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Mometasone or Tiotropium in Mild Asthma with a Low Sputum Eosinophil Level.

Publication ,  Journal Article
Lazarus, SC; Krishnan, JA; King, TS; Lang, JE; Blake, KV; Covar, R; Lugogo, N; Wenzel, S; Chinchilli, VM; Mauger, DT; Dyer, A-M; Boushey, HA ...
Published in: N Engl J Med
May 23, 2019

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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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

May 23, 2019

Volume

380

Issue

21

Start / End Page

2009 / 2019

Location

United States

Related Subject Headings

  • Young Adult
  • Tiotropium Bromide
  • Sputum
  • Mometasone Furoate
  • Middle Aged
  • Medication Adherence
  • Male
  • Leukocyte Count
  • Humans
  • Glucocorticoids
 

Citation

APA
Chicago
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Lazarus, S. C., Krishnan, J. A., King, T. S., Lang, J. E., Blake, K. V., Covar, R., … National Heart, Lung, and Blood Institute AsthmaNet, . (2019). Mometasone or Tiotropium in Mild Asthma with a Low Sputum Eosinophil Level. N Engl J Med, 380(21), 2009–2019. https://doi.org/10.1056/NEJMoa1814917
Lazarus, Stephen C., Jerry A. Krishnan, Tonya S. King, Jason E. Lang, Kathryn V. Blake, Ronina Covar, Njira Lugogo, et al. “Mometasone or Tiotropium in Mild Asthma with a Low Sputum Eosinophil Level.N Engl J Med 380, no. 21 (May 23, 2019): 2009–19. https://doi.org/10.1056/NEJMoa1814917.
Lazarus SC, Krishnan JA, King TS, Lang JE, Blake KV, Covar R, et al. Mometasone or Tiotropium in Mild Asthma with a Low Sputum Eosinophil Level. N Engl J Med. 2019 May 23;380(21):2009–19.
Lazarus, Stephen C., et al. “Mometasone or Tiotropium in Mild Asthma with a Low Sputum Eosinophil Level.N Engl J Med, vol. 380, no. 21, May 2019, pp. 2009–19. Pubmed, doi:10.1056/NEJMoa1814917.
Lazarus SC, Krishnan JA, King TS, Lang JE, Blake KV, Covar R, Lugogo N, Wenzel S, Chinchilli VM, Mauger DT, Dyer A-M, Boushey HA, Fahy JV, Woodruff PG, Bacharier LB, Cabana MD, Cardet JC, Castro M, Chmiel J, Denlinger L, DiMango E, Fitzpatrick AM, Gentile D, Hastie A, Holguin F, Israel E, Jackson D, Kraft M, LaForce C, Lemanske RF, Martinez FD, Moore W, Morgan WJ, Moy JN, Myers R, Peters SP, Phipatanakul W, Pongracic JA, Que L, Ross K, Smith L, Szefler SJ, Wechsler ME, Sorkness CA, National Heart, Lung, and Blood Institute AsthmaNet. Mometasone or Tiotropium in Mild Asthma with a Low Sputum Eosinophil Level. N Engl J Med. 2019 May 23;380(21):2009–2019.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

May 23, 2019

Volume

380

Issue

21

Start / End Page

2009 / 2019

Location

United States

Related Subject Headings

  • Young Adult
  • Tiotropium Bromide
  • Sputum
  • Mometasone Furoate
  • Middle Aged
  • Medication Adherence
  • Male
  • Leukocyte Count
  • Humans
  • Glucocorticoids