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

This study has been completed.
Sponsor:
Collaborators:
Temple University
State University of New York at Buffalo
Information provided by (Responsible Party):
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01335971
First received: April 8, 2011
Last updated: April 11, 2017
Last verified: April 2017
Results First Received: August 25, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Investigator, Outcomes Assessor;   Primary Purpose: Treatment
Condition: COPD
Interventions: Drug: Sulforaphane 25
Dietary Supplement: Sulforaphane 150
Other: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo

Microcrystalline cellulose

Placebo: Microcrystalline cellulose once daily by mouth

Sulforaphane 25

25 micromoles (4.4 mg) sulforaphane daily by mouth

Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth

Sulforaphane 150

150 micromoles (26.6 mg) sulforaphane daily by mouth

Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth


Participant Flow:   Overall Study
    Placebo   Sulforaphane 25   Sulforaphane 150
STARTED   31   29   29 
COMPLETED   29   28   28 
NOT COMPLETED   2   1   1 
Withdrawal by Subject                1                0                0 
Did not complete bronchoscopy                1                1                1 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo

Microcrystalline cellulose

Placebo: Microcrystalline cellulose once daily by mouth

Sulforaphane 25

25 micromoles (4.4 mg) sulforaphane daily by mouth

Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth

Sulforaphane 150

150 micromoles (26.6 mg) sulforaphane daily by mouth

Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth

Total Total of all reporting groups

Baseline Measures
   Placebo   Sulforaphane 25   Sulforaphane 150   Total 
Overall Participants Analyzed 
[Units: Participants]
 31   29   29   89 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      22  71.0%      24  82.8%      19  65.5%      65  73.0% 
>=65 years      9  29.0%      5  17.2%      10  34.5%      24  27.0% 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 59 
 (52 to 67) 
 59 
 (54 to 65) 
 56 
 (52 to 62) 
 58 
 (54 to 65) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      15  48.4%      12  41.4%      8  27.6%      35  39.3% 
Male      16  51.6%      17  58.6%      21  72.4%      54  60.7% 
Region of Enrollment 
[Units: Participants]
       
United States   31   29   29   89 
Chronic obstructive pulmonary disease (COPD) characteristics 
[Units: Participants]
       
10 or more pack years of smoking history   30   29   29   88 
Smoke cigarettes now   20   16   18   54 
Smoke 10 or more cigarettes a day now   10   9   10   29 
COPD exacerbation in last 12 months   5   7   7   19 
Post bronchodilator FEV1 [1] 
[Units: Percent predicted]
Median (Inter-Quartile Range)
 61 
 (54 to 70) 
 54 
 (50 to 65) 
 65 
 (55 to 72) 
 61 
 (53 to 70) 
[1] Forced expiratory volume in 1 second (FEV1) after administration of bronchodilator
Post bronchodilator FEV1/FVC ratio [1] 
[Units: Ratio]
Median (Inter-Quartile Range)
 0.56 
 (0.51 to 0.63) 
 0.52 
 (0.47 to 0.59) 
 0.57 
 (0.50 to 0.63) 
 0.56 
 (0.48 to 0.62) 
[1] Ratio of forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) after bronchodilation
Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) [1] 
[Units: mL/mmHg/min]
Median (Inter-Quartile Range)
 14.8 
 (11.8 to 19.5) 
 15.7 
 (12.1 to 19.3) 
 16.3 
 (12.3 to 21.4) 
 15.7 
 (12.1 to 20.9) 
[1] DLCO: Diffusing capacity of the lungs for carbon monoxide measured by the single breath technique in accordance with American Thoracic Society standards
Pulse oximetry (SpO2) 
[Units: Percentage of oxyhemoglobin]
Median (Inter-Quartile Range)
 95 
 (94 to 97) 
 96 
 (95 to 97) 
 96 
 (94 to 97) 
 96 
 (94 to 97) 
Pulmonary function measures [1] 
[Units: Liters]
Median (Inter-Quartile Range)
       
Total lung capacity   6.0 
 (4.7 to 7.3) 
 5.5 
 (4.9 to 6.8) 
 6.3 
 (5.7 to 7.0) 
 6.0 
 (5.0 to 7.2) 
Slow vital capacity   3.1 
 (2.4 to 4.1) 
 3.0 
 (2.8 to 3.7) 
 3.7 
 (3.1 to 4.4) 
 3.3 
 (2.7 to 4.1) 
Forced residual capacity   3.6 
 (3.1 to 4.5) 
 3.6 
 (3.0 to 4.1) 
 3.4 
 (3.0 to 3.9) 
 3.5 
 (3.0 to 4.2) 
Residual volume   2.6 
 (2.5 to 3.4) 
 2.6 
 (2.2 to 3.5) 
 2.7 
 (2.3 to 2.9) 
 2.6 
 (2.2 to 3.2) 
[1] Values were determined using either helium dilution or plethysmography methods, depending on equipment available at study sites. Lung volumes were measured in accordance with local hospital procedures.
Use of respiratory medications in prior 2 weeks 
[Units: Participants]
       
