COPDPhase 2BESTNCT01335971

Broccoli Sprout Extracts Trial to See if NRF2 is Enhanced by Sulforaphane Treatment in Patients With COPD

A Phase 2 study testing Sulforaphane 25 and Sulforaphane 150 in people with COPD, run by Johns Hopkins University at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 40 years and older
Conditions the study is for: COPD
What is being tested?: Sulforaphane 25 and Sulforaphane 150
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 89 participants
Where: 3 sitesUnited States
Study dates: Sep 2010to Jun 2015
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 10Show fewer

Resting hypoxemia (O2 saturation < 90%)
Glomerular Filtration Rate (GFR) < 30
Liver enzymes four times upper normal
Current use of warfarin for any indication

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Johns Hopkins School of Medicine
Baltimore, Maryland, 21224
University at Baffalo, The State University of New York
Buffalo, New York, 14215
Temple University
Philadelphia, Pennsylvania, 19122

Other trials in United States

About this study

Official title: Enhancing Nrf2 by Sulforaphane Treatment in COPD

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.

Read the detailed description

Chronic Obstructive Pulmonary Disease (COPD) is a major cause of morbidity and mortality in the United States and is a growing cause of chronic disease internationally. Presently, there are limited treatment options for this disease to modify the progression of airflow obstruction and decrease periodic exacerbations. Recent evidence has emphasized the central role of oxidative stress as a mechanism of COPD pathobiology. Evidence from investigators' group has shown that COPD patients and animals exposed to cigarette smoke have impairment of antioxidant defenses which are caused by a defect in activity of nuclear factor erythroid 2 like 2 (Nrf2), a prolific regulator of anti-oxidant enzymes, glutathione homeostasis, and cytoprotective proteins. Activation of Nrf2 protects mice with chronic smoke exposure from developing emphysema, decreases oxidative stress, increases proteasomal anti-apoptotic cytoprotective responses, improves bacterial phagocytosis and killing, and reverses tobacco-smoke induced corticosteroid resistance. Similarly, in vitro Nrf2 activation in human COPD lung cells has shown improved cytoprotection, improved bacterial clearance, and restoration of steroid sensitivity. This trial focuses on sulforaphane, a derivative of cruciferous vegetables, which is a potent in vitro and in vivo stimulator of Nrf2 activity. The investigators want to investigate whether ingestion of sulforaphane by chronic obstructive pulmonary disease (COPD) patients will increase Nrf2 activity and expression of downstream antioxidants in alveolar macrophages and bronchial epithelial cells. 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. Collections of alveolar macrophages by Bronchoalveolar lavage (BAL), bronchial epithelial cells by endobronchial brushings will be performed at baseline and 4 weeks. Other bio-specimens will include nasal epithelial cells, Peripheral Blood Monocyte Collection (PBMCs), and expired breath condensate (EBC). 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. Ancillary studies are proposed to explore the efficacy and mechanisms of sulforaphane to increase bacterial clearance and to restore steroid sensitivity in COPD lung cells.

Conditions: COPD
Being tested: Sulforaphane 25, Sulforaphane 150, Placebo
Keywords: COPD, Nrf2, Sulforaphane
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sulforaphane 25Drug
Also called This is derived from broccoli sprouts.
25 micromoles (4.4 mg) sulforaphane daily by mouth
Sulforaphane 150Dietary supplement
150 micromoles (26.6 mg) sulforaphane daily by mouth
PlaceboOther
Microcrystalline cellulose once daily by mouth

