An interventional study of Budesonide/formoterol and tiotropium bromide in COPD Exacerbation and Air Pollution, sponsored by Peking University First Hospital. Completed at 11 sites in China. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-03-31.
Sponsored by Peking University First Hospital · Not applicable, Interventional, and Prevention
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.
This is a multi-center, prospective, randomized and standard treatment parallel control clinical trial. A total of 764 stable COPD patients with history of exacerbation according to GOLD will be recruited and equally divided into two parallel groups, salvational intervention group (SI group) and control group (CT group). The randomization is stratified by medical center and the random code is designed in a 1:1 ratio. The Department of Respiratory and Critical Care of Peking University First Hospital is responsible for this research. Other 10 units participating in the study include Peking University Shougang Hospital, People's Hospital of Beijing Daxing District, Beijing Jingmei Group General Hospital, Beijing Miyun Hospital, Beijing Changping Hospital, The Hospital of Shunyi District Beijing, Beijing Luhe Hospital Capital Medical University, Civil Aciation General Hospital, Beijing Jishuitan Hospital and Aerospace 731 Hospital. These 11 centers approximately cover area from urban to suburbs in Beijing.
Inhaled tiotropium bromide(18ug), budesonide/formoterol（160ug/4.5ug）or tiotropium bromide(18ug)+ budesonide/formoterol （160ug/4.5ug）will be used as basic medicine. On the foundation of basic medicine, inhaled budesonide/formoterol（160ug/4.5ug）will be used as an intervention drug for patients in SI group. When air quality index (AQI) is above 200, they will temporary add one inhalation of budesonide/formoterol（160ug/4.5ug）twice a day until the third day after AQI drops below 200. CT group maintains the original treatment. Besides baseline, patients will be formally visited 4 or 5 times during this trial: before randomization (for those who need pharmacological washout) and every six months after randomization.
Primary outcome is the frequency of AECOPD per year, which is defined as the frequency of AECOPD/the number of patients/year. Secondary outcomes include the number of unplanned outpatient visits, emergency medical visits, hospitalization, medical expense and mortality caused by AECOPD per year.
The study protocol has been approved by the Peking University First Hospital Institutional Review Board (IRB) (2016[1032]). Any protocol modifications will be submitted for the IRB review and approval.
Peking University First Hospital is the lead sponsor of 378 studies on the registry; 178 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Budesonide/formoterol（160ug/4.5ug）will be used as an intervention drug on the foundation of original treatment.
Drug: Budesonide/formoterol · Drug: tiotropium bromide
CT group maintain the original treatment
Drug: tiotropium bromide
On the foundation of basic treatment strategies, inhaled budesonide/formoterol（160ug/4.5ug）will be used as an intervention drug for patients in PIC group. When air quality index (AQI) is above 200, they will temporary add one inhalation of budesonide/formoterol（160ug/4.5ug）twice a day until the third day after AQI drops below 200.
Inhaled tiotropium bromide(18ug) will be used as routine medicine according to doctor's advice.
the frequency of exacerbation of COPD per year
Time frame: 3 year
the number of unplanned outpatient visits caused by exacerbation of COPD per year
Time frame: 3 years
the number of unplanned emergency medical visits caused by exacerbation of COPD per year
Time frame: 3 years
the number of unplanned hospitalization caused by exacerbation of COPD per year
Time frame: 3 years
the cost of unplanned medical expense caused by exacerbation of COPD per year
Time frame: 3 years
the number of unplanned mortality caused by exacerbation of COPD per year
Time frame: 3 years
Plan to share: No
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Peking University First Hospital