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Mometasone or Tiotropium in Mild Asthma with a Low Sputum Eosinophil Level.
Lazarus, Stephen C; Krishnan, Jerry A; King, Tonya S; Lang, Jason E; Blake, Kathryn V; Covar, Ronina; Lugogo, Njira; Wenzel, Sally; Chinchilli, Vernon M; Mauger, David T; Dyer, Anne-Marie; Boushey, Homer A; Fahy, John V; Woodruff, Prescott G; Bacharier, Leonard B; Cabana, Michael D; Cardet, Juan C; Castro, Mario; Chmiel, James; Denlinger, Loren; DiMango, Emily; Fitzpatrick, Anne M; Gentile, Deborah; Hastie, Annette; Holguin, Fernando; Israel, Elliot; Jackson, Daniel; Kraft, Monica; LaForce, Craig; Lemanske, Robert F; Martinez, Fernando D; Moore, Wendy; Morgan, Wayne J; Moy, James N; Myers, Ross; Peters, Stephen P; Phipatanakul, Wanda; Pongracic, Jacqueline A; Que, Loretta; Ross, Kristie; Smith, Lewis; Szefler, Stanley J; Wechsler, Michael E; Sorkness, Christine A.
Afiliación
  • Lazarus SC; From the Division of Pulmonary and Critical Care Medicine and the Cardiovascular Research Institute (S.C.L., H.A.B., J.V.F., P.G.W.) and the Department of Pediatrics, Epidemiology, and Biostatistics (M.D.C.), University of California, San Francisco, San Francisco; the University of Illinois at Chica
  • Krishnan JA; From the Division of Pulmonary and Critical Care Medicine and the Cardiovascular Research Institute (S.C.L., H.A.B., J.V.F., P.G.W.) and the Department of Pediatrics, Epidemiology, and Biostatistics (M.D.C.), University of California, San Francisco, San Francisco; the University of Illinois at Chica
  • King TS; From the Division of Pulmonary and Critical Care Medicine and the Cardiovascular Research Institute (S.C.L., H.A.B., J.V.F., P.G.W.) and the Department of Pediatrics, Epidemiology, and Biostatistics (M.D.C.), University of California, San Francisco, San Francisco; the University of Illinois at Chica
  • Lang JE; From the Division of Pulmonary and Critical Care Medicine and the Cardiovascular Research Institute (S.C.L., H.A.B., J.V.F., P.G.W.) and the Department of Pediatrics, Epidemiology, and Biostatistics (M.D.C.), University of California, San Francisco, San Francisco; the University of Illinois at Chica
  • Blake KV; From the Division of Pulmonary and Critical Care Medicine and the Cardiovascular Research Institute (S.C.L., H.A.B., J.V.F., P.G.W.) and the Department of Pediatrics, Epidemiology, and Biostatistics (M.D.C.), University of California, San Francisco, San Francisco; the University of Illinois at Chica
  • Covar R; From the Division of Pulmonary and Critical Care Medicine and the Cardiovascular Research Institute (S.C.L., H.A.B., J.V.F., P.G.W.) and the Department of Pediatrics, Epidemiology, and Biostatistics (M.D.C.), University of California, San Francisco, San Francisco; the University of Illinois at Chica
  • Lugogo N; From the Division of Pulmonary and Critical Care Medicine and the Cardiovascular Research Institute (S.C.L., H.A.B., J.V.F., P.G.W.) and the Department of Pediatrics, Epidemiology, and Biostatistics (M.D.C.), University of California, San Francisco, San Francisco; the University of Illinois at Chica
  • Wenzel S; From the Division of Pulmonary and Critical Care Medicine and the Cardiovascular Research Institute (S.C.L., H.A.B., J.V.F., P.G.W.) and the Department of Pediatrics, Epidemiology, and Biostatistics (M.D.C.), University of California, San Francisco, San Francisco; the University of Illinois at Chica
  • Chinchilli VM; From the Division of Pulmonary and Critical Care Medicine and the Cardiovascular Research Institute (S.C.L., H.A.B., J.V.F., P.G.W.) and the Department of Pediatrics, Epidemiology, and Biostatistics (M.D.C.), University of California, San Francisco, San Francisco; the University of Illinois at Chica
  • Mauger DT; From the Division of Pulmonary and Critical Care Medicine and the Cardiovascular Research Institute (S.C.L., H.A.B., J.V.F., P.G.W.) and the Department of Pediatrics, Epidemiology, and Biostatistics (M.D.C.), University of California, San Francisco, San Francisco; the University of Illinois at Chica
  • Dyer AM; From the Division of Pulmonary and Critical Care Medicine and the Cardiovascular Research Institute (S.C.L., H.A.B., J.V.F., P.G.W.) and the Department of Pediatrics, Epidemiology, and Biostatistics (M.D.C.), University of California, San Francisco, San Francisco; the University of Illinois at Chica
  • Boushey HA; From the Division of Pulmonary and Critical Care Medicine and the Cardiovascular Research Institute (S.C.L., H.A.B., J.V.F., P.G.W.) and the Department of Pediatrics, Epidemiology, and Biostatistics (M.D.C.), University of California, San Francisco, San Francisco; the University of Illinois at Chica
  • Fahy JV; From the Division of Pulmonary and Critical Care Medicine and the Cardiovascular Research Institute (S.C.L., H.A.B., J.V.F., P.G.W.) and the Department of Pediatrics, Epidemiology, and Biostatistics (M.D.C.), University of California, San Francisco, San Francisco; the University of Illinois at Chica
