Rhinitis,AllergicPhase 2NCT02885025
Effects of Broccoli Sprout Extract on Allergy Rhinitis
A Phase 2 study testing Broccoli Sprout Extract, fluticasone nasal and normal saline nasal spray in people with Rhinitis,Allergic, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Allergic rhinitis is a common illness suffered among US Veterans. There are medications that help relieve allergy symptoms, including nasal steroid sprays and antihistamines. Some patients have increase symptoms with exposure to their trigger, such as a grasses when combined with pollution due to oxidative stress from… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rhinitis,Allergic
- What is being tested?
- Broccoli Sprout Extract, fluticasone nasal and normal saline nasal spray
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2016to 12 Mar 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Females and males 18 years or older.
- History consistent with seasonal allergic rhinitis consistent with grass allergy (symptoms during summer months, June through August, for at least two consecutive seasons).
- Not currently taking any medications for allergic rhinitis.
- Provide written informed consent.
- Willing and able to comply with all aspects of the protocol.
Who cannot join
- The subject has any uncontrolled or serious disease, or any medical or surgical or condition that in the opinion of the investigator(s) could affect the subject's safety and/or interfere with the study assessments.
- History of anaphylaxis to environmental allergens or an unknown trigger.
- History of broccoli allergy
- Recent upper respiratory infection (less than 4 weeks prior to study) or other active Infection.
- Active smoker
- Currently receiving allergy immunotherapy.
Show all 14Show fewer
- History of rhinitis exacerbation within the past 2 weeks.
- Use of non-selective Beta-Blocker.
- Inability to give written informed consent.
- History or evidence of non-stable cognitive capacity within less than 1 year (i.e. Alzheimer's disease, dementia, bipolar disorder) that in the opinion of the investigator(s) could affect the subject's safety and/or interfere with the study assessments.
- Pregnancy
- Perennial rhinitis
- Uncontrolled asthma
- Forced Expiratory Volume in 1 second <70% predicted at screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073
About this study
Official title: Effects of Broccoli Sprout Extract on Allergic Rhinitis
Allergic rhinitis is a common illness suffered among US Veterans. There are medications that help relieve allergy symptoms, including nasal steroid sprays and antihistamines. Some patients have increase symptoms with exposure to their trigger, such as a grasses when combined with pollution due to oxidative stress from pollution. In this study, patients with allergic rhinitis to grass will be given broccoli sprout extract that contains an antioxidant sulforaphane do see if there is beneficial effect in these patients.
Read the detailed description
Allergic rhinitis is a common illness suffered among US Veterans. Despite the availability of medications, many patients fail to get adequate control of symptoms especially in high pollutant areas. Southern California air pollutants, like diesel exhaust particles may act as adjuvants to allergens leading to an exaggerated allergic response in certain individuals. These individuals may lack adequate Glutathione transferase activity; necessary to protect cells against pollutant induced oxidative stress. Sulforaphane has been shown to protect against oxidative stress. The investigators hypothesize consumption of foods containing high levels of sulforaphane are beneficial to US Veterans with GST deficiencies suffering from allergic rhinitis. In the investigators' preliminary data, the investigators discovered administration of broccoli sprout extract rich in sulforaphane leads to diminished nasal inflammatory reaction brought on by diesel exhaust particles though did not have sufficient patient numbers to prove an association with GST deficiency. The investigators propose a 3 week randomized clinical trial comparing broccoli sprout extract consumption with nasal corticosteroid administration after subjects with allergic rhinitis undergo a Timothy, Bermuda or Johnson grass nasal challenge. In Aims 1 and 2, the investigators will compare clinical (nasal symptom scores and peak nasal inspiratory flows) and laboratory (inflammatory cytokines, eosinophil cationic protein, tryptase) measurements between four groups: nasal corticosteroid, broccoli sprout extract, nasal corticosteroid plus broccoli sprout extract, and placebo. Aim 3 focuses on exploratory genetic analysis of the 3 glutathione S-transferase (GST) genes to determine if correlations exist between the inability to produce GST enzyme and the response to broccoli sprout extract. At the conclusion of this study, the investigators will gain further knowledge of which patients benefit from anti-oxidant nutritional supplementation in treating allergic rhinitis.
- Conditions
- Rhinitis,Allergic
- Being tested
- Broccoli Sprout Extract, fluticasone nasal, broccoli sprout extract placebo, normal saline nasal spray
- Keywords
- hypersensitivity, antioxidants
- Medical subject headings
- Rhinitis, Allergic, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Broccoli Sprout ExtractDietary supplement
Broccoli Sprout Extract contains the antioxidant Sulforaphane which is the active ingredient being studies.
fluticasone nasalDrug
fluticasone is a nasal steroid that is currently approved for treatment of allergic rhinitis.
broccoli sprout extract placeboDietary supplement
a tablet similar to the actual broccoli sprout extract though without BSE.