Short-acting beta-agonist   22   21   18   61 
Long-acting beta-agonist   2   1   2   5 
Long-acting beta-agonist & inhaled corticosteroid   14   13   13   40 
Long-acting anticholinergic bronchodilator   7   9   10   26 
Medical Research Council Dyspnea Score [1] 
[Units: Units on a scale]
Median (Inter-Quartile Range)
 2 
 (1 to 3) 
 2 
 (2 to 3) 
 2 
 (1 to 3) 
 2 
 (1 to 3) 
[1] Minimum score 1, maximum score 5. Higher values represent a worse outcome.
St Georges Respiratory Questionnaire [1] 
[Units: Units on a scale]
Median (Inter-Quartile Range)
       
Total score   43 
 (24 to 58) 
 47 
 (27 to 56) 
 39 
 (24 to 54) 
 40 
 (26 to 56) 
Symptoms score   58 
 (32 to 70) 
 55 
 (43 to 68) 
 50 
 (31 to 57) 
 52 
 (36 to 68) 
Activity score   54 
 (30 to 74) 
 60 
 (47 to 74) 
 50 
 (41 to 73) 
 55 
 (36 to 74) 
Impacts score   27 
 (17 to 44) 
 34 
 (15 to 46) 
 26 
 (13 to 42) 
 28 
 (15 to 44) 
[1]

Scales, ranges, and descriptors:

All scores are expressed as a percentage of overall impairment where 100 is the worst possible health status and 0 is the best possible health status.

Total score (all items) summarizes the impact of the disease on overall health status Symptoms score (Q1-8) looks at the effect of respiratory symptoms, their frequency and severity.

Activity score (Q11-17, 37-45) measures activities causing or limited by breathlessness Impacts score (Q18-36, 46-52) covers a range of aspects re: social functioning and psychological disturbances resulting from airways disease



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Alveolar Macrophage Expression of Nrf2 and Associated Genes at 4 Weeks   [ Time Frame: Baseline and 4 weeks ]

2.  Primary:   Change From Baseline in Bronchial Epithelial Cell Expression of Nrf2 at 4 Weeks   [ Time Frame: Baseline and 4 weeks ]

3.  Primary:   Change From Baseline in Bronchial Epithelial Cell Expression of NQ01 and Keap1 at 4 Weeks   [ Time Frame: Baseline and 4 weeks ]

4.  Primary:   Change From Baseline in Bronchial Epithelial Cell Expression of HO1 at 4 Weeks   [ Time Frame: Baseline and 4 weeks ]

5.  Primary:   Change From Baseline in Bronchial Epithelial Cell Expression of AKR1C1 at 4 Weeks   [ Time Frame: Baseline and 4 weeks ]

6.  Primary:   Change From Baseline in Bronchial Epithelial Cell Expression of AKR1C3 at 4 Weeks   [ Time Frame: Baseline and 4 weeks ]

7.  Secondary:   Fold-change in Isoprostane Concentrations (Follow-up to Baseline)   [ Time Frame: Baseline and 4 weeks ]

8.  Secondary:   Fold-change in Serum Inflammatory Marker Concentrations (Follow-up to Baseline)   [ Time Frame: Baseline and 4 weeks ]

9.  Secondary:   Fold-change in Inflammatory Marker Concentrations in Bronchial Alveolar Lavage (Follow-up to Baseline) by Treatment Group   [ Time Frame: Baseline and 4 weeks ]

10.  Secondary:   Fold-change in Plasma Inflammatory Marker Concentrations (Follow-up to Baseline)   [ Time Frame: Baseline and 4 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Alexis Rea
Organization: Johns Hopkins University School of Medicine
phone: (443) 287-8496
e-mail: area5@jhu.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01335971     History of Changes
Obsolete Identifiers: NCT01318603
Other Study ID Numbers: 1U01HL105569 ( U.S. NIH Grant/Contract )
RFA-HL-10-003 ( Other Identifier: NHLBI )
Study First Received: April 8, 2011
Results First Received: August 25, 2016
Last Updated: April 11, 2017