drugset / Trial / NCT02162784
Efficacy Study of SYN006 HFA MDI in Asthma Patients
RandomizedCrossoverOpen-labelTreatment
Summary
The objective of the study is to evaluate the dose response of SYN006 HFA MDI, which is a combination drug product of budesonide and procaterol hydrochloride, in asthma patients. Patients with mild to moderate asthma will be recruited. There will be two study medication administered in this study. The investigational medication is SYN006 (Budesonide/Procaterol hydrochloride, 180 mcg/10 mcg per inhalation) and the active comparative medication is Ventolin (Salbutamol sulfate 100 mcg per inhalation). The study medication will be administered by oral inhalation with the supervision of the investigator or a qualified staff.
Timeline
- Start
- 2013-02
- Primary completion
- 2014-08
- Completion
- 2014-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Budesonide | Small molecule | 180 ug | Inhaled |
| Subject | Budesonide | Small molecule | 360 ug | Inhaled |
| Subject | Procaterol | Other / unclassified | 10 ug | Inhaled |
| Subject | Procaterol | Other / unclassified | 20 ug | Inhaled |
| Comparator | Salbutamol | Unknown | 200 ug | Inhaled |