Study groups in NCT01335971
Study group	Role	What they receive
Sulforaphane 25	Active comparator	25 micromoles (4.4 mg) sulforaphane daily by mouth Receives: Drug: Sulforaphane 25
Sulforaphane 150	Active comparator	150 micromoles (26.6 mg) sulforaphane daily by mouth Receives: Dietary Supplement: Sulforaphane 150
Placebo	Placebo comparator	Microcrystalline cellulose Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Alveolar Macrophage Expression of Nrf2 and Associated Genes at 4 Weeks
The first primary design variable is the change from baseline in nuclear factor erythroid 2 like 2 (Nrf2) expression in alveolar macrophages (AM) at 4 weeks by analysing Nrf2 protein and expression of a panel of Nrf2 regulated genes.Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage for primary outcome data.
Measured: Baseline and 4 weeks
Change From Baseline in Bronchial Epithelial Cell Expression of Nrf2 at 4 Weeks
The second primary design variable is the change from baseline in nuclear factor erythroid 2 like 2 (Nrf2) expression in bronchial epithelial cells (BEC) at 4 weeks by analysing Nrf2 protein. Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage for primary outcome data.
Measured: Baseline and 4 weeks
Change From Baseline in Bronchial Epithelial Cell Expression of NQ01 and Keap1 at 4 Weeks
The third primary design variable is the change from baseline in NAD(P)H Quinone Dehydrogenase 1 (NQ01) and Kelch Like ECH Associated Protein 1 (Keap1) expression in bronchial epithelial cells (BEC) at 4 weeks. Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage for primary outcome data.
Measured: Baseline and 4 weeks
Change From Baseline in Bronchial Epithelial Cell Expression of HO1 at 4 Weeks
The fourth primary design variable is the change from baseline in expression of Heme Oxygenase 1 (HO1) in bronchial epithelial cells (BEC) at 4 weeks. Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage for primary outcome data.
Measured: Baseline and 4 weeks
Change From Baseline in Bronchial Epithelial Cell Expression of AKR1C1 at 4 Weeks
The fifth primary design variable is the change from baseline in expression of Aldo-Keto Reductase Family 1 Member C1 (AKR1C1) in bronchial epithelial cells (BEC) at 4 weeks. Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage for primary outcome data.
Measured: Baseline and 4 weeks
Change From Baseline in Bronchial Epithelial Cell Expression of AKR1C3 at 4 Weeks
The sixth primary design variable is the change from baseline in expression of Aldo-Keto Reductase Family 1 Member C3 (AKR1C3) in bronchial epithelial cells (BEC) at 4 weeks. Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage for primary outcome data.
Measured: Baseline and 4 weeks

Secondary outcomes (4)

Fold-change in Isoprostane Concentrations (Follow-up to Baseline)
Isoprostane, an oxidant stress indicator, was measured in expired breath condensate at baseline and 4 weeks.
Measured: Baseline and 4 weeks
Fold-change in Serum Inflammatory Marker Concentrations (Follow-up to Baseline)
Inflammatory markers were measured in serum samples derived from venipuncture at baseline and 4 weeks in the serum of the participants of the trial.
Measured: Baseline and 4 weeks
Fold-change in Inflammatory Marker Concentrations in Bronchial Alveolar Lavage (Follow-up to Baseline) by Treatment Group
Inflammatory markers were measured in bronchial alveolar lavage samples at baseline and 4 weeks in the participants of this trial who had bronchoalveolar lavage samples obtained.Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage.
Measured: Baseline and 4 weeks
Fold-change in Plasma Inflammatory Marker Concentrations (Follow-up to Baseline)
Inflammatory markers were measured in plasma at baseline and 4 weeks. Thiobarbituric acid reactive substances were measured in nmol malondialdehyde (MDA)/mL.
Measured: Baseline and 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2010Jun 2015

First posted15 Apr 2011 (estimated)
Study startSep 2010
Primary completionJul 2013
Study completionJun 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for COPDStudies of the same condition, open and under way.
More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 89 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01335971
Sponsor's protocol ID: 1U01HL105569
Other IDs: RFA-HL-10-003
Acronym: BEST
Status last verified: Apr 2017
First submitted: 8 Apr 2011
Last updated: 19 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: The primary method of data-sharing will be through the traditional mechanism of publication of results in the peer-reviewed medical literature. Following publication of the main results, in accordance with NIH policy, a de-identified, HIPAA-compliant limited use dataset will be made available to qualified investigators who have Institutional Review Board approval and sign a data-use agreement. De-identified specimens collected in the study that are not analyzed for the main study will be made available to qualified investigators along with a limited use dataset in line with University and Office of Human Research Protections guidelines with a materials transfer agreement and/or data-use agreement as applicable. The Center for Clinical Trials has extensive experience in preparation of limited use datasets, and maintains policies and model agreements for data-use agreements and materials-transfer agreements.

