drugset / Trial / NCT04589663
Study to Compare the Pharmacokinetics of Mometasone Furoate Alone and in Combination With Indacaterol in Patients ≥ 6 to < 12 Years Old With Asthma
NaSingle-groupOpen-labelTreatment
Summary
This clinical study was designed to assess the pharmacokinetics, safety and tolerability of single inhaled doses of mometasone furoate (MF) when administered alone via MF Twisthaler® (TH) or as an indacaterol acetate/MF fixed dose combination (QMF149) via the Concept 1 (C1) device in pediatric asthma patients.
Timeline
- Start
- 2021-06-07
- Primary completion
- 2022-04-11
- Completion
- 2022-04-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Indacaterol | Other / unclassified | 75 ug | Inhaled |
| Subject | Mometasone furoate | Other / unclassified | 40 ug | Inhaled |
| Subject | Mometasone furoate | Other / unclassified | 100 ug | Inhaled |
| Background | Budesonide | Small molecule | — | — |
| Background | Salbutamol | Unknown | — | — |