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CompletedNCT01967173BARDUpdated Nov 15, 2018Results posted

Best African American Response to Asthma Drugs

A Phase 3 interventional study of Flovent Diskus® 100 mcg and Flovent Diskus® 250 mcg in Asthma, sponsored by Milton S. Hershey Medical Center. Completed at 28 sites in United States. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2018-11-15.

Sponsored by Milton S. Hershey Medical Center · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
574
Allocation
Randomized
Ages
5 Years and older
Sex
All
01

Study summary

The purpose of this study is to find the best asthma treatment to add for Blacks who have asthma that is not well controlled on a low dose of inhaled steroid. This study will also try to find out if Black adults and children differ in how they respond to the medications used in this study.

Read the detailed description

BARD is a 66 week prospective, randomized, double-blind, crossover trial in Blacks (individuals who self-report Black ancestry) who have inadequately controlled asthma while taking low-dose inhaled corticosteroids (ICS). BARD will examine the efficacy of increasing the dose of ICS with or without the addition of a long-acting beta agonist (LABA) to determine whether individual patients respond better to one treatment than another and, if so, whether the responses are different for children and adults or if they are related to genetic ancestry.

02

Conditions studied

  • Asthma

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Keywords

  • Asthma
  • Fluticasone
  • Salmeterol
03

In context

Asthma

3,920 studies on the registry are indexed under Asthma; 506 are open to participants now.

This study's enrollment of 574 is above the median of 83 across 2,751 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Milton S. Hershey Medical Center is the lead sponsor of 480 studies on the registry; 61 are open to participants now.

Of its 56 completed or terminated interventional studies of FDA-regulated products, 42 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Individuals who self-report Black ancestry (with at least 1 Black grandparent).
  2. Able to perform reproducible spirometry according to ATS criteria.
  3. Clinical history consistent with asthma.
  4. Baseline FEV1≥40% of predicted and/or post-bronchodilator FEV1≥40% of predicted.
  5. Asthma confirmed either by: (1) Beta-agonist reversibility to 4 puffs albuterol ≥ 12% OR (2) PC20FEV1 ≤ 16 mg/ml OR (3) an absolute relative change in %predicted FEV1 of ≥ 12% over two measurements documented by repeat spirogram over the previous year
  6. Either: A) inadequately controlled on low-, medium- or high-dose ICS monotherapy, or low- or medium-dose ICS/LABA, or B) well-controlled on medium- or high-dose ICS monotherapy, or low-, medium- or high-dose ICS/LABA. Inadequate asthma control will be defined as an ACT/c-ACT score \<20; well-controlled asthma will be defined as an ACT/c-ACT score ≥20.
  7. Stable asthma controller therapy dose (ICS or ICS/LABA) for the 2 weeks prior to enrollment.
  8. Non-smoker (total lifetime smoking history \< 5 pack-years if \<18, or \<10 pack-years if ≥18 years of age; no smoking for at least 1 year).
  9. For participants ≥18 years of age: Ability to provide informed consent. For participants under 18 years of age: Ability to provide verbal or written assent and ability of parent to provide informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Medical contraindication to LABA or history of adverse reactions to ICS or LABA preparations or any of their ingredients.
  2. Current or prior use of medications known to significantly interact with corticosteroid disposition within the two-week period preceding enrollment.
  3. Unwilling to provide a blood sample for DNA extraction and genetic analysis.
  4. Major medical problems prohibiting study participation, i.e. presence of chronic or active lung disease other than asthma or history of unstable significant medical illness other than asthma, including thyroid disease, diabetes mellitus, Cushing's disease, Addison's disease, hepatic disease, or concurrent medical problems that could require oral corticosteroids during the study or that would place the participant at increased risk.
  5. Systemic corticosteroid treatment for any condition within 4 weeks of enrollment or more than five courses of systemic corticosteroids in the past year.
  6. History of a life-threatening asthma exacerbation requiring intubation, mechanical ventilation, or resulting in a hypoxic seizure within the last 2 years.
  7. History of a respiratory tract infection within 4 weeks of enrollment.
  8. If a female of child-bearing potential, failure to practice abstinence or use an acceptable birth control method.
  9. Pregnancy or lactation or planning to get pregnant during the course of the trial.
  10. Receiving hyposensitization therapy other than an established maintenance regimen defined as a continuous regimen for ≥ 3 months prior to enrollment.
  11. Participation in an intervention trial or use of investigative drugs in the past 30 days or plans to enroll in such a trial during the study.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
574 participants (actual)

