Short-term responses to high-dose inhaled corticosteroid treatment in patients with chronic obstructive pulmonary disease having a fractional nitric oxide concentration over 35 parts per billion: a single-center pre-post study

Background: There is currently no strategy to identify chronic obstructive pulmonary disease (COPD) patients whose pulmonary function could benefit from inhaled corticosteroids. This study investigates whether a 28-day regime of inhaled corticosteroids improves pulmonary function test results among chronic obstructive pulmonary disease patients having a fractional exhaled nitric oxide concentration > 35 parts per billion.
Methods: This was a single-center one-arm pre–post trial. Chronic obstructive pulmonary disease patients with a fractional exhaled nitric oxide concentration > 35 parts per billion treated at our institution from September 2018 to August 2019 were included. Each patient was administered budesonide (200 μg, 8 puffs daily) for 28 days. The primary outcome measure was the difference between the values of forced expiratory volume in 1 s (FEV1) at baseline and 28 days after inhaled corticosteroid initiation. Secondary outcomes included differences of Chronic Obstructive Pulmonary Disease Assessment Test scores, %FEV1, and that between the percent forced vital capacity at baseline and 28 days after inhaled corticosteroid initiation.
Results: Twenty patients were included; all patients completed the 28-day inhaled corticosteroid regime. The mean difference in FEV1 between day 1 and 28 days after inhaled corticosteroid initiation was 340 mL (95% confidence interval: −100 to 770 mL; p = 0.122). The mean differences in secondary outcomes were: % forced vital capacity , −0.16% (95% confidence interval: −2.84 to 2.53%; p = 0.905); %FEV1, 1.63% (95% confidence interval: −4.56 to 7.81%; p = 0.589); Chronic Obstructive Pulmonary Disease Assessment Test score, −2.50 (95% confidence interval: −5.72 to 0.72; p = 0.121).
Conclusion: The 28-day course of inhaled corticosteroids showed no significant difference in FEV1 for chronic obstructive pulmonary disease patients having fractional exhaled nitric oxide concentration > 35 parts per billion.