Steroids In Eosinophil Negative Asthma
Summary
Because approximately half of all mild-moderately-severe asthma is persistently non-eosinophilic, it is important to determine prospectively if patients who are persistently non-eosinophilic differ in their benefit from inhaled corticosteroid treatment compared to patients who are not persistently non-eosinophilic.
Timeline
- Start
- 2014-07
- Primary completion
- 2018-05
- Completion
- 2018-05
Outcome
Missed primary endpoint
paper However, there was no significant difference in the response to mometasone or tiotropium, as compared with placebo. PMID 31112384 ↗
registry analysis (superiority test); Eosinophil Low; p = 0.14; exact binomial test NCT02066298 ↗
registry analysis (superiority test); Eosinophil Low; p = 0.029; exact binomial test; note: a priori threshold for significance was 0.025 NCT02066298 ↗
Publications
- Covar R, Lazarus SC, Krishnan JA, Blake KV, Sorkness CA, Dyer AM, Lang JE, Lugogo NL, Mauger DT, Wechsler ME, Wenzel SE, Cardet JC, Castro M, Israel E, Phipatanakul W, King TS; National Heart, Lung, and Blood Institute AsthmaNet. Association of Sputum Eosinophilia With Easily Measured Type-2 Inflammatory Biomarkers in Untreated Mild Persistent Asthma. J Allergy Clin Immunol Pract. 2024 Apr;12(4):960-969.e6. doi: 10.1016/j.jaip.2023.12.010. Epub 2023 Dec 12.
- Lazarus SC, Krishnan JA, King TS, Lang JE, Blake KV, Covar R, Lugogo N, Wenzel S, Chinchilli VM, Mauger DT, Dyer AM, 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 Jr, 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. doi: 10.1056/NEJMoa1814917. Epub 2019 May 19.
- Sorkness CA, King TS, Dyer AM, Chinchilli VM, Mauger DT, Krishnan JA, Blake K, Castro M, Covar R, Israel E, Kraft M, Lang JE, Lugogo N, Peters SP, Wechsler ME, Wenzel SE, Lazarus SC; National Heart Lung and Blood Institute's "AsthmaNet". Adapting clinical trial design to maintain meaningful outcomes during a multicenter asthma trial in the precision medicine era. Contemp Clin Trials. 2019 Feb;77:98-103. doi: 10.1016/j.cct.2018.12.012. Epub 2018 Dec 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mometasone | Other / unclassified | 220 ug | Inhaled |
| Subject | Tiotropium | Other / unclassified | 5 ug | — |