Study arms

  • Experimental
    Crossover sequence 1

    Flovent Diskus® 250 mcg,followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 100 mcg, followed by Advair Diskus® 100/50 mcg

    Drug: Flovent Diskus® 100 mcg · Drug: Flovent Diskus® 250 mcg · Drug: Advair Diskus® 100/50 mcg · Drug: Advair Diskus® 250/50 mcg

  • Experimental
    Crossover sequence 2

    Advair Diskus® 250/50 mcg, followed by Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Flovent Diskus® 100 mcg

    Drug: Flovent Diskus® 100 mcg · Drug: Flovent Diskus® 250 mcg · Drug: Advair Diskus® 100/50 mcg · Drug: Advair Diskus® 250/50 mcg

  • Experimental
    Crossover sequence 3

    Flovent Diskus® 100 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 100/50 mcg, followed by Advair Diskus® 250/50 mcg

    Drug: Flovent Diskus® 100 mcg · Drug: Flovent Diskus® 250 mcg · Drug: Advair Diskus® 100/50 mcg · Drug: Advair Diskus® 250/50 mcg

  • Experimental
    Crossover sequence 4

    Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 100 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 250 mcg

    Drug: Flovent Diskus® 100 mcg · Drug: Flovent Diskus® 250 mcg · Drug: Advair Diskus® 100/50 mcg · Drug: Advair Diskus® 250/50 mcg

  • Experimental
    Crossover sequence 5

    Flovent Diskus® 500 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 100/50 mcg

    Drug: Flovent Diskus® 250 mcg · Drug: Flovent Diskus® 500 mcg · Drug: Advair Diskus® 100/50 mcg · Drug: Advair Diskus® 250/50 mcg

  • Experimental
    Crossover sequence 6

    Advair Diskus® 250/50 mcg, followed by Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 500 mcg, followed by Flovent Diskus® 250 mcg

    Drug: Flovent Diskus® 250 mcg · Drug: Flovent Diskus® 500 mcg · Drug: Advair Diskus® 100/50 mcg · Drug: Advair Diskus® 250/50 mcg

  • Experimental
    Crossover sequence 7

    Flovent Diskus® 250 mcg, followed by Flovent Diskus® 500 mcg, followed by Advair Diskus® 100/50 mcg, followed by Advair Diskus® 250/50 mcg

    Drug: Flovent Diskus® 250 mcg · Drug: Flovent Diskus® 500 mcg · Drug: Advair Diskus® 100/50 mcg · Drug: Advair Diskus® 250/50 mcg

  • Experimental
    Crossover sequence 8

    Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 500 mcg

    Drug: Flovent Diskus® 250 mcg · Drug: Flovent Diskus® 500 mcg · Drug: Advair Diskus® 100/50 mcg · Drug: Advair Diskus® 250/50 mcg

Interventions

  • DrugFlovent Diskus® 100 mcg

    Flovent is an ICS

  • DrugFlovent Diskus® 250 mcg

    Flovent is an ICS

  • DrugFlovent Diskus® 500 mcg

    Flovent is an ICS

  • DrugAdvair Diskus® 100/50 mcg

    Advair is an ICS/LABA combination

  • DrugAdvair Diskus® 250/50 mcg

    Advair is an ICS/LABA combination

06

What researchers measure

Primary outcomes

  1. The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen.

    This composite outcome uses a hierarchical method to ascertain differences in asthma control. For each participant, treatments are first compared to see if they differ in terms of exacerbations. If one treatment results in fewer exacerbations than another, it is deemed the superior treatment and no further comparisons are made. If treatment superiority cannot be assigned by exacerbations, then they are compared by asthma control days (ACDs). If one treatment yields at least 31 annualized ACDs more than another, it is deemed the superior treatment. If treatment superiority still cannot be assigned by ACDs, then they are compared by percent predicted FEV1 at the end of a treatment period. If one treatment yields at least 5% greater FEV1 than another, it is deemed the superior treatment. If treatment superiority cannot be assigned by exacerbations, ACDs or FEV1, then that participant is classified as having no differential response.

    Time frame: The last 12 weeks of each 14-week treatment period

07

Results

Posted Nov 15, 2018

Participant flow

Participant flow — Overall Study
MilestoneCrossover Sequence 1Crossover Sequence 2Crossover Sequence 3Crossover Sequence 4Crossover Sequence 5Crossover Sequence 6Crossover Sequence 7Crossover Sequence 8
Started6969717173727574
Completed 1st period5860676564626769
Completed 2nd period5258636263576361
Completed 3rd period4854606159565956
Completed 4th period4552555756495750
Completed4552555756495750
Not completed2417161417231824
Withdrew: Lost to follow-up532481268
Withdrew: Physician decision20211110
Withdrew: Lack of efficacy20220102
Withdrew: Pregnancy00000011
Withdrew: Adverse event00000001
Withdrew: Withdrawal by subject1514107891012

Outcome measures

PrimaryThe Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen.

