36.2%
White
7
  43.8%
8
  57.1%
3
  33.3%
3
  37.5%
21
  44.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
  11.1%
0
   0.0%
1
   2.1%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 16 participants 14 participants 9 participants 8 participants 47 participants
16
 100.0%
14
 100.0%
9
 100.0%
8
 100.0%
47
 100.0%
PNIF   [1] 
Mean (Standard Deviation)
Unit of measure:  L/min
Number Analyzed 16 participants 14 participants 9 participants 8 participants 47 participants
105  (21.2) 120  (14.1) 172.5  (31.8) 170  (28.3) 155  (49.5)
[1]
Measure Description: Peak Nasal Inspiratory Flow: Range is 0 - 400 L/min. Note that increase in value is consistent with decreased nasal resistance consistent with an improvement.
1.Primary Outcome
Title Total Nasal Symptom Score (TNSS) Change From Baseline to 3 Weeks of Randomly Assigned Treatment
Hide Description 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.
Time Frame measures at various points following challenge at baseline and 21 days
Hide Outcome Measure Data
Hide Analysis Population Description
intent to treat population (all participants assigned to 1 of the 4 groups above).
Arm/Group Title BSE + Nasal Fluticasone BSE + Normal Saline Nasal Spray Placebo Pill + Nasal Fluticasone Placebo Pill + Normal Saline Nasal Spray
Hide Arm/Group Description:
patients received combination of broccoli sprout extract tablet and nasal fluticasone for a total of 3 weeks
Patients received broccoli sprout extract tablets and nasal saline spray for 3 weeks.
Patients received placebo tablet and nasal fluticasone for 3 weeks.
Patients received placebo tablet and normal saline nasal spray for 3 weeks
Overall Number of Participants Analyzed 16 12 9 8
Mean (Standard Deviation)
Unit of Measure: score on a scale
-.5277  (0.1048) -.5484  (.0014) -.8359  (0.3903) -.181  (.0846)
2.Primary Outcome
Title Peak Nasal Inspiratory Flow (PNIF) Change From Baseline to 3 Weeks of Randomly Assigned Treatment
Hide Description 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).
Time Frame 21 days (from randomization to completion)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BSE + Nasal Fluticasone BSE + Normal Saline Nasal Spray Placebo Pill + Nasal Fluticasone Placebo Pill + Normal Saline Nasal Spray
Hide Arm/Group Description:

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.

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

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.

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 Number of Participants Analyzed 16 12 9 8
Mean (Standard Deviation)
Unit of Measure: L/min
.3362  (.0026) .1213  (.0607) .0636  (.0485) -.0538  (.0453)
3.Secondary Outcome
Title Interleukin 5 (IL5)
Hide Description 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.
Time Frame 21 days (from randomization to completion)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BSE + Nasal Fluticasone BSE + Normal Saline Nasal Spray Placebo Pill + Nasal Fluticasone Placebo Pill + Normal Saline Nasal Spray
Hide Arm/Group Description:
patients received combination of broccoli sprout extract tablet and nasal fluticasone for a total of 3 weeks
Patients received broccoli sprout extract tablets and nasal saline spray for 3 weeks.
Patients received placebo tablet and nasal fluticasone for 3 weeks.
Patients received placebo tablet and normal saline nasal spray for 3 weeks
Overall Number of Participants Analyzed 16 12 9 8
Mean (Standard Deviation)
Unit of Measure: log(pg/ml)
-.5285  (.2236) -.3213  (.2005) -.1082  (.0083) -.3755  (0.1866)
4.Secondary Outcome
Title Interleukin 4 (IL4)
Hide Description 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.
Time Frame 21 days (from randomization to completion)
Hide Outcome Measure Data
Hide Analysis Population Description
Patient diagnosed with grass induced allergic rhinitis were randomized into 1 of 4 groups.
Arm/Group Title BSE + Nasal Fluticasone BSE + Normal Saline Nasal Spray Placebo Pill + Nasal Fluticasone Placebo Pill + Normal Saline Nasal Spray
Hide Arm/Group Description:

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.

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

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.