Publications

Sidhaye VK, Holbrook JT, Burke A, Sudini KR, Sethi S, Criner GJ, Fahey JW, Berenson CS, Jacobs MR, Thimmulappa R, Wise RA, Biswal S. Compartmentalization of anti-oxidant and anti-inflammatory gene expression in current and former smokers with COPD. Respir Res. 2019 Aug 20;20(1):190. doi: 10.1186/s12931-019-1164-1.
PubMed 31429757
Wise RA, Holbrook JT, Criner G, Sethi S, Rayapudi S, Sudini KR, Sugar EA, Burke A, Thimmulappa R, Singh A, Talalay P, Fahey JW, Berenson CS, Jacobs MR, Biswal S; Broccoli Sprout Extract Trial Research Group. Lack of Effect of Oral Sulforaphane Administration on Nrf2 Expression in COPD: A Randomized, Double-Blind, Placebo Controlled Trial. PLoS One. 2016 Nov 10;11(11):e0163716. doi: 10.1371/journal.pone.0163716. eCollection 2016.
PubMed 27832073

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All COPD trials

Study at a glance

From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Enhancing Nrf2 by Sulforaphane Treatment in COPD
ClinicalTrials.gov ID: NCT01335971
Acronym / sponsor ID: BEST / 1U01HL105569
Conditions: COPD
Keywords: COPD, Nrf2, Sulforaphane
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 89 participants (actual)
Lead sponsor: Johns Hopkins UniversityUniversity, hospital or other
Collaborators: Temple University, State University of New York at Buffalo
Study start: Sep 2010 (actual)
Primary completion: Jul 2013 (actual)
Study completion: Jun 2015 (actual)
First posted: 15 Apr 2011 (estimated)
Results: Posted 19 May 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Sulforaphane 25	Active comparator	Drug: Sulforaphane 2525 micromoles (4.4 mg) sulforaphane daily by mouth
Sulforaphane 150	Active comparator	Dietary Supplement: Sulforaphane 150150 micromoles (26.6 mg) sulforaphane daily by mouth
Placebo	Placebo comparator	Other: PlaceboMicrocrystalline cellulose

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (10 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sulforaphane 25Also: This is derived from broccoli sprouts.25 micromoles (4.4 mg) sulforaphane daily by mouth	Drug	Sulforaphane 25
Sulforaphane 150150 micromoles (26.6 mg) sulforaphane daily by mouth	Dietary supplement	Sulforaphane 150
PlaceboMicrocrystalline cellulose once daily by mouth	Other	Placebo

Primary outcome

Change From Baseline in Alveolar Macrophage Expression of Nrf2 and Associated Genes at 4 Weeks
Time frame: Baseline and 4 weeks
The first primary design variable is the change from baseline in nuclear factor erythroid 2 like 2 (Nrf2) expression in alveolar macrophages (AM) at 4 weeks by analysing Nrf2 protein and expression of a panel of Nrf2 regulated genes.Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage for primary outcome data.
Change From Baseline in Bronchial Epithelial Cell Expression of Nrf2 at 4 Weeks
Time frame: Baseline and 4 weeks
The second primary design variable is the change from baseline in nuclear factor erythroid 2 like 2 (Nrf2) expression in bronchial epithelial cells (BEC) at 4 weeks by analysing Nrf2 protein. Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage for primary outcome data.
Change From Baseline in Bronchial Epithelial Cell Expression of NQ01 and Keap1 at 4 Weeks
Time frame: Baseline and 4 weeks
The third primary design variable is the change from baseline in NAD(P)H Quinone Dehydrogenase 1 (NQ01) and Kelch Like ECH Associated Protein 1 (Keap1) expression in bronchial epithelial cells (BEC) at 4 weeks. Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage for primary outcome data.
Change From Baseline in Bronchial Epithelial Cell Expression of HO1 at 4 Weeks
Time frame: Baseline and 4 weeks
The fourth primary design variable is the change from baseline in expression of Heme Oxygenase 1 (HO1) in bronchial epithelial cells (BEC) at 4 weeks. Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage for primary outcome data.
Change From Baseline in Bronchial Epithelial Cell Expression of AKR1C1 at 4 Weeks
Time frame: Baseline and 4 weeks
The fifth primary design variable is the change from baseline in expression of Aldo-Keto Reductase Family 1 Member C1 (AKR1C1) in bronchial epithelial cells (BEC) at 4 weeks. Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage for primary outcome data.
Change From Baseline in Bronchial Epithelial Cell Expression of AKR1C3 at 4 Weeks
Time frame: Baseline and 4 weeks
The sixth primary design variable is the change from baseline in expression of Aldo-Keto Reductase Family 1 Member C3 (AKR1C3) in bronchial epithelial cells (BEC) at 4 weeks. Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage for primary outcome data.

