drugset / Trial / NCT06272370
Individualizing Treatment for Asthma in Primary Care
Phase 4
Completed
103 enrolled
DARTNet Institute
Brigham and Women's Hospital · collabIcahn School of Medicine at Mount Sinai · collabKelsey Research Foundation · collabPenn State University · collabRAND · collabReliant Medical Group · collabRutgers University · collabUniversity of Colorado, Denver · collabUniversity of North Carolina · collabUniversity of Washington · collabWake Forest University Health Sciences · collab
RandomizedParallel-groupOpen-labelHealth-services research
Summary
This is a patient level randomized trial for teenagers and adults with asthma who will be randomized to four arms - enhance usual care, rescue inhaled corticosteroids, azithromycin and both rescue inhaled corticosteroids and azithromycin. Participants in all arms will be offered access to an online asthma symptom monitoring system.
Timeline
- Start
- 2024-02-01
- Primary completion
- 2024-09-30
- Completion
- 2024-12-31
Publications
- Background Israel E, Cardet JC, Carroll JK, Fuhlbrigge AL, She L, Rockhold FW, Maher NE, Fagan M, Forth VE, Yawn BP, Arias Hernandez P, Kruse JM, Manning BK, Rodriguez-Louis J, Shields JB, Ericson B, Colon-Moya AD, Madison S, Coyne-Beasley T, Hammer GM, Kaplan BM, Rand CS, Robles J, Thompson O, Wechsler ME, Wisnivesky JP, McKee MD, Jariwala SP, Jerschow E, Busse PJ, Kaelber DC, Nazario S, Hernandez ML, Apter AJ, Chang KL, Pinto-Plata V, Stranges PM, Hurley LP, Trevor J, Casale TB, Chupp G, Riley IL, Shenoy K, Pasarica M, Calderon-Candelario RA, Tapp H, Baydur A, Pace WD. Reliever-Triggered Inhaled Glucocorticoid in Black and Latinx Adults with Asthma. N Engl J Med. 2022 Apr 21;386(16):1505-1518. doi: 10.1056/NEJMoa2118813. Epub 2022 Feb 26.
- Background Ray A, Camiolo M, Fitzpatrick A, Gauthier M, Wenzel SE. Are We Meeting the Promise of Endotypes and Precision Medicine in Asthma? Physiol Rev. 2020 Jul 1;100(3):983-1017. doi: 10.1152/physrev.00023.2019. Epub 2020 Jan 9.
- Background Wenzel SE. Severe Adult Asthmas: Integrating Clinical Features, Biology, and Therapeutics to Improve Outcomes. Am J Respir Crit Care Med. 2021 Apr 1;203(7):809-821. doi: 10.1164/rccm.202009-3631CI.
- Background Calmes D, Huynen P, Paulus V, Henket M, Guissard F, Moermans C, Louis R, Schleich F. Chronic infection with Chlamydia pneumoniae in asthma: a type-2 low infection related phenotype. Respir Res. 2021 Feb 26;22(1):72. doi: 10.1186/s12931-021-01635-w.
- Background Global Initiative for Asthma. Global strategy for asthma management and prevention 2023 report. Accessed February 10, 2024. https://ginasthma.org/2023-gina-main-report/
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Azithromycin | Small molecule | 10 mg/kg | — |
| Comparator | Azithromycin | Small molecule | 250 mg | — |
| Comparator | Azithromycin | Small molecule | 250 mg/kg | — |
| Comparator | Azithromycin | Small molecule | 500 mg | — |
| Comparator | Beclomethasone | Small molecule | — | — |
| Comparator | Budesonide | Small molecule | — | — |
| Comparator | Fluticasone | Other / unclassified | — | — |
| Comparator | Formoterol | Other / unclassified | — | — |
| Comparator | Mometasone | Other / unclassified | — | — |
| Comparator | Salbutamol | Unknown | — | — |
| Comparator | ciclesodine | Unknown | — | — |