normal saline nasal sprayDrug
normal saline to replace nasal fluticasone in specific arms of the study
| Study group | Role | What they receive |
|---|---|---|
| BSE + Nasal Fluticasone | Active comparator | subjects will be randomized into 1 of 4 arms:
1. Broccoli Sprout Extract + Nasal Fluticasone
2. Broccoli Sprout Extract + normal saline nasal spray
3. Placebo Pill + Nasal Fluticasone
4. Placebo Pill + normal saline nasal spray Receives: Dietary Supplement: Broccoli Sprout Extract; Drug: fluticasone nasal |
| Broccoli Sprout Extract + normal saline nasal spray | Active comparator | subjects will be randomized into 1 of 4 arms:
1. Broccoli Sprout Extract + Nasal Fluticasone
2. Broccoli Sprout Extract + normal saline nasal spray
3. Placebo Pill + Nasal Fluticasone
4. Placebo Pill + normal saline nasal spray Receives: Dietary Supplement: Broccoli Sprout Extract; Drug: normal saline nasal spray |
| Placebo Pill + Nasal Fluticasone | Active comparator | subjects will be randomized into 1 of 4 arms:
1. Broccoli Sprout Extract + Nasal Fluticasone 2 Broccoli Sprout Extract + normal saline nasal spray 3. Placebo Pill + Nasal Fluticasone 4. Placebo Pill + normal saline nasal spray Receives: Drug: fluticasone nasal; Dietary Supplement: broccoli sprout extract placebo |
| Placebo Pill + normal saline nasal spray | Placebo comparator | subjects will be randomized into 1 of 4 arms:
1. Broccoli Sprout Extract + Nasal Fluticasone
2. Broccoli Sprout Extract + normal saline nasal spray
3. Placebo Pill + Nasal Fluticasone
4. Placebo Pill + normal saline nasal spray Receives: Dietary Supplement: broccoli sprout extract placebo; Drug: normal saline nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Nasal Symptom Score (TNSS) Change From Baseline to 3 Weeks of Randomly Assigned Treatment
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.
Measured: measures at various points following challenge at baseline and 21 days
Peak Nasal Inspiratory Flow (PNIF) Change From Baseline to 3 Weeks of Randomly Assigned Treatment
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).
Measured: 21 days (from randomization to completion)
Secondary outcomes (6)
Interleukin 5 (IL5)
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.
Measured: 21 days (from randomization to completion)
Interleukin 4 (IL4)
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.
Measured: 21 days (from randomization to completion)
Interleukin 6 (IL6)
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.
Measured: 21 days (from randomization to completion)
Interleukin 8 (IL8)
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.
Measured: 21 days (from randomization to completion)
Interleukin 13 (IL13)
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.
Measured: 21 days (from randomization to completion)
Interleukin 1 Beta (IL1b)
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.
Measured: 21 days (from randomization to completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study start1 Oct 2016
- Primary completion12 Mar 2019
- Study completion12 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rhinitis,AllergicStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Zhaoping Li, MD, Principal investigator, VA Greater Los Angeles Healthcare System, West Los Angeles, CAJoseph Stephen Yusin, MD, Principal investigator, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02885025
- Sponsor's protocol ID
- CLNB-03-15F
- Status last verified
- May 2020
- First submitted
- 23 Aug 2016
- Last updated
- 19 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Broccoli Sprout Extract on Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT02885025
- Acronym / sponsor ID
- CLNB-03-15F
- Conditions
- Rhinitis,Allergic
- Keywords
- hypersensitivity, antioxidants
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 12 Mar 2019 (actual)
- Study completion
- 12 Mar 2019 (actual)
- First posted
- 31 Aug 2016 (estimated)
- Results
- Posted 19 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Allergic rhinitis is a common illness suffered among US Veterans. There are medications that help relieve allergy symptoms, including nasal steroid sprays and antihistamines. Some patients have increase symptoms with exposure to their trigger, such as a grasses when combined with pollution due to oxidative stress from pollution. In this study, patients with allergic rhinitis to grass will be given broccoli sprout extract that contains an antioxidant sulforaphane do see if there is beneficial effect in these patients.
