Intervention Studies of Inhaled Corticosteroids Combined with Long-acting Theophylline or Long-acting β2- agonists in Patients with Moderate to Severe Asthma: A Randomized, Controlled Study

Abstract Purpose To evaluate and contrast the therapeutic effect and safety of fluticasone aerosol combined with theophylline tablets in patients with moderate to severe asthma, compared with salmeterol/fluticasone propionate aerosol. Methods After a screening period, patients meeting the inclusion criteria were randomly assigned to the experiment group (fluticasone aerosol combined with theophylline tablets) or the control group (salmeterol/fluticasone aerosol combined with placebo tablets) for 12 weeks of treatment. The main outcome measurements were forced expiratory volume in 1 second and fractional concentration of exhaled nitric oxide value, whereas the secondary measures were forced vital capacity, peak expiratory flow value, and Asthma Control Test/Asthma Quality of Life Questionnaire score. Findings Forty-four cases completed the course, with 23 cases in the experiment group and 21 cases in the control group. The forced expiratory volume in 1 second values of both groups were significantly improved from before ( P < 0.05). The fractional concentration of exhaled nitric oxide values of both groups were significantly decreased from before ( P < 0.05). The secondary outcome measurements after treatment achieved obvious improvement from baseline ( P < 0.05) in both. There was no significant difference between the 2 groups in all measurements. In addition, the blood biochemistry results, ECG results, and vital signs of both groups had no significant abnormality. Implications There was no significant difference in therapeutic effect and safety between the 2 groups in treating patients with moderate to severe persistent asthma, which suggests that fluticasone aerosol combined with theophylline tablets is worth considering for use in primary hospitals or for low-income populations.