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 Number of Participants Analyzed 16 12 9 8
Mean (Standard Deviation)
Unit of Measure: log(pg/ml)
-.5655  (0.4738) -.1076  (.0228) -.3682  (.0294) -.3695  (.233)
5.Secondary Outcome
Title Interleukin 6 (IL6)
Hide Description 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.
Time Frame 21 days (from randomization to completion)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BSE + Nasal Fluticasone BSE + Normal Saline Nasal Spray Placebo Pill + Nasal Fluticasone Placebo Pill + Normal Saline Nasal Spray
Hide Arm/Group Description:
patients received combination of broccoli sprout extract tablet and nasal fluticasone for a total of 3 weeks
Patients received broccoli sprout extract tablets and nasal saline spray for 3 weeks.
Patients received placebo tablet and nasal fluticasone for 3 weeks.
Patients received placebo tablet and normal saline nasal spray for 3 weeks
Overall Number of Participants Analyzed 16 12 9 8
Mean (Standard Deviation)
Unit of Measure: log(pg/ml)
-1.0868  (.2903) -.0519  (.2437) -.2719  (1.6894) .3567  (.2826)
6.Secondary Outcome
Title Interleukin 8 (IL8)
Hide Description 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.
Time Frame 21 days (from randomization to completion)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BSE + Nasal Fluticasone BSE + Normal Saline Nasal Spray Placebo Pill + Nasal Fluticasone Placebo Pill + Normal Saline Nasal Spray
Hide Arm/Group Description:
patients received combination of broccoli sprout extract tablet and nasal fluticasone for a total of 3 weeks
Patients received broccoli sprout extract tablets and nasal saline spray for 3 weeks.
Patients received placebo tablet and nasal fluticasone for 3 weeks.
Patients received placebo tablet and normal saline nasal spray for 3 weeks
Overall Number of Participants Analyzed 16 12 9 8
Mean (Standard Deviation)
Unit of Measure: pg/ml log transformation
-.7626  (.0168) -.047  (.0033) -.1013  (.2629) .0472  (.1748)
7.Secondary Outcome
Title Interleukin 13 (IL13)
Hide Description 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.
Time Frame 21 days (from randomization to completion)
Hide Outcome Measure Data
Hide Analysis Population Description
Patient diagnosed with grass induced allergic rhinitis were randomized into 1 of 4 groups.
Arm/Group Title BSE + Nasal Fluticasone BSE + Normal Saline Nasal Spray Placebo Pill + Nasal Fluticasone Placebo Pill + Normal Saline Nasal Spray
Hide Arm/Group Description:
patients received combination of broccoli sprout extract tablet and nasal fluticasone for a total of 3 weeks
Patients received broccoli sprout extract tablets and nasal saline spray for 3 weeks.
Patients received placebo tablet and nasal fluticasone for 3 weeks.
Patients received placebo tablet and normal saline nasal spray for 3 weeks
Overall Number of Participants Analyzed 16 12 9 8
Mean (Standard Deviation)
Unit of Measure: log(pg/ml)
-1.0822  (.2568) -.2985  (.0466) .1577  (.1042) -.0459  (.3745)
8.Secondary Outcome
Title Interleukin 1 Beta (IL1b)
Hide Description 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.
Time Frame 21 days (from randomization to completion)
Hide Outcome Measure Data
Hide Analysis Population Description
Patient diagnosed with grass induced allergic rhinitis were randomized into 1 of 4 groups
Arm/Group Title BSE + Nasal Fluticasone BSE + Normal Saline Nasal Spray Placebo Pill + Nasal Fluticasone Placebo Pill + Normal Saline Nasal Spray
Hide Arm/Group Description:
patients received combination of broccoli sprout extract tablet and nasal fluticasone for a total of 3 weeks
Patients received broccoli sprout extract tablets and nasal saline spray for 3 weeks.
Patients received placebo tablet and nasal fluticasone for 3 weeks.
Patients received placebo tablet and normal saline nasal spray for 3 weeks
Overall Number of Participants Analyzed 16 12 9 8
Mean (Standard Deviation)
Unit of Measure: pg/ml with log transformation
-.4058  (.2563) .0183  (.037) -.2382  (.3013) .0713  (.1139)
Time Frame Adverse events were collected throughout the study. 1 year 6 months total.
Adverse Event Reporting Description

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

 
Arm/Group Title BSE + Nasal Fluticasone BSE + Normal Saline Nasal Spray Placebo Pill + Nasal Fluticasone Placebo Pill + Normal Saline Nasal Spray
Hide Arm/Group Description

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.

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

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.

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

All-Cause Mortality
BSE + Nasal Fluticasone BSE + Normal Saline Nasal Spray Placebo Pill + Nasal Fluticasone Placebo Pill + Normal Saline Nasal Spray
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)      0/14 (0.00%)      0/9 (0.00%)      0/8 (0.00%)    
Hide Serious Adverse Events
BSE + Nasal Fluticasone BSE + Normal Saline Nasal Spray Placebo Pill + Nasal Fluticasone Placebo Pill + Normal Saline Nasal Spray
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/16 (0.00%)      0/14 (0.00%)      0/9 (0.00%)      0/8 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
BSE + Nasal Fluticasone BSE + Normal Saline Nasal Spray Placebo Pill + Nasal Fluticasone Placebo Pill + Normal Saline Nasal Spray
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/16 (18.75%)      4/14 (28.57%)      0/9 (0.00%)      2/8 (25.00%)    
Gastrointestinal disorders         
gi complaints * [1]  0/16 (0.00%)  0/14 (0.00%)  0/9 (0.00%)  1/8 (12.50%)  1
gi complaint * [2]  1/16 (6.25%)  1 0/14 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
abdominal bloating * [3]  1/16 (6.25%)  1 0/14 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
diarrhea * [4]  0/16 (0.00%)  1/14 (7.14%)  1 0/9 (0.00%)  0/8 (0.00%) 
nausea * [5]  0/16 (0.00%)  1/14 (7.14%)  1 0/9 (0.00%)  0/8 (0.00%) 
General disorders         
nasal symptom * 1 [6]  0/16 (0.00%)  0 1/14 (7.14%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0
viral urti * [7]  1/16 (6.25%)  1 0/14 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
nasal irritation * [8]  0/16 (0.00%)  1/14 (7.14%)  1 0/9 (0.00%)  0/8 (0.00%) 
Musculoskeletal and connective tissue disorders         
costochondritis * [9]  0/16 (0.00%)  0 0/14 (0.00%)  0/9 (0.00%)  1/8 (12.50%)  1
1
Term from vocabulary, sneezing
*
Indicates events were collected by non-systematic assessment
[1]
Flatulence
[2]
hemorrhoids
[3]
abdominal bloating
[4]
diarrhea
[5]
nausea
[6]
sneezing
[7]
viral upper respiratory track infection (nasal congestion, sneezing and rhinorrhea)
[8]
nasal irritation
[9]
patient went to ER during study for check pain that was reproducible and diagnosed with costochondritis
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Joseph Yusin Chief division Allergy Immunology
Organization: VA Greater Los Angeles Healthcare System
Phone: 3104783711 ext 40230
EMail: joseph.yusin2@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02885025    
Other Study ID Numbers: CLNB-03-15F
First Submitted: August 23, 2016
First Posted: August 31, 2016
Results First Submitted: April 7, 2020
Results First Posted: June 19, 2020
Last Update Posted: June 19, 2020