Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (LOGOS)
Summary
This is a variable length study to evaluate the efficacy and safety of budesonide/glycopyrronium/formoterol inhaler in adults and adolescents with severe asthma inadequately controlled with standard of care.
Timeline
- Start
- 2021-03-01
- Primary completion
- 2025-03-20
- Completion
- 2025-03-20
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
registry BGF MDI 320/14.4/9.6 μg BID vs BFF MDI 320/9.6 μg BID; p <0.001; LS Mean Difference 0.155 reads as mixed primary results NCT04609904 ↗
registry BGF MDI 320/14.4/9.6 μg BID vs BFF MDI 320/9.6 μg BID; p = 0.120; Rate ratio 0.882 (95% CI 0.754 to 1.033) reads as mixed primary results NCT04609904 ↗
release “LOGOS trials in patients with uncontrolled asthma showed that AstraZeneca’s fixed-dose triple-combination therapy Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF (320/28.8/9.6μg)) met all primary endpoints” reads as met primary endpoint astrazeneca.com ↗
Publications
- Papi A, Wise RA, Jackson DJ, Lugogo N, Chen R, Trasieva T, Obasi C, Movitz C, Helman J, Salter P, Springer K, Bondoc M, Shah M, Knappenberger K, Bowen K, Pandya H, Megally A, Patel M; KALOS and LOGOS study investigators. Budesonide-glycopyrronium-formoterol fumarate dihydrate in uncontrolled asthma (KALOS and LOGOS): twin multicentre, double-blind, double-dummy, parallel-group, randomised, phase 3 trials. Lancet Respir Med. 2026 Apr;14(4):350-362. doi: 10.1016/S2213-2600(25)00457-6. Epub 2026 Feb 12.
- Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Budesonide | Small molecule | 320 ug | Inhaled |
| Subject | Formoterol | Other / unclassified | 9 ug | Inhaled |
| Subject | Formoterol | Other / unclassified | 9.6 ug | Inhaled |
| Subject | Glycopyrronium | Unknown | 14.4 ug | Inhaled |
| Subject | Glycopyrronium | Unknown | 28.8 ug | Inhaled |