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.

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.