A prospective study of salvational intervention with ICS/LABA for reducing chronic obstructive pulmonary disease exacerbation under severe air pollution (SIRCAP) in Beijing: protocol of a multi-center randomized controlled trial

Tianyu Zhou, Yijue Zhong, Jiping Liao, Guangfa Wang, Xueying Li, Xiaosen Qian, Pingchao Xiang, Xinsheng Chen, Zhenyang Xu, Fengzhen Zhang, Xiaoguang Wang, Senlin Wang, Xiangxin Li, Chunxiao Yu, Yongxiang Zhang, Guoguang Xia, Li Dai, Tianyu Zhou, Yijue Zhong, Jiping Liao, Guangfa Wang, Xueying Li, Xiaosen Qian, Pingchao Xiang, Xinsheng Chen, Zhenyang Xu, Fengzhen Zhang, Xiaoguang Wang, Senlin Wang, Xiangxin Li, Chunxiao Yu, Yongxiang Zhang, Guoguang Xia, Li Dai

Abstract

Background: Chronic Obstructive Pulmonary Disease (COPD) is a major cause of morbidity and mortality all over the world. Acute exacerbation of COPD (AECOPD) not only accelerates the progression of disease, but also causes hospital administration and death events. Epidemiologic studies have shown air pollution is a high risk factor of AECOPD. However, there are rare technics or treatment strategies recommended to reduce severe air pollution related AECOPD.

Methods: This is a multi-center, prospective, randomized and standard treatment parallel control clinical trial. Seven hundred sixty-four stable COPD patients in group B, C and D according to GOLD 2017 will be recruited and equally divided into two parallel groups, salvational intervention (SI group) and control group (CT group). Original treatments for participants include tiotropium (18μg once q.d), budesonide/formoterol (160μg/4.5μg once or twice b.i.d) or budesonide/formoterol (160μg/4.5μg once or twice b.i.d) with tiotropium (18μg once q.d). The savational intervention for SI group is routine treatment plus budesonide/formoterol (160μg/4.5μg once b.i.d) from the first day after severe air pollution (air quality index, AQI ≥200) to the third day after AQI < 200. CT group will maintain the original treatment. The intervention will last for 2 years. Primary outcome is the frequency of AECOPD per year and the secondary outcomes include the incidence of unplanned outpatient visits, emergency visits, hospitalization, medical cost and mortality associated with AECOPD per year.

Discussion: The salvational intervention is a novel strategy for COPD management under severe air pollution. Results of the present study will provide reference information to guide clinical practice in reducing the air pollution related exacerbation of COPD.

Trial registration: This study has been registered at www.ClinicalTrials.gov (registration identifier: NCT03083067 ) in 17 March, 2017.

Keywords: AECOPD; Air pollution; Budesonide/Formoterol; COPD; Salvational intervention.

Conflict of interest statement

Ethics approval and consent to participate

The first version study protocol has been approved by the Peking University First Hospital Institutional Review Board (IRB) (2016[1032]) on March 10th, 2016. Any protocol modifications will be submitted for the IRB review and approval.

The study will be conducted in accordance with Good Clinical Practice (GCP) requirements and ethical principles of the Declaration of Helsinki.

The purposes, procedures, as well as potential benefits and risks of the study will be explained carefully by investigators with a written informed consent. Written informed consent will be obtained from each participant or from the surrogate of the participant who cannot provide informed consent. Personal information and related documents of all participants will be kept strictly. Every participant will be identified by a subject number and a name acronym in the Case Report Form.

Consent for publication

Not applicable

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Figure 1
Figure 1
Flowchart of the study

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