This composite outcome uses a hierarchical method to ascertain differences in asthma control. For each participant, treatments are first compared to see if they differ in terms of exacerbations. If one treatment results in fewer exacerbations than another, it is deemed the superior treatment and no further comparisons are made. If treatment superiority cannot be assigned by exacerbations, then they are compared by asthma control days (ACDs). If one treatment yields at least 31 annualized ACDs more than another, it is deemed the superior treatment. If treatment superiority still cannot be assigned by ACDs, then they are compared by percent predicted FEV1 at the end of a treatment period. If one treatment yields at least 5% greater FEV1 than another, it is deemed the superior treatment. If treatment superiority cannot be assigned by exacerbations, ACDs or FEV1, then that participant is classified as having no differential response.

Time frame:
The last 12 weeks of each 14-week treatment period
Reported as:
Number · probability
The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen.
probabilityAdolescents and AdultsChildren
Advair 100/50 superior to Flovent 250.49.46
Advair 100/50 inferior to Flovent 250.28.46
Advair 100/50 superior to Flovent 500.53—
Advair 100/50 inferior to Flovent 500.27—
Advair 100/50 superior to Advair 250/50.42.47
Advair 100/50 inferior to Advair 250/50.36.49
Advair 100/50 superior to Flovent 100—.53
Advair 100/50 inferior to Flovent 100—.41
Advair 250/50 superior to Flovent 250.46.43
Advair 250/50 inferior to Flovent 250.33.47
Advair 250/50 superior to Flovent 500.49—
Advair 250/50 inferior to Flovent 500.31—
Flovent 500 superior to Flovent 250.35—
Flovent 500 inferior to Flovent 250.40—
Flovent 250 superior to Flovent 100—.51
Flovent 250 inferior to Flovent 100—.37
Statistical analysis
  • Adolescents and Adults · Mixed Models Analysis · p = 0.003
  • Children · Mixed Models Analysis · p = 0.9
  • Adolescents and Adults · Mixed Models Analysis · p = <0.001
  • Adolescents and Adults · Mixed Models Analysis · p = 0.42
  • Children · Mixed Models Analysis · p = 0.84
  • Adolescents and Adults · Mixed Models Analysis · p = 0.015
  • Adolescents and Adults · Mixed Models Analysis · p = 0.085
  • Children · Mixed Models Analysis · p = 0.62
  • Adolescents and Adults · Mixed Models Analysis · p = 0.48
  • Children · Mixed Models Analysis · p = 0.14
  • Children · Mixed Models Analysis · p = 0.096