4 secondary outcomes

Fold-change in Isoprostane Concentrations (Follow-up to Baseline)
Time frame: Baseline and 4 weeks
Fold-change in Serum Inflammatory Marker Concentrations (Follow-up to Baseline)
Time frame: Baseline and 4 weeks
Fold-change in Inflammatory Marker Concentrations in Bronchial Alveolar Lavage (Follow-up to Baseline) by Treatment Group
Time frame: Baseline and 4 weeks
Fold-change in Plasma Inflammatory Marker Concentrations (Follow-up to Baseline)
Time frame: Baseline and 4 weeks

Results and safety

Results posted to the registry on 19 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	31	29
Sulforaphane 25	29	28
Sulforaphane 150	29	28

Primary outcome: Change From Baseline in Alveolar Macrophage Expression of Nrf2 and Associated Genes at 4 Weeks

Time frame: Baseline and 4 weeks. Median (Inter-Quartile Range). Unit: fold change

Measure	Placebo n = 27	Sulforaphane 25 n = 27	Sulforaphane 150 n = 27
NQ01	0.80 (0.53 to 1.09)	1.03 (0.56 to 1.60)	0.94 (0.59 to 1.72)
HO1	0.90 (0.69 to 1.34)	0.98 (0.83 to 1.31)	1.06 (0.68 to 1.74)
AKR1C1	0.81 (0.46 to 1.27)	1.13 (0.38 to 1.99)	0.71 (0.56 to 1.57)
AKR1C3	1.03 (0.76 to 1.37)	1.02 (0.67 to 1.31)	0.87 (0.40 to 1.32)
Nrf2	1.14 (0.79 to 1.52)	1.05 (0.87 to 1.47)	1.13 (0.74 to 1.28)
Keap1	0.94 (0.66 to 1.17)	0.99 (0.82 to 1.11)	1.06 (0.59 to 1.32)

Placebo vs Sulforaphane 25 vs Sulforaphane 150: p = 0.45, Kruskal-Wallis
Placebo vs Sulforaphane 25 vs Sulforaphane 150: p = 0.40, Kruskal-Wallis
Placebo vs Sulforaphane 25 vs Sulforaphane 150: p = 0.75, Kruskal-Wallis

Population analysed: Number of participants analyzed based on number of individuals with alveolar macrophage samples in which assays could be successfully performed. Assays failed for two participants in the placebo group, one in the 25 micromole group, and one in the 150 micromole group.

Primary outcome: Change From Baseline in Bronchial Epithelial Cell Expression of Nrf2 at 4 Weeks

Time frame: Baseline and 4 weeks. Median (Inter-Quartile Range). Unit: fold change

Measure	Placebo n = 28	Sulforaphane 25 n = 27	Sulforaphane 150 n = 28
Value	1.09 (0.88 to 1.30)	1.06 (0.92 to 1.28)	1.06 (0.76 to 1.31)

Placebo vs Sulforaphane 25 vs Sulforaphane 150: p = 0.68, Kruskal-Wallis

Population analysed: Number of participants analyzed based on number of individuals with bronchial epithelial samples in which assays could be successfully performed. Assays failed for one participant in the placebo group and one in the 25 micromole group..