  • Woodruff PG; From the Division of Pulmonary and Critical Care Medicine and the Cardiovascular Research Institute (S.C.L., H.A.B., J.V.F., P.G.W.) and the Department of Pediatrics, Epidemiology, and Biostatistics (M.D.C.), University of California, San Francisco, San Francisco; the University of Illinois at Chica
  • Bacharier LB; From the Division of Pulmonary and Critical Care Medicine and the Cardiovascular Research Institute (S.C.L., H.A.B., J.V.F., P.G.W.) and the Department of Pediatrics, Epidemiology, and Biostatistics (M.D.C.), University of California, San Francisco, San Francisco; the University of Illinois at Chica
  • Cabana MD; From the Division of Pulmonary and Critical Care Medicine and the Cardiovascular Research Institute (S.C.L., H.A.B., J.V.F., P.G.W.) and the Department of Pediatrics, Epidemiology, and Biostatistics (M.D.C.), University of California, San Francisco, San Francisco; the University of Illinois at Chica
  • Cardet JC; From the Division of Pulmonary and Critical Care Medicine and the Cardiovascular Research Institute (S.C.L., H.A.B., J.V.F., P.G.W.) and the Department of Pediatrics, Epidemiology, and Biostatistics (M.D.C.), University of California, San Francisco, San Francisco; the University of Illinois at Chica
  • Castro M; From the Division of Pulmonary and Critical Care Medicine and the Cardiovascular Research Institute (S.C.L., H.A.B., J.V.F., P.G.W.) and the Department of Pediatrics, Epidemiology, and Biostatistics (M.D.C.), University of California, San Francisco, San Francisco; the University of Illinois at Chica
  • Chmiel J; From the Division of Pulmonary and Critical Care Medicine and the Cardiovascular Research Institute (S.C.L., H.A.B., J.V.F., P.G.W.) and the Department of Pediatrics, Epidemiology, and Biostatistics (M.D.C.), University of California, San Francisco, San Francisco; the University of Illinois at Chica
  • Denlinger L; From the Division of Pulmonary and Critical Care Medicine and the Cardiovascular Research Institute (S.C.L., H.A.B., J.V.F., P.G.W.) and the Department of Pediatrics, Epidemiology, and Biostatistics (M.D.C.), University of California, San Francisco, San Francisco; the University of Illinois at Chica
  • DiMango E; From the Division of Pulmonary and Critical Care Medicine and the Cardiovascular Research Institute (S.C.L., H.A.B., J.V.F., P.G.W.) and the Department of Pediatrics, Epidemiology, and Biostatistics (M.D.C.), University of California, San Francisco, San Francisco; the University of Illinois at Chica
  • Fitzpatrick AM; From the Division of Pulmonary and Critical Care Medicine and the Cardiovascular Research Institute (S.C.L., H.A.B., J.V.F., P.G.W.) and the Department of Pediatrics, Epidemiology, and Biostatistics (M.D.C.), University of California, San Francisco, San Francisco; the University of Illinois at Chica
  • Gentile D; From the Division of Pulmonary and Critical Care Medicine and the Cardiovascular Research Institute (S.C.L., H.A.B., J.V.F., P.G.W.) and the Department of Pediatrics, Epidemiology, and Biostatistics (M.D.C.), University of California, San Francisco, San Francisco; the University of Illinois at Chica
  • Hastie A; From the Division of Pulmonary and Critical Care Medicine and the Cardiovascular Research Institute (S.C.L., H.A.B., J.V.F., P.G.W.) and the Department of Pediatrics, Epidemiology, and Biostatistics (M.D.C.), University of California, San Francisco, San Francisco; the University of Illinois at Chica
  • Holguin F; From the Division of Pulmonary and Critical Care Medicine and the Cardiovascular Research Institute (S.C.L., H.A.B., J.V.F., P.G.W.) and the Department of Pediatrics, Epidemiology, and Biostatistics (M.D.C.), University of California, San Francisco, San Francisco; the University of Illinois at Chica
  • Israel E; From the Division of Pulmonary and Critical Care Medicine and the Cardiovascular Research Institute (S.C.L., H.A.B., J.V.F., P.G.W.) and the Department of Pediatrics, Epidemiology, and Biostatistics (M.D.C.), University of California, San Francisco, San Francisco; the University of Illinois at Chica
  • Jackson D; From the Division of Pulmonary and Critical Care Medicine and the Cardiovascular Research Institute (S.C.L., H.A.B., J.V.F., P.G.W.) and the Department of Pediatrics, Epidemiology, and Biostatistics (M.D.C.), University of California, San Francisco, San Francisco; the University of Illinois at Chica
  • Kraft M; From the Division of Pulmonary and Critical Care Medicine and the Cardiovascular Research Institute (S.C.L., H.A.B., J.V.F., P.G.W.) and the Department of Pediatrics, Epidemiology, and Biostatistics (M.D.C.), University of California, San Francisco, San Francisco; the University of Illinois at Chica
  • LaForce C; From the Division of Pulmonary and Critical Care Medicine and the Cardiovascular Research Institute (S.C.L., H.A.B., J.V.F., P.G.W.) and the Department of Pediatrics, Epidemiology, and Biostatistics (M.D.C.), University of California, San Francisco, San Francisco; the University of Illinois at Chica