Adverse events

Collected over Each participant was followed over the course of four 14-week treatment periods for a total of 56 weeks. The adverse events recorded below are reported at the treatment period level and represent 14 weeks of "at risk" exposure time.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Flovent 250 in Pediatric Group0/280 (0%)8/280 (2.9%)64/280 (22.9%)
Advair 250/50 in Pediatric Group0/280 (0%)1/280 (0.4%)52/280 (18.6%)
Flovent 100 in Pediatric Group0/280 (0%)2/280 (0.7%)43/280 (15.4%)
Advair 100/50 in Pediatric Group0/280 (0%)4/280 (1.4%)27/280 (9.6%)
Flovent 500 in Adolescent/Adult Group0/294 (0%)10/294 (3.4%)53/294 (18%)
Advair 250/50 in Adolescent/Adult Group0/294 (0%)7/294 (2.4%)47/294 (16%)
Flovent 250 in Adolescent/Adult Group0/294 (0%)7/294 (2.4%)35/294 (11.9%)
Advair 100/50 in Adolescent/Adult Group0/294 (0%)8/294 (2.7%)34/294 (11.6%)
Most frequent serious events
Showing 10 of 23
Most frequent serious events
EventFlovent 250 in Pediatric GroupAdvair 250/50 in Pediatric GroupFlovent 100 in Pediatric GroupAdvair 100/50 in Pediatric GroupFlovent 500 in Adolescent/Adult GroupAdvair 250/50 in Adolescent/Adult GroupFlovent 250 in Adolescent/Adult GroupAdvair 100/50 in Adolescent/Adult Group
Asthma ExacerbationRespiratory, thoracic and mediastinal disorders6/2801/2801/2802/2804/2942/2941/2943/294
PneumoniaRespiratory, thoracic and mediastinal disorders0/2800/2800/2800/2801/2940/2942/2940/294
FluRespiratory, thoracic and mediastinal disorders1/2800/2800/2800/2800/2940/2940/2941/294
Closed FractureInjury, poisoning and procedural complications0/2800/2800/2801/2800/2940/2940/2940/294
Intermittent Explosive DisorderPsychiatric disorders0/2800/2800/2801/2800/2940/2940/2940/294
Altered Mental StatusPsychiatric disorders0/2800/2801/2800/2800/2940/2940/2940/294
Convulsions Not Elsewhere ClassifiedGeneral disorders1/2800/2800/2800/2800/2940/2940/2940/294
AnemiaBlood and lymphatic system disorders0/2800/2800/2800/2800/2940/2941/2940/294
Acute PericarditisCardiac disorders0/2800/2800/2800/2800/2940/2941/2940/294
Acute GastritisGastrointestinal disorders0/2800/2800/2800/2801/2940/2940/2940/294
Most frequent other events
Most frequent other events
EventFlovent 250 in Pediatric GroupAdvair 250/50 in Pediatric GroupFlovent 100 in Pediatric GroupAdvair 100/50 in Pediatric GroupFlovent 500 in Adolescent/Adult GroupAdvair 250/50 in Adolescent/Adult GroupFlovent 250 in Adolescent/Adult GroupAdvair 100/50 in Adolescent/Adult Group
Asthma ExacerbationRespiratory, thoracic and mediastinal disorders23/28020/28040/28018/28018/29417/29417/29418/294
Acute NasopharyngitisRespiratory, thoracic and mediastinal disorders20/28018/28019/28020/28024/29427/29420/29422/294
Acute Upper Respiratory Tract InfectionRespiratory, thoracic and mediastinal disorders16/28010/28011/28011/28011/29411/29416/29413/294
FeverGeneral disorders10/2806/28016/2808/2804/2943/2940/2944/294
CoughGeneral disorders11/28010/28013/28015/2802/2943/2946/2943/294

Baseline characteristics

All randomized participants

Age, Continuous
Age, Continuous(years)Crossover Sequence 1Crossover Sequence 2Crossover Sequence 3Crossover Sequence 4Crossover Sequence 5Crossover Sequence 6Crossover Sequence 7Crossover Sequence 8Total
Mean8.7 ± 2.08.5 ± 1.78.4 ± 1.98.4 ± 1.838.5 ± 16.538.5 ± 15.939.3 ± 16.035.6 ± 16.023.2 ± 18.5
Sex: Female, Male
Sex: Female, Male(Participants)Crossover Sequence 1Crossover Sequence 2Crossover Sequence 3Crossover Sequence 4Crossover Sequence 5Crossover Sequence 6Crossover Sequence 7Crossover Sequence 8Total
Female2927262852484752309
Male4042454321242822265
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Crossover Sequence 1Crossover Sequence 2Crossover Sequence 3Crossover Sequence 4Crossover Sequence 5Crossover Sequence 6Crossover Sequence 7Crossover Sequence 8Total
Hispanic or Latino7476222333
Not Hispanic or Latino6265646571707371541
Unknown or Not Reported000000000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Crossover Sequence 1Crossover Sequence 2Crossover Sequence 3Crossover Sequence 4Crossover Sequence 5Crossover Sequence 6Crossover Sequence 7Crossover Sequence 8Total
Black6365686669717473549
Other6435411125
Region of Enrollment
Region of Enrollment(participants)Crossover Sequence 1Crossover Sequence 2Crossover Sequence 3Crossover Sequence 4Crossover Sequence 5Crossover Sequence 6Crossover Sequence 7Crossover Sequence 8Total
United States6969717173727574574
Forced expiratory volume at one second (FEV1) Percent of Predicted
Forced expiratory volume at one second (FEV1) Percent of Predicted(percent)Crossover Sequence 1Crossover Sequence 2Crossover Sequence 3Crossover Sequence 4Crossover Sequence 5Crossover Sequence 6Crossover Sequence 7Crossover Sequence 8Total
Mean98.1 ± 15.492.6 ± 17.995 ± 13.696.2 ± 19.183.8 ± 19.182.9 ± 15.583.7 ± 17.383.4 ± 1889.3 ± 18.1
Asthma Control Test
Asthma Control Test(units on a scale)Crossover Sequence 1Crossover Sequence 2Crossover Sequence 3Crossover Sequence 4Crossover Sequence 5Crossover Sequence 6Crossover Sequence 7Crossover Sequence 8Total
Mean————18.9 ± 3.818.6 ± 3.919.2 ± 3.718.8 ± 3.818.9 ± 3.8
Childhood Asthma Control Test
Childhood Asthma Control Test(units on a scale)Crossover Sequence 1Crossover Sequence 2Crossover Sequence 3Crossover Sequence 4Crossover Sequence 5Crossover Sequence 6Crossover Sequence 7Crossover Sequence 8Total
Mean21.5 ± 3.721.2 ± 3.620.7 ± 4.122.1 ± 3.6————21.4 ± 3.8
08

