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Step-Up Therapy in Black Children and Adults with Poorly Controlled Asthma
Michael E Wechsler1, Stanley J Szefler1, Victor E Ortega1
1From National Jewish Health (M.E.W., R.C., J.T.O.), Denver, and University of Colorado School of Medicine (M.E.W., S.J.S., R.C., F.H., J.T.O.) and Children's Hospital Colorado (S.J.S.), Aurora - all in Colorado; Wake Forest School of Medicine (V.E.O., W.C.M., S.P.P.), Winston-Salem, North Carolina Clinical Research (C.F.L.), Raleigh, and Duke University Medical Center (N.L., L.Q.), Durham - all in North Carolina; Ann and Robert H. Lurie Children's Hospital of Chicago (J.A.P., R.G.R.), University of Illinois at Chicago (J.A.K., H.K.), Rush University Medical Center (J.M.), University of Chicago (E.N., J.S., S. White), and Northwestern University Feinberg School of Medicine (L.J.S.) - all in Chicago; Penn State University (V.C., S.J.K., D.M.), Hershey, and Allegheny General Hospital (D.G.) and University of Pittsburgh Medical Center (S. Wenzel), Pittsburgh - all in Pennsylvania; Nemours Children's Health System, Jacksonville (J.J.L., K.V.B., J.L.), and University of South Florida Morsani College of Medicine, Tampa (J.-C.C.) - both in Florida; University of Arizona Health Sciences, Tucson (E.R.B., M.K., F.M., D.A.M.); Washington University School of Medicine, St. Louis (L.B.B., A.B., M.C.); University of California, San Francisco (UCSF), San Francisco (M.B., M.D.C., S.C.L., D.L.) and UCSF Benioff Children's Hospital, Oakland (M.B., D.L.) - both in California; Brigham and Women's Hospital and Harvard Medical School (J.-C.C., N.G., E.I.) and Boston Children's Hospital (W.P., W.S.) - all in Boston; University Hospitals Rainbow Babies and Children's Hospital, Case Western Reserve University School of Medicine, Cleveland (J.F.C., K.R.); University of Wisconsin-Madison, Madison (L.D., D.J.J., R.F.L., C.A.S.) and Aurora Sinai Medical Center, Milwaukee (L.S.-V.) - both in Wisconsin; Columbia University Irving Medical Center, New York, (E.D.); Emory University, Atlanta (A.M.F.); and University of New Mexico, Albuquerque (H.R.).
Background:
Morbidity from asthma is disproportionately higher among black patients than among white patients, and black patients constitute the minority of participants in trials informing treatment. Data indicate that patients with inadequately controlled asthma benefit more from addition of a long-acting beta-agonist (LABA) than from increased glucocorticoids; however, these data may not be informative for treatment in black patients.
Methods:
We conducted two prospective, randomized, double-blind trials: one involving children and the other involving adolescents and adults. In both trials, the patients had at least one grandparent who identified as black and had asthma that was inadequately controlled with low-dose inhaled glucocorticoids. We compared combinations of therapy, which included the addition of a LABA (salmeterol) to an inhaled glucocorticoid (fluticasone propionate), a step-up to double to quintuple the dose of fluticasone, or both. The treatments were compared with the use of a composite measure that evaluated asthma exacerbations, asthma-control days, and lung function; data were stratified according to genotypic African ancestry.
Results:
When quintupling the dose of fluticasone (to 250 μg twice a day) was compared with adding salmeterol (50 μg twice a day) and doubling the fluticasone (to 100 μg twice a day), a superior response occurred in 46% of the children with quintupling the fluticasone and in 46% of the children with doubling the fluticasone and adding salmeterol (P = 0.99). In contrast, more adolescents and adults had a superior response to added salmeterol than to an increase in fluticasone (salmeterol-low-dose fluticasone vs. medium-dose fluticasone, 49% vs. 28% [P = 0.003]; salmeterol-medium-dose fluticasone vs. high-dose fluticasone, 49% vs. 31% [P = 0.02]). Neither the degree of African ancestry nor baseline biomarkers predicted a superior response to specific treatments. The increased dose of inhaled glucocorticoids was associated with a decrease in the ratio of urinary cortisol to creatinine in children younger than 8 years of age.
Conclusions:
In contrast to black adolescents and adults, almost half the black children with poorly controlled asthma had a superior response to an increase in the dose of an inhaled glucocorticoid and almost half had a superior response to the addition of a LABA. (Funded by the National Heart, Lung, and Blood Institute; BARD ClinicalTrials.gov number, NCT01967173.).
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