Phase 2
N=47
Effects of Broccoli Sprout Extract on Allergy Rhinitis
Rhinitis,Allergic
Bottom Line
View on ClinicalTrials.gov: NCT02885025 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: Total Nasal Symptom Score (TNSS) Change From Baseline to 3 Weeks of Randomly Assigned Treatment — -.5277; -.5484; -.8359; -.181 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Broccoli Sprout Extract (Dietary_supplement); fluticasone nasal (Drug); broccoli sprout extract placebo (Dietary_supplement); normal saline nasal spray (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Nasal Symptom Score (TNSS) Change From Baseline to 3 Weeks of Randomly Assigned Treatment |
-.5277; -.5484; -.8359; -.181 | — |
| PRIMARY Peak Nasal Inspiratory Flow (PNIF) Change From Baseline to 3 Weeks of Randomly Assigned Treatment |
.3362; .1213; .0636; -.0538 | — |
| SECONDARY Interleukin 5 (IL5) |
-.5285; -.3213; -.1082; -.3755 | — |
| SECONDARY Interleukin 4 (IL4) |
-.5655; -.1076; -.3682; -.3695 | — |
| SECONDARY Interleukin 6 (IL6) |
-1.0868; -.0519; -.2719; .3567 | — |
| SECONDARY Interleukin 8 (IL8) |
-.7626; -.047; -.1013; .0472 | — |
| SECONDARY Interleukin 13 (IL13) |
-1.0822; -.2985; .1577; -.0459 | — |
| SECONDARY Interleukin 1 Beta (IL1b) |
-.4058; .0183; -.2382; .0713 | — |
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 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.
Eligibility Criteria
Inclusion Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT02885025). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.