Effects of Broccoli Sprout Extract on Allergy Rhinitis
Condition: Rhinitis,Allergic
MeSH terms: Rhinitis; Rhinitis, Allergic
Intervention: Broccoli Sprout Extract; fluticasone nasal; broccoli sprout extract placebo; normal saline nasal spray
Intervention description: Broccoli Sprout Extract contains the antioxidant Sulforaphane which is the active ingredient being studies.; fluticasone is a nasal steroid that is currently approved for treatment of allergic rhinitis.; a tablet similar to the actual broccoli sprout extract though without BSE.; normal saline to replace nasal fluticasone in specific arms of the study
Intervention MeSH terms: Fluticasone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: hypersensitivity; antioxidants

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

          1. Females and males 18 years or older.

          2. History consistent with seasonal allergic rhinitis consistent with grass allergy
             (symptoms during summer months, June through August, for at least two consecutive
             seasons).

          3. Not currently taking any medications for allergic rhinitis.

          4. Provide written informed consent.

          5. Willing and able to comply with all aspects of the protocol.

        Exclusion Criteria:

          1. 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.

          2. History of anaphylaxis to environmental allergens or an unknown trigger.

          3. History of broccoli allergy

          4. Recent upper respiratory infection (less than 4 weeks prior to study) or other active
             Infection.

          5. Active smoker

          6. Currently receiving allergy immunotherapy.

          7. History of rhinitis exacerbation within the past 2 weeks.

          8. Use of non-selective Beta-Blocker.

          9. Inability to give written informed consent.

         10. 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.

         11. Pregnancy

         12. Perennial rhinitis

         13. Uncontrolled asthma

         14. Forced Expiratory Volume in 1 second <70% predicted at screening.