Mometasone or Tiotropium in Mild Asthma with a Low Sputum Eosinophil Level.
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| 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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| Authors | Stephen C Lazarus, Jerry A Krishnan, Tonya S King, Jason E Lang, Kathryn V Blake, Ronina Covar, Njira Lugogo, Sally Wenzel, Vernon M Chinchilli, David T Mauger, Anne-Marie Dyer, Homer A Boushey, John V Fahy, Prescott G Woodruff, Leonard B Bacharier, Michael D Cabana, Juan C Cardet, Mario Castro, James Chmiel, Loren Denlinger, Emily DiMango, Anne M Fitzpatrick, Deborah Gentile, Annette Hastie, Fernando Holguin, Elliot Israel, Daniel Jackson, Monica Kraft, Craig LaForce, Robert F Lemanske Jr, Fernando D Martinez, Wendy Moore, Wayne J Morgan, James N Moy, Ross Myers, Stephen P Peters, Wanda Phipatanakul, Jacqueline A Pongracic, Loretta Que, Kristie Ross, Lewis Smith, Stanley J Szefler, Michael E Wechsler, Christine A Sorkness, National Heart, Lung, and Blood Institute AsthmaNet |
| Journal | The New England journal of medicine (N Engl J Med) Vol. 380 Issue 21 Pg. 2009-2019 (05 23 2019) ISSN: 1533-4406 [Electronic] United States |
| PMID | 31112384 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural) |
| Copyright | Copyright © 2019 Massachusetts Medical Society. |
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