Clinical trial of budesonide formoterol powder inhalation
1. This product maintains the clinical efficacy of treating asthma. Adult clinical trials show that adding formoterol to budesonide can improve asthma symptoms and lung function, and reduce the aggravation of the disease. In a study of 12 weeks, the effect of this product on lung function was similar to that of budesonide and formoterol respectively, but better than that of budesonide alone. All treatment groups used short-acting β2 adrenergic receptor agonists as needed. The anti-asthma effect does not weaken with the extension of use time. Clinical efficacy of maintenance and remission treatment with this product 12076 patients with asthma participated in five double-blind trials to observe the clinical efficacy and safety for 6 months or 12 months (among them, 4447 patients were randomly assigned to maintenance and remission treatment group with this product), and the selected patients were patients who still had asthma symptoms after taking glucocorticoid. Compared with the control group, the maintenance and remission treatment of this product has statistical and clinical significance in reducing severe asthma attacks in all five trials. These tests include a test to compare the higher maintenance dose of this product with terbutaline as a relief drug (test 735) and a test to compare the same maintenance dose of this product with formoterol or terbutaline as a relief drug (test 734) (table 1). In the 735 trial, the lung function, symptom relief and the use of palliative drugs were similar in each treatment group. In the 734 trial, compared with the two control groups, symptoms and palliative drugs were used less and lung function was improved. According to the results of five trials, 57% of patients who received maintenance and remission treatment of this product did not use remission drugs on the day of treatment. As time goes on, there is no tolerance. Table 1 Clinical Trial A Summary of Severe Deterioration in Hospitalization/Emergency Treatment or Oral Steroid Treatment. B compared with the two control groups, the deterioration rate decreased statistically (p value [o. 0 1]. In the other two experiments, this product can relieve bronchial contraction quickly and effectively for patients with severe asthma symptoms, and the effect is similar to that of salbutamol and formoterol. 2.COPD In two studies lasting 12 months, the pulmonary function and deterioration rate (defined as the process of oral steroid hormones and/or antibiotics and/or hospitalization) of patients with severe COPD were evaluated. At the time of registration, the median FEVl was 36% of the expected normal value. After taking this product (as defined above), the average number of patients who get worse every year is significantly lower than that of patients who take formoterol or placebo alone (the average speed is 1.4, while the placebo/formoterol group is 1.8- 1.9). During the period of 12 months, the average number of days of oral corticosteroids per patient in this product group decreased slightly (7-8 days/patient/year, while the placebo group and formoterol group were 1 1- 12 days and 9- 12 days respectively). For the changes of pulmonary function parameters, such as FEVl, the effect of this product is not better than that of formoterol Luo Qiang alone.