drugset / Trial / NCT03083067
Salvational Intervention for Reducing AECOPD Under Severe Air Pollution
Completed
402 enrolled
Peking University First Hospital
Aerospace 731 Hospital · collabBeijing Changping Hospital · collabBeijing Jingmei Group General Hospital · collabBeijing Jishuitan Hospital · collabBeijing Luhe Hospital · collabBeijing Miyun Hospital · collabBeijing Shuyi Hospital · collabCivil Aviation General Hospital · collabPeking University Shougang Hospital · collabPeople's Hospital of Beijing Daxing District · collab
RandomizedParallel-groupOpen-labelPrevention
Summary
This is a multi-center, prospective, randomized and standard treatment parallel control clinical trial.A total of 764 stable COPD patients according to GOLD will be recruited and equally divided into two parallel groups, salvational intervention group (SI group) and control group (CT group).On the foundation of basic medicine, inhaled ICS/LABA will be used as an intervention drug for patients in SI group on severe air pollution days. It is aimed to evaluate whether this novel treatment strategy will decrease the frequency of AECOPD per year.
Timeline
- Start
- 2017-03-20
- Primary completion
- 2022-03-16
- Completion
- 2022-03-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | budesonide/formoterol | Unknown | 4.5 ug | Inhaled |
| Subject | budesonide/formoterol | Unknown | 160 ug | Inhaled |
| Background | Tiotropium | Other / unclassified | 18 ug | Inhaled |