Detailed description
Allergic rhinitis is a common illness suffered among US Veterans. Despite the availability of medications, many patients fail to get adequate control of symptoms especially in high pollutant areas. Southern California air pollutants, like diesel exhaust particles may act as adjuvants to allergens leading to an exaggerated allergic response in certain individuals. These individuals may lack adequate Glutathione transferase activity; necessary to protect cells against pollutant induced oxidative stress. Sulforaphane has been shown to protect against oxidative stress. The investigators hypothesize consumption of foods containing high levels of sulforaphane are beneficial to US Veterans with GST deficiencies suffering from allergic rhinitis. In the investigators' preliminary data, the investigators discovered administration of broccoli sprout extract rich in sulforaphane leads to diminished nasal inflammatory reaction brought on by diesel exhaust particles though did not have sufficient patient numbers to prove an association with GST deficiency. The investigators propose a 3 week randomized clinical trial comparing broccoli sprout extract consumption with nasal corticosteroid administration after subjects with allergic rhinitis undergo a Timothy, Bermuda or Johnson grass nasal challenge. In Aims 1 and 2, the investigators will compare clinical (nasal symptom scores and peak nasal inspiratory flows) and laboratory (inflammatory cytokines, eosinophil cationic protein, tryptase) measurements between four groups: nasal corticosteroid, broccoli sprout extract, nasal corticosteroid plus broccoli sprout extract, and placebo. Aim 3 focuses on exploratory genetic analysis of the 3 glutathione S-transferase (GST) genes to determine if correlations exist between the inability to produce GST enzyme and the response to broccoli sprout extract. At the conclusion of this study, the investigators will gain further knowledge of which patients benefit from anti-oxidant nutritional supplementation in treating allergic rhinitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BSE + Nasal Fluticasone | Active comparator | Dietary Supplement: Broccoli Sprout Extract, Drug: fluticasone nasalsubjects will be randomized into 1 of 4 arms: 1. Broccoli Sprout Extract + Nasal Fluticasone 2. Broccoli Sprout Extract + normal saline nasal spray 3. Placebo Pill + Nasal Fluticasone 4. Placebo Pill + normal saline nasal spray |
| Broccoli Sprout Extract + normal saline nasal spray | Active comparator | Dietary Supplement: Broccoli Sprout Extract, Drug: normal saline nasal spraysubjects will be randomized into 1 of 4 arms: 1. Broccoli Sprout Extract + Nasal Fluticasone 2. Broccoli Sprout Extract + normal saline nasal spray 3. Placebo Pill + Nasal Fluticasone 4. Placebo Pill + normal saline nasal spray |
| Placebo Pill + Nasal Fluticasone | Active comparator | Drug: fluticasone nasal, Dietary Supplement: broccoli sprout extract placebosubjects will be randomized into 1 of 4 arms: 1. Broccoli Sprout Extract + Nasal Fluticasone 2 Broccoli Sprout Extract + normal saline nasal spray 3. Placebo Pill + Nasal Fluticasone 4. Placebo Pill + normal saline nasal spray |
| Placebo Pill + normal saline nasal spray | Placebo comparator | Dietary Supplement: broccoli sprout extract placebo, Drug: normal saline nasal spraysubjects will be randomized into 1 of 4 arms: 1. Broccoli Sprout Extract + Nasal Fluticasone 2. Broccoli Sprout Extract + normal saline nasal spray 3. Placebo Pill + Nasal Fluticasone 4. Placebo Pill + normal saline nasal spray |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Females and males 18 years or older.
- History consistent with seasonal allergic rhinitis consistent with grass allergy (symptoms during summer months, June through August, for at least two consecutive seasons).
- Not currently taking any medications for allergic rhinitis.
- Provide written informed consent.
- Willing and able to comply with all aspects of the protocol.
Key exclusion criteria (14 listed)
- The subject has any uncontrolled or serious disease, or any medical or surgical or condition that in the opinion of the investigator(s) could affect the subject's safety and/or interfere with the study assessments.
- History of anaphylaxis to environmental allergens or an unknown trigger.
- History of broccoli allergy
- Recent upper respiratory infection (less than 4 weeks prior to study) or other active Infection.
- Active smoker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Broccoli Sprout ExtractBroccoli Sprout Extract contains the antioxidant Sulforaphane which is the active ingredient being studies. | Dietary supplement | BSE + Nasal Fluticasone, Broccoli Sprout Extract + normal saline nasal spray |
| fluticasone nasalfluticasone is a nasal steroid that is currently approved for treatment of allergic rhinitis. | Drug | BSE + Nasal Fluticasone, Placebo Pill + Nasal Fluticasone |
| broccoli sprout extract placeboa tablet similar to the actual broccoli sprout extract though without BSE. | Dietary supplement | Placebo Pill + Nasal Fluticasone, Placebo Pill + normal saline nasal spray |
| normal saline nasal spraynormal saline to replace nasal fluticasone in specific arms of the study | Drug | Broccoli Sprout Extract + normal saline nasal spray, Placebo Pill + normal saline nasal spray |
Primary outcome
Total Nasal Symptom Score (TNSS) Change From Baseline to 3 Weeks of Randomly Assigned Treatment
Time frame: measures at various points following challenge at baseline and 21 days
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.
Peak Nasal Inspiratory Flow (PNIF) Change From Baseline to 3 Weeks of Randomly Assigned Treatment
Time frame: 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).
6 secondary outcomes
Interleukin 5 (IL5)
Time frame: 21 days (from randomization to completion)
Interleukin 4 (IL4)
Time frame: 21 days (from randomization to completion)
Interleukin 6 (IL6)
Time frame: 21 days (from randomization to completion)
Interleukin 8 (IL8)
Time frame: 21 days (from randomization to completion)
Interleukin 13 (IL13)
Time frame: 21 days (from randomization to completion)
Interleukin 1 Beta (IL1b)
Time frame: 21 days (from randomization to completion)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhaoping Li, MD principal investigator
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Joseph Stephen Yusin, MD principal investigator
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Broccoli Sprout Extract, fluticasone nasal and normal saline nasal spray in people with Rhinitis,Allergic, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Nasal Symptom Score (TNSS) Change From Baseline to 3 Weeks of Randomly Assigned Treatment (time frame: measures at various points following challenge at baseline and 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2020.