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

ABSTRACT

OBJECTIVE: The aim of our study is to provide a novel strategy to administer treatment at the first signs of severe air pollution and before patients experience symptoms for preventing airway damage. METHODS: This single-center, prospective, randomized and standard treatment parallel control clinical trial recruited adult asthma patients. The patients were randomized into either the rescue intervention strategy (RIS) group or control group. The rescue intervention strategy for the RIS group included budesonide/formoterol plus the original treatment until the severe pollution ended. The control group was maintained on the original treatment. The follow-up observation period was 1 year. RESULTS: Overall, 22 participants were enrolled and 20 completed the follow-up (11 in the RIS group and 9 in the control group). Two participants dropped out of the trial for personal reasons before the first follow-up. In the intention-to-treat analysis, the frequency of asthma exacerbations per year was significantly lower in the RIS group than in the control group (RIS vs. control, 0.55 vs. 2.67; risk rate [RR] [95% confidence interval {CI}], 0.21 [0.08-0.50]; p = 0.001). The mean number of unplanned outpatient visits per person per year was also lower in the RIS group than in the control group (RIS vs. control, 0.18 vs. 1.11; RR [95% CI], 0.16 [0.04-0.75]; p = 0.019). CONCLUSION: A novel strategy to administer treatment at the first signs of severe air pollution and before patients experience symptoms may decrease the risk of asthma exacerbations and negative outcomes under severe air pollution conditions. TRIAL REGISTRATION ChiCTR, ChiCTR1900026757. http//www.chictr.org.cn.