Broccoli Sprout Extracts Trial to See if NRF2 is Enhanced by Sulforaphane Treatment in Patients With COPD
Condition: COPD
Intervention: Sulforaphane 25; Sulforaphane 150; Placebo
Intervention description: 25 micromoles (4.4 mg) sulforaphane daily by mouth; 150 micromoles (26.6 mg) sulforaphane daily by mouth; Microcrystalline cellulose once daily by mouth
Intervention MeSH terms: Sulforaphane
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 89.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD; Nrf2; Sulforaphane

Summary:

      Evidence from investigators' group has shown that chronic obstructive pulmonary disease
      (COPD) patients have impairment of antioxidant defenses which are caused by a defect in
      activity of Nrf2. This trial focuses on sulforaphane, a derivative of cruciferous vegetables,
      which is a potent stimulator of Nrf2 activity. The investigators want to investigate whether
      ingestion of sulforaphane by COPD patients will increase Nrf2 activity and expression of
      downstream antioxidants. Accordingly, the investigators are conducting a placebo-controlled
      randomized proof of principle trial of two oral doses of sulforaphane, 25 and 150 micromoles,
      for 4 weeks in 90 COPD patients. The investigators' goal is to establish a safe and tolerable
      dose of sulforaphane that effects in vivo antioxidants via Nrf2, then the investigators will
      have a novel candidate treatment for longer-term efficacy trials.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 40 years or greater, either sex

          -  10 or more pack-years smoking history

          -  Physician diagnosed COPD

          -  Post bronchodilator Forced expiratory volume in 1 second (FEV1)/ forced expiratory
             vital capacity (FVC) ratio < 0.70

          -  FEV1 40-80 % predicted

          -  Willingness to ingest no more than 1 serving of cruciferous vegetables per week during
             run-in and treatment periods

          -  Ability and willingness to provide informed consent

        Exclusion Criteria:

          -  COPD exacerbation within preceding 6 weeks requiring treatment

          -  Significant respiratory (other than COPD), cardiovascular, neuropsychiatric, renal,
             gastrointestinal, or genitourinary disease that would interfere with participation in
             the study or interpretation of the results.

          -  Acute Myocardial infarction (MI) or Acute Coronary syndrome within 6 prior months

          -  Cancer (other than skin or localized prostate) within preceding 5 years

          -  Child-bearing potential with lack of adequate contraception, Pregnancy or lactation.
             Acceptable forms of birth control include abstinence, hysterectomy, tubal ligation,
             two of the following: vasectomy, condom, diaphragm, intrauterine device, oral or
             implanted contraceptives, or spermicide.

          -  Allergy to local anesthesia

          -  Resting hypoxemia (O2 saturation < 90%)

          -  Glomerular Filtration Rate (GFR) < 30

          -  Liver enzymes four times upper normal

          -  Current use of warfarin for any indication