Broccoli Sprout Extracts Trial to See if NRF2 is Enhanced by Sulforaphane Treatment in Patients With COPD
Completed · Phase 2 · Has a placebo group
Conditions studied: COPD
In brief
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.
Key facts
- Study ID
- NCT01335971
- Run by
- Johns Hopkins University
- People needed
- 89
- Starts
- 2010-09-01
- Expected to finish
- 2015-06-01
- Last updated by the study team
- 2017-05-19
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Johns Hopkins School of Medicine — Baltimore, Maryland, United States
- University at Baffalo, The State University of New York — Buffalo, New York, United States
- Temple University — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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