CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 89 enrolled
Drug / intervention
Sulforaphane 25 +2 moredrug
Likely dose
Sulforaphane 25 4.4 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01335971
NCT01335971Phase 2Completed

Enhancing Nrf2 by Sulforaphane Treatment in COPD

Johns Hopkins University·interventional·Posted Apr 15, 2011·Updated May 19, 2017

In Brief

A Phase 2 clinical trial evaluating Sulforaphane 25, Sulforaphane 150, and 1 other intervention for COPD. Completed, enrolled 89 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOPD
CountriesUnited States

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 15, 2011
Enrollment StartSep 1, 2010
Primary CompletionJul 1, 2013
Study CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 15.2 years ago

Interventions

Sulforaphane 25drug

25 micromoles (4.4 mg) sulforaphane daily by mouth

Sulforaphane 150dietary

150 micromoles (26.6 mg) sulforaphane daily by mouth

Placeboother

Microcrystalline cellulose once daily by mouth