Study locations

28 sites
  • University of Arizona College of Medicine
    Tucson, Arizona 85724, United States
  • Children's Hospital & Research Center Oakland
    Oakland, California 94609, United States
  • UCSF Benioff Children's Hospital
    San Francisco, California 94143, United States
  • University of California - San Francisco
    San Francisco, California 94143, United States
  • National Jewish Health
    Denver, Colorado 80206, United States
  • Nemours Children's Clinic
    Jacksonville, Florida 32207, United States
  • Nemours Children's Clinic
    Orlando, Florida 32827, United States
  • Emory University
    Atlanta, Georgia 30322, United States
  • Northwestern Memorial Hospital
    Chicago, Illinois 60611, United States
  • Rush University Medical Center
    Chicago, Illinois 60612, United States
  • University of Illinois at Chicago
    Chicago, Illinois 60612, United States
  • Ann and Robert H. Lurie Children's Hospital
    Chicago, Illinois 60614, United States
  • University of Chicago
    Chicago, Illinois 60637, United States
  • Brigham & Women's Hospital
    Boston, Massachusetts 02115, United States
  • Children's Hospital Boston
    Boston, Massachusetts 02115, United States
  • St. Louis Children's Hospital
    Saint Louis, Missouri 63110, United States
  • Washington University
    Saint Louis, Missouri 63110, United States
  • University of New Mexico
    Albuquerque, New Mexico 87131, United States
  • Columbia University Medical Center
    New York, New York 10032, United States
  • Duke University School of Medicine
    Durham, North Carolina 27110, United States
  • North Carolina Clinical Research
    Raleigh, North Carolina 27607, United States
  • Wake Forest University Health Sciences
    Winston-Salem, North Carolina 27157, United States
  • Rainbow Babies and Children's Hospital, Case Western Reserve University
    Cleveland, Ohio 44106, United States
  • Allegheny General Hospital
    Pittsburgh, Pennsylvania 15212, United States
  • University of Pittsburgh
    Pittsburgh, Pennsylvania 15213, United States
  • Children's Hospital of Pittsburgh of UPMC
    Pittsburgh, Pennsylvania 15224, United States
  • University of Wisconsin-Madison
    Madison, Wisconsin 53792, United States
  • Center for Urban Population Health
    Milwaukee, Wisconsin 53223, United States
09

References and documents

Publications

  • Wechsler ME, Szefler SJ, Ortega VE, Pongracic JA, Chinchilli V, Lima JJ, Krishnan JA, Kunselman SJ, Mauger D, Bleecker ER, Bacharier LB, Beigelman A, Benson M, Blake KV, Cabana MD, Cardet JC, Castro M, Chmiel JF, Covar R, Denlinger L, DiMango E, Fitzpatrick AM, Gentile D, Grossman N, Holguin F, Jackson DJ, Kumar H, Kraft M, LaForce CF, Lang J, Lazarus SC, Lemanske RF Jr, Long D, Lugogo N, Martinez F, Meyers DA, Moore WC, Moy J, Naureckas E, Olin JT, Peters SP, Phipatanakul W, Que L, Raissy H, Robison RG, Ross K, Sheehan W, Smith LJ, Solway J, Sorkness CA, Sullivan-Vedder L, Wenzel S, White S, Israel E; NHLBI AsthmaNet. Step-Up Therapy in Black Children and Adults with Poorly Controlled Asthma. N Engl J Med. 2019 Sep 26;381(13):1227-1239. doi: 10.1056/NEJMoa1905560. PubMed 31553835 ↗

Related links

Study documents

  • Protocol and statistical analysis plan · Jul 21, 2017

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 15, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01967173
Lead sponsor
Milton S. Hershey Medical Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
dave mauger (Principal Investigator, AsthmaNet Data Coordinating Center, Milton S. Hershey Medical Center) — Principal investigator
First posted
Oct 22, 2013
Start date
Feb 2014
Primary completion
Jul 1, 2017
Completion
Jul 1, 2017
Results posted
Nov 15, 2018
Last update
Nov 15, 2018

Study contacts

William Busse, MD
study chair · University of Wisconsin, Madison

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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