drugset / Trial / NCT05152355
Clinical Equivalence of Budesonide HFA MDI Versus Budesonide Turbuhaler in Mild to Moderate Chinese Asthma Patients
Phase 4
Completed
270 enrolled
Intech Biopharm Ltd.
Bao Gang Hospital · collabBeijing Aicomer Pharmaceutical Technology Co., Ltd. · collabBeijing Friendship Hospital · collabBeijing Yi Hua Hospital Management Co., Ltd · collabDaqing Oil Field Hospital · collabFirst Affiliated Hospital of Jinan University · collabGCP ClinPlus Co., Ltd. · collabHealthcare Inc · collabJining Medical University · collabKey Tech · collabMeiheko Central Hospital · collabMeizhou People's Hospital · collabPeking University People's Hospital · collabQingdao Municipal Hospital · collabShaanxi Provincial People's Hospital · collabThe Affiliated Hospital of Inner Mongolia Medical University · collabThe First Affiliated Hospital of Shanxi Medical University · collabThe Second Hospital of Hebei Medical University · collabTianjin First Central Hospital · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
The primary objective of this study is to compare the efficacy and safety of budesonide HFA MDI 200 mcg 2 puffs BID versus budesonide DPI (Turbuhaler) 100 mcg 4 puffs BID in Chinese mild to moderate Asthma patients.
Timeline
- Start
- 2019-04-22
- Primary completion
- 2021-05-09
- Completion
- 2021-05-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Budesonide | Small molecule | 100 ug | Inhaled |
| Subject | Budesonide | Small molecule | 200 ug | Inhaled |