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

Abstract

BackgroundChronic 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.MethodsThis 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.DiscussionThe 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 registrationThis study has been registered at www.ClinicalTrials.gov (registration identifier: NCT03083067) in 17 March, 2017.

The rescue intervention strategy for asthma patients under severe air pollution: a protocol for a single-centre prospective randomized controlled trial

“…The article by Zhou et al 2019 [ 6 ] is a protocol for a chronic obstructive pulmonary disease (COPD)-associated study that is being led by our department (Department of Respiratory and Critical Care Medicine, Peking University First Hospital). These two studies share some of the same research members, such as Guangfa Wang and Tianyu Zhou.…”

“…We followed the standardized programme intervention: Standard Protocol Item Recommendations for Interventional Trials (SPIRIT) 2013. We followed similar methods of Zhou et al 2019 [ 6 ], especially in the ‘ Intervention ’ and ‘ Outcomes ’ sections. Patients who meet the inclusion criteria (details are shown in the ‘ Inclusion criteria ’ section) and do not meet the exclusion criteria (details are shown in the ‘ Exclusion criteria ’ section) will be recruited from Peking University First Hospital.…”

The rescue intervention strategy for asthma patients under severe air pollution: a protocol for a single-center prospective randomized controlled trial

“…The article of Wang et al 2019 [6] is the protocol of the chronic obstructive pulmonary disease (COPD) associated study which is leading by our department (Department of Respiratory and Critical Care Medicine, Peking University First Hospital). And these two studies share some same researchmembers such as Guangfa Wang and Tianyu Zhou.…”

“…We followed the standardized program intervention: standard protocol items recommendations for interventional trials (SPIRIT) 2013. And we followed the similar methods of Wang et al 2019 [6], especially in 'Intervention' part and 'Outcomes' part. Patients identified at Peking University First Hospital who meet the inclusion criteria (the details are shown in 'Inclusion Criteria' part) and not the exclusion criteria (the details are shown in 'Exclusion Criteria' part) will be recruited.…”

Changes in air-pollution related behaviour measured by Google Trends Search Volume Index in response to reported air quality in Poland

“…For example, some researchers propose that there is no link between the chronic in ammatory skin diseases symptoms and air pollution, which has been shown with the use of Google Trends SVI analyses [40,41]. Also, increased air pollution levels may exacerbate the course of ongoing chronic diseases [42] and affected individuals may not know that. Therefore, starting with chronically ill patients and individuals who live in the most polluted regions worldwide, there is a need for health promotion programs focused on air pollution-related secondary and tertiary prevention strategies, including accurate symptom recognition.…”