  • Lemanske RF; From the Division of Pulmonary and Critical Care Medicine and the Cardiovascular Research Institute (S.C.L., H.A.B., J.V.F., P.G.W.) and the Department of Pediatrics, Epidemiology, and Biostatistics (M.D.C.), University of California, San Francisco, San Francisco; the University of Illinois at Chica
  • Martinez FD; From the Division of Pulmonary and Critical Care Medicine and the Cardiovascular Research Institute (S.C.L., H.A.B., J.V.F., P.G.W.) and the Department of Pediatrics, Epidemiology, and Biostatistics (M.D.C.), University of California, San Francisco, San Francisco; the University of Illinois at Chica
  • Moore W; From the Division of Pulmonary and Critical Care Medicine and the Cardiovascular Research Institute (S.C.L., H.A.B., J.V.F., P.G.W.) and the Department of Pediatrics, Epidemiology, and Biostatistics (M.D.C.), University of California, San Francisco, San Francisco; the University of Illinois at Chica
  • Morgan WJ; From the Division of Pulmonary and Critical Care Medicine and the Cardiovascular Research Institute (S.C.L., H.A.B., J.V.F., P.G.W.) and the Department of Pediatrics, Epidemiology, and Biostatistics (M.D.C.), University of California, San Francisco, San Francisco; the University of Illinois at Chica
  • Moy JN; From the Division of Pulmonary and Critical Care Medicine and the Cardiovascular Research Institute (S.C.L., H.A.B., J.V.F., P.G.W.) and the Department of Pediatrics, Epidemiology, and Biostatistics (M.D.C.), University of California, San Francisco, San Francisco; the University of Illinois at Chica
  • Myers R; From the Division of Pulmonary and Critical Care Medicine and the Cardiovascular Research Institute (S.C.L., H.A.B., J.V.F., P.G.W.) and the Department of Pediatrics, Epidemiology, and Biostatistics (M.D.C.), University of California, San Francisco, San Francisco; the University of Illinois at Chica
  • Peters SP; From the Division of Pulmonary and Critical Care Medicine and the Cardiovascular Research Institute (S.C.L., H.A.B., J.V.F., P.G.W.) and the Department of Pediatrics, Epidemiology, and Biostatistics (M.D.C.), University of California, San Francisco, San Francisco; the University of Illinois at Chica
  • Phipatanakul W; From the Division of Pulmonary and Critical Care Medicine and the Cardiovascular Research Institute (S.C.L., H.A.B., J.V.F., P.G.W.) and the Department of Pediatrics, Epidemiology, and Biostatistics (M.D.C.), University of California, San Francisco, San Francisco; the University of Illinois at Chica
  • Pongracic JA; From the Division of Pulmonary and Critical Care Medicine and the Cardiovascular Research Institute (S.C.L., H.A.B., J.V.F., P.G.W.) and the Department of Pediatrics, Epidemiology, and Biostatistics (M.D.C.), University of California, San Francisco, San Francisco; the University of Illinois at Chica
  • Que L; From the Division of Pulmonary and Critical Care Medicine and the Cardiovascular Research Institute (S.C.L., H.A.B., J.V.F., P.G.W.) and the Department of Pediatrics, Epidemiology, and Biostatistics (M.D.C.), University of California, San Francisco, San Francisco; the University of Illinois at Chica
  • Ross K; From the Division of Pulmonary and Critical Care Medicine and the Cardiovascular Research Institute (S.C.L., H.A.B., J.V.F., P.G.W.) and the Department of Pediatrics, Epidemiology, and Biostatistics (M.D.C.), University of California, San Francisco, San Francisco; the University of Illinois at Chica
  • Smith L; From the Division of Pulmonary and Critical Care Medicine and the Cardiovascular Research Institute (S.C.L., H.A.B., J.V.F., P.G.W.) and the Department of Pediatrics, Epidemiology, and Biostatistics (M.D.C.), University of California, San Francisco, San Francisco; the University of Illinois at Chica
  • Szefler SJ; From the Division of Pulmonary and Critical Care Medicine and the Cardiovascular Research Institute (S.C.L., H.A.B., J.V.F., P.G.W.) and the Department of Pediatrics, Epidemiology, and Biostatistics (M.D.C.), University of California, San Francisco, San Francisco; the University of Illinois at Chica
  • Wechsler ME; From the Division of Pulmonary and Critical Care Medicine and the Cardiovascular Research Institute (S.C.L., H.A.B., J.V.F., P.G.W.) and the Department of Pediatrics, Epidemiology, and Biostatistics (M.D.C.), University of California, San Francisco, San Francisco; the University of Illinois at Chica
  • Sorkness CA; From the Division of Pulmonary and Critical Care Medicine and the Cardiovascular Research Institute (S.C.L., H.A.B., J.V.F., P.G.W.) and the Department of Pediatrics, Epidemiology, and Biostatistics (M.D.C.), University of California, San Francisco, San Francisco; the University of Illinois at Chica
N Engl J Med ; 380(21): 2009-2019, 2019 05 23.
Article en En | MEDLINE | ID: mdl-31112384
ABSTRACT

