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

Abstract

Background Asthma is a common chronic airway inflammatory disease. Exacerbation of asthma not only accelerates the progression of the disease, but also increases the incidence of hospitalization and death. Studies have shown that air pollution is a high-risk factor of exacerbation of asthma. However, there are rare treatment strategies recommended to reduce severe air pollution related exacerbation of asthma. Methods/design This is a single-center, prospective, randomized and standard treatment parallel control clinical trial. Seventy-two asthma patients in non-exacerbation stage according to GINA guidelines 2017 will be recruited and equally assigned to Rescue Intervention Strategy (RIS) group or the control group. Original treatments for participants include unused inhaled drug, use short-acting β-agonists (SABA) on demand or use Budesonide/Formoterol (160μg/4.5μg/ dose, 1-2 dose / time, b.i.d). The rescue intervention strategy for RIS group is Budesonide / Formoterol plus the original treatment until the end of severe pollution (air quality index, AQI<200). Control group will maintain the original treatment. The intervention will last for one year. Primary outcome is the frequency of exacerbation asthma per year. And the secondary outcomes include the number of unplanned outpatient visits, emergency visits, hospitalization, medical cost and mortality caused by exacerbation asthma per year. Discussion The rescue intervention strategy is a novel strategy for asthma management under severe air pollution. Results of the study will provide reference information to guide clinical practice in reducing the air pollution related exacerbation of asthma.