Best African American Response to Asthma Drugs

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.