Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (KALOS)
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
- 2020-12-15
- Primary completion
- 2025-03-21
- Completion
- 2025-03-21
Outcome
Mixed primary results
registry analysis (superiority test); BGF MDI 320/28.8/9.6 μg BID vs BFF MDI 320/9.6 μg BID; p <0.001; LS Mean Difference 0.068 (95% CI 0.029 to 0.106); ANCOVA NCT04609878 ↗
registry analysis (superiority test); BGF MDI 320/14.4/9.6 μg BID vs BFF MDI 320/9.6 μg BID; p = 0.168; LS Mean Difference 0.032 (95% CI -0.013 to 0.077); ANCOVA NCT04609878 ↗
registry analysis (superiority test); BGF MDI 320/28.8/9.6 μg BID vs BFF MDI 320/9.6 μg BID; p = 0.124; Rate ratio 0.896 (95% CI 0.779 to 1.031); Negative binomial regression NCT04609878 ↗
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 | 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 |
| Background | Budesonide | Small molecule | 320 ug | Inhaled |