drugset / Trial / NCT01430403
Preventative Omalizumab or Step-up Therapy for Severe Fall Exacerbations
Phase 4
Completed
478 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Inner-City Asthma Consortium · collab
RandomizedFactorialQuadruple-blindTreatment
Summary
The purpose of this trial is to compare the efficacy of 4 to 5 months of three treatments - omalizumab, corticosteroid therapy boost, and placebo - in reducing fall exacerbations in inner-city children and adolescents with allergic persistent asthma when initiated approximately 4 -6 weeks prior to the start of the first day of each participant's school year.
Timeline
- Start
- 2011-09
- Primary completion
- 2013-12
- Completion
- 2014-03
Outcome
Mixed primary results
registry Treatment Steps 2-5: Omalizumab vs Treatment Steps 2-5: Placebo; p = 0.03; Odds Ratio (OR) 0.48 (95% CI 0.25 to 0.92); Odds Ratio NCT01430403 ↗
registry Treatment Steps 2-4: Omalizumab vs Treatment Steps 2-4:Inhaled Corticosteroid Boost Therapy (ICS); p = 0.45; Odds Ratio (OR) 0.73 (95% CI 0.33 to 1.64); Odds Ratio NCT01430403 ↗
Publications
- Results Teach SJ, Gill MA, Togias A, Sorkness CA, Arbes SJ Jr, Calatroni A, Wildfire JJ, Gergen PJ, Cohen RT, Pongracic JA, Kercsmar CM, Khurana Hershey GK, Gruchalla RS, Liu AH, Zoratti EM, Kattan M, Grindle KA, Gern JE, Busse WW, Szefler SJ. Preseasonal treatment with either omalizumab or an inhaled corticosteroid boost to prevent fall asthma exacerbations. J Allergy Clin Immunol. 2015 Dec;136(6):1476-1485. doi: 10.1016/j.jaci.2015.09.008. Epub 2015 Oct 27.
- Szefler SJ, Casale TB, Haselkorn T, Yoo B, Ortiz B, Kattan M, Busse WW. Treatment Benefit with Omalizumab in Children by Indicators of Asthma Severity. J Allergy Clin Immunol Pract. 2020 Sep;8(8):2673-2680.e3. doi: 10.1016/j.jaip.2020.03.033. Epub 2020 Apr 13.
- Esquivel A, Busse WW, Calatroni A, Togias AG, Grindle KG, Bochkov YA, Gruchalla RS, Kattan M, Kercsmar CM, Khurana Hershey G, Kim H, Lebeau P, Liu AH, Szefler SJ, Teach SJ, West JB, Wildfire J, Pongracic JA, Gern JE. Effects of Omalizumab on Rhinovirus Infections, Illnesses, and Exacerbations of Asthma. Am J Respir Crit Care Med. 2017 Oct 15;196(8):985-992. doi: 10.1164/rccm.201701-0120OC.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fluticasone | Other / unclassified | 200 ug | Inhaled |
| Subject | Fluticasone | Other / unclassified | 500 ug | Inhaled |
| Subject | Omalizumab | Monoclonal antibody | 0.016 unknown | Subcutaneous |