drugset / Trial / NCT02066129
Step-up Yellow Zone Inhaled Corticosteroids to Prevent Exacerbations
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The objective of this study is to determine whether, in children receiving low-dose inhaled corticosteroids (ICS), quintupling the dose of inhaled corticosteroids at the onset of symptoms previously associated with upper respiratory illnesses and subsequent asthma exacerbations reduces the rate of severe asthma exacerbations treated with oral corticosteroids.
Timeline
- Start
- 2014-07
- Primary completion
- 2017-04-21
- Completion
- 2017-04-21
Publications
- Gomez LF, Kinnee E, Kaufman JD, Young MT, Fitzpatrick AM, Phipatanakul W, Mauger DT, McClure LA, Bilal U, Holguin F, Clougherty JE. Modification of asthma treatment efficacy by healthcare access: A reanalysis of AsthmaNet Step-Up Yellow Zone Inhaled Corticosteroids to Prevent Exacerbations (STICS) clinical trial. Respir Med. 2024 Nov-Dec;234:107853. doi: 10.1016/j.rmed.2024.107853. Epub 2024 Nov 5.
- Yuan H, Liu Z, Dong J, Bacharier LB, Jackson D, Mauger D, Boushey H, Castro M, Durack J, Huang YJ, Lemanske RF Jr, Storch GA, Weinstock GM, Wylie K, Covar R, Fitzpatrick AM, Phipatanakul W, Robison RG, Beigelman A, Zhou Y. The Fungal Microbiome of the Upper Airway Is Associated With Future Loss of Asthma Control and Exacerbation Among Children With Asthma. Chest. 2023 Aug;164(2):302-313. doi: 10.1016/j.chest.2023.03.034. Epub 2023 Mar 30.
- Jackson DJ, Bacharier LB, Mauger DT, Boehmer S, Beigelman A, Chmiel JF, Fitzpatrick AM, Gaffin JM, Morgan WJ, Peters SP, Phipatanakul W, Sheehan WJ, Cabana MD, Holguin F, Martinez FD, Pongracic JA, Baxi SN, Benson M, Blake K, Covar R, Gentile DA, Israel E, Krishnan JA, Kumar HV, Lang JE, Lazarus SC, Lima JJ, Long D, Ly N, Marbin J, Moy JN, Myers RE, Olin JT, Raissy HH, Robison RG, Ross K, Sorkness CA, Lemanske RF Jr; National Heart, Lung, and Blood Institute AsthmaNet. Quintupling Inhaled Glucocorticoids to Prevent Childhood Asthma Exacerbations. N Engl J Med. 2018 Mar 8;378(10):891-901. doi: 10.1056/NEJMoa1710988. Epub 2018 Mar 3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Fluticasone propionate | Other / unclassified | 44 ug | Inhaled |
| Comparator | Fluticasone propionate | Other / unclassified | 220 ug | Inhaled |