Salvational Intervention for Reducing AECOPD Under Severe Air Pollution
Condition: COPD Exacerbation; Air Pollution
Study type: Interventional

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.
    

Detailed description: 
      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.
    

Intervention name(s): Budesonide/formoterol; tiotropium bromide
Intervention type(s): Drug; Drug
Intervention description(s): 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.
Intervention MeSH terms: Budesonide; Bromides; Formoterol Fumarate; Tiotropium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: AECOPD; air pollution; COPD; salvational Intervention