Primary outcome: Change From Baseline in Bronchial Epithelial Cell Expression of NQ01 and Keap1 at 4 Weeks

Time frame: Baseline and 4 weeks. Median (Inter-Quartile Range). Unit: fold change

Measure	Placebo n = 27	Sulforaphane 25 n = 28	Sulforaphane 150 n = 27
NQ01	1.09 (0.83 to 1.50)	1.12 (0.89 to 1.53)	0.96 (0.65 to 1.41)
KEAP1	1.12 (0.71 to 1.54)	1.39 (0.99 to 2.24)	0.87 (0.58 to 1.10)

Placebo vs Sulforaphane 25 vs Sulforaphane 150: p = 0.69, Kruskal-Wallis
Placebo vs Sulforaphane 25 vs Sulforaphane 150: p <0.01, Kruskal-Wallis

Population analysed: Number of participants analyzed based on number of individuals with bronchial epithelial samples in which assays could be successfully performed. Assays failed for two participants in the placebo group and one in the 150 micromole group.

Primary outcome: Change From Baseline in Bronchial Epithelial Cell Expression of HO1 at 4 Weeks

Time frame: Baseline and 4 weeks. Median (Inter-Quartile Range). Unit: fold change

Measure	Placebo n = 28	Sulforaphane 25 n = 28	Sulforaphane 150 n = 28
Value	1.05 (0.60 to 1.23)	1.12 (0.82 to 1.67)	0.93 (0.62 to 1.45)

Placebo vs Sulforaphane 25 vs Sulforaphane 150: p = 0.53, Kruskal-Wallis

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 31 (0%)	15 of 31 (48.4%)	Not reported
Sulforaphane 25	2 of 29 (6.9%)	21 of 29 (72.4%)	Not reported
Sulforaphane 150	1 of 29 (3.4%)	18 of 29 (62.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31429757Sidhaye VK, Holbrook JT, Burke A, Sudini KR, Sethi S, Criner GJ, Fahey JW, Berenson CS, Jacobs MR, Thimmulappa R, Wise RA, Biswal S. Compartmentalization of anti-oxidant and anti-inflammatory gene expression in current and former smokers with COPD. Respir Res. 2019 Aug 20;20(1):190. doi: 10.1186/s12931-019-1164-1.
Derived from this study: PubMed 27832073Wise RA, Holbrook JT, Criner G, Sethi S, Rayapudi S, Sudini KR, Sugar EA, Burke A, Thimmulappa R, Singh A, Talalay P, Fahey JW, Berenson CS, Jacobs MR, Biswal S; Broccoli Sprout Extract Trial Research Group. Lack of Effect of Oral Sulforaphane Administration on Nrf2 Expression in COPD: A Randomized, Double-Blind, Placebo Controlled Trial. PLoS One. 2016 Nov 10;11(11):e0163716. doi: 10.1371/journal.pone.0163716. eCollection 2016.
Individual participant dataSharing planned: Yes. The primary method of data-sharing will be through the traditional mechanism of publication of results in the peer-reviewed medical literature. Following publication of the main results, in accordance with NIH policy, a de-identified, HIPAA-compliant limited use dataset will be made available to qualified investigators who have Institutional Review Board approval and sign a data-use agreement. De-identified specimens collected in the study that are not analyzed for the main study will be made available to qualified investigators along with a limited use dataset in line with University and Office of Human Research Protections guidelines with a materials transfer agreement and/or data-use agreement as applicable. The Center for Clinical Trials has extensive experience in preparation of limited use datasets, and maintains policies and model agreements for data-use agreements and materials-transfer agreements.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Janet T Holbrook, PhD, MPH principal investigator

Johns Hopkins Bloomberg School of Public Health

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sulforaphane 25 and Sulforaphane 150 in people with COPD, run by Johns Hopkins University at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Alveolar Macrophage Expression of Nrf2 and Associated Genes at 4 Weeks (time frame: Baseline and 4 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01335971, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2017.