BACKGROUND:

In many patients with mild, persistent asthma, the percentage of eosinophils in sputum is less than 2% (low eosinophil level). The appropriate treatment for these patients is unknown.

METHODS:

In this 42-week, double-blind, crossover trial, we assigned 295 patients who were at least 12 years of age and who had mild, persistent asthma to receive mometasone (an inhaled glucocorticoid), tiotropium (a long-acting muscarinic antagonist), or placebo. The patients were categorized according to the sputum eosinophil level (<2% or ≥2%). The primary outcome was the response to mometasone as compared with placebo and to tiotropium as compared with placebo among patients with a low sputum eosinophil level who had a prespecified differential response to one of the trial agents. The response was determined according to a hierarchical composite outcome that incorporated treatment failure, asthma control days, and the forced expiratory volume in 1 second; a two-sided P value of less than 0.025 denoted statistical significance. A secondary outcome was a comparison of results in patients with a high sputum eosinophil level and those with a low level.

RESULTS:

A total of 73% of the patients had a low eosinophil level; of these patients, 59% had a differential response to a trial agent. However, there was no significant difference in the response to mometasone or tiotropium, as compared with placebo. Among the patients with a low eosinophil level who had a differential treatment response, 57% (95% confidence interval [CI], 48 to 66) had a better response to mometasone, and 43% (95% CI, 34 to 52) had a better response to placebo (P = 0.14). In contrast 60% (95% CI, 51 to 68) had a better response to tiotropium, whereas 40% (95% CI, 32 to 49) had a better response to placebo (P = 0.029). Among patients with a high eosinophil level, the response to mometasone was significantly better than the response to placebo (74% vs. 26%) but the response to tiotropium was not (57% vs. 43%).

CONCLUSIONS:

The majority of patients with mild, persistent asthma had a low sputum eosinophil level and had no significant difference in their response to either mometasone or tiotropium as compared with placebo. These data provide equipoise for a clinically directive trial to compare an inhaled glucocorticoid with other treatments in patients with a low eosinophil level. (Funded by the National Heart, Lung, and Blood Institute; SIENA ClinicalTrials.gov number, NCT02066298.).
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Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Asma / Esputo / Broncodilatadores / Eosinófilos / Bromuro de Tiotropio / Furoato de Mometasona / Glucocorticoides Tipo de estudio: Clinical_trials / Guideline Límite: Adolescent / Adult / Female / Humans / Male / Middle aged Idioma: En Año: 2019 Tipo del documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Asma / Esputo / Broncodilatadores / Eosinófilos / Bromuro de Tiotropio / Furoato de Mometasona / Glucocorticoides Tipo de estudio: Clinical_trials / Guideline Límite: Adolescent / Adult / Female / Humans / Male / Middle aged Idioma: En Año: 2019 Tipo del documento: Article