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The aims of this study were to determine the efficacy and tolerability of different dosages of, and to identify the best dosage of, tratinterol hydrochloride tablets in the treatment of bronchial asthma.This multicenter, randomized, double-blind, dose-finding clinical research study was completed at 3 centers in the People's Republic of China from March 2008 to February 2009. Each center selected patients with bronchial asthma whose forced expiratory volume in 1 second (FEV1) values were80% of predicted normal (pretreatment). Patients were assigned to 1 of 3 groups, based on daily dosage: low, 50 μg/d; intermediate, 100 μg/d; and high, 150 μg/d. Doses were administered orally twice daily for 10 days. The primary end points were the changes from baseline (0 minutes) in peak expiratory flow (PEF) and FEV1 at 30 minutes and 1, 2, 4, 6, and 12 hours after administration. Secondary end points were changes from baseline in forced vital capacity and asthma scores. Tolerability was monitored throughout the study period using physical examinations, laboratory testing, and spontaneous reporting.A total of 72 patients were selected in this study (24 per group; 40 men; 32 women; mean age, 43.48 years). The efficacy analysis (per-protocol set) included 20, 20, and 22 patients in the low-, intermediate-, and high-dosage groups, respectively. In terms of the primary and secondary end points, the intermediate dosage was most efficacious, followed by the high and low dosages, respectively. All 3 dosages were well-tolerated.In these patients with bronchial asthma, 100 μg/d was the dosage of tratinterol hydrochloride tablets most efficacious in terms of improvement in lung function. All 3 dosages were well-tolerated.

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.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.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 (P0.05). The fractional concentration of exhaled nitric oxide values of both groups were significantly decreased from before (P0.05). The secondary outcome measurements after treatment achieved obvious improvement from baseline (P0.05) 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.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.

The aim of this study was to determine the efficacy and safety profile of tratinterol hydrochloride tablets in the treatment of bronchial asthma.This multicenter, randomized, double-blind clinical research study was completed at 6 centers in the People's Republic of China from March 2009 to June 2010, and a randomized trial of procaterol hydrochloride tablets produced by Otsuka Pharmaceutical Co Ltd was conducted. The study was approved by the Medical Ethics Committee of the First Hospital of China Medical University. The clinical trial registration number is 2007L04263.A total of 223 patients were selected for this study, with 112 patients in the treatment group and 111 in the control group. The lung function of the 2 groups after treatment significantly increased in all (P0.05); however, there was no significant difference in the changes between the 2 groups (P0.05). The occurrence of related adverse events at varying degrees in the control group was higher than in the treatment group.It is safe and effective to use tratinterol hydrochloride tablets to treat bronchial asthma.

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 P P 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.