Best African American Response to Asthma Drugs
Condition: Asthma
MeSH terms: Asthma
Intervention: Flovent Diskus® 100 mcg; Flovent Diskus® 250 mcg; Flovent Diskus® 500 mcg; Advair Diskus® 100/50 mcg; Advair Diskus® 250/50 mcg
Intervention description: Flovent is an ICS; Flovent is an ICS; Flovent is an ICS; Advair is an ICS/LABA combination; Advair is an ICS/LABA combination
Intervention MeSH terms: Fluticasone; Xhance; Fluticasone-Salmeterol Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 574.0
Sex: All
Minimum age: 5 Years
Healthy volunteers: No
Keywords: Asthma; Fluticasone; Salmeterol

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.
    

Eligibility criteria:

        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.