Best African American Response to Asthma Drugs



Status:Completed
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:5 - Any
Updated:11/17/2018
Start Date:February 2014
End Date:July 1, 2017

Use our guide to learn which trials are right for you!

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.

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.

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:

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.
We found this trial at
28
sites
Albuquerque, New Mexico 87131
(505) 277-0111
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Boston, MA
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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Cleveland, OH
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807 Childrens Way
Jacksonville, Florida 32207
(904) 697-3600
Nemours Children's Clinic At Nemours Children’s Clinic, Jacksonville, we've treated every child as we would...
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Jacksonville, FL
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747 52nd St
Oakland, California 94609
(510) 428-3000
Children's Hospital and Research Center Oakland For nearly 100 years, Children's Hospital & Research Center...
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Oakland, CA
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
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Pittsburgh, PA
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Boston, Massachusetts 02115
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Boston, MA
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Chicago, IL
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251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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Chicago, IL
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chicago, IL
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2035 W Taylor St
Chicago, Illinois
(312) 996-4350
University of Illinois at Chicago A major research university in the heart of one of...
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Chicago, IL
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1400 Jackson St
Denver, Colorado 80206
(303) 388-4461
National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
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Denver, CO
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Durham, North Carolina 27710
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Durham, NC
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Madison, Wisconsin 53706
(608) 263-2400
University of Wisconsin-Madison In achievement and prestige, the University of Wisconsin-Madison has long been recognized...
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Madison, WI
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Milwaukee, Wisconsin 53223
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Milwaukee, WI
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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New York, NY
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Orlando, Florida 32806
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Orlando, FL
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320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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Pittsburgh, PA
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Raleigh, North Carolina 27607
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Raleigh, NC
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Saint Louis, Missouri 63110
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Saint Louis, MO
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Saint Louis, Missouri 63110
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Saint Louis, MO
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San Francisco, California 94143
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San Francisco, CA
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San Francisco, California 94143
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Tucson, AZ
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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Winston-Salem, NC
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