drugset / Trial / NCT03015259
Randomized, Placebo-controlled, Multi-dose, Study Comparing Budesonide/Formoterol to Symbicort® in Asthmatic Patients
RandomizedParallel-groupSingle-blindTreatment
Summary
A randomized multiple-dose, placebo-controlled, parallel group design consisting of a 2-week run-in period followed by a 6-week treatment period of the placebo, Test product (Budesonide 80 mcg / Formoterol fumarate dihydrate 4.5 mcg), or Reference product Symbicort® inhalation aerosol.
Timeline
- Start
- 2016-12-29
- Primary completion
- 2018-02-08
- Completion
- 2018-02-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Budesonide | Small molecule | 0.08 mg | Inhaled |
| Subject | Formoterol | Other / unclassified | 0.0045 mg | Inhaled |