A new approach to the management of patients with bronchial asthma. The most important study.

Despite the availability of effective anti-asthma drugs, many patients with bronchial asthma (BA) of disease control remains sub-optimal. Often, patients relying on short-acting bronchodilators, anti-inflammatory therapy is neglected, thus increasing the risk of asthma exacerbation.

In the February issue of the journal Chest published results of the first of its kind randomized, double-blind study of new therapeutic strategies based on the use of glucocorticoid (GC), budesonide (B) and β2-agonist formoterol (F) contained in a single inhaler (B + F). Since F begins to act as quickly as salbutamol, a new approach is consistent with the current guidelines, according to which persistent asthma patients should receive daily anti-inflammatory treatment with a rapid increase in the dose of drugs at the time of symptoms and enhance contrast, reduce the dose when restoring a good control of the disease.

Methods and progress of studies

The study was conducted in 77 centers in 9 countries (Argentina, Brazil, Denmark, Indonesia, Spain, China, Norway, Philippines, Sweden). Included patients aged 12 to 80 years with a diagnosis of persistent asthma mild to moderate set of at least 6 months. Forced expiratory volume in 1 second (FEV1) of patients had to be 60 to 100% of the normal value in 15 minutes after the inhalation of 1 mg terbutaline (T) increase in FEV1 ≥ 12%, and for adults, in addition, an increase in FEV1 ≥ after inhalation of 200 ml of β-agonist. In the absence of these criteria, the reversibility of airflow obstruction in the study participants could be included with the variability of peak expiratory flow (PEF) ≥ 12% for at least 3 days in the last 10 days. All patients received a dose of inhaled GC 200-500 mg / day for at least 3 months during the last month.

Exclusion criteria were: use of systemic GC or Cromones during the previous month; respiratory infections, control violating the disease during the month; severe comorbidities; smoking (with a history of> 10 years-Packaging). The use of anticholinergics and xanthine are not allowed, except for the period of hospitalization.

During open introductory study period (14-18 days), all subjects received inhaled B at 100 mg twice a day, if necessary, at 0.5 T g. The number of inhalations β-agonist had to be not less than 7 during the last 10 days, but less than 10 per day for every day of the run-in period. Thus, participants with severe asthma exacerbations were excluded from the study.

Patients were randomized into groups: the use of B + P (constant intake of 80 mg / 4.5 mg to 2 inhalations in the evening (inhaler number 1) + inhalation "on demand" (inhaler number 2)) for 6 months - treatment group; the use of double doses of B (160 mcg 2 inhalations for the evening (inhaler number 1)) + T inhalation (0.4 mcg (inhaler number 2)) "on demand" - a comparison group. It is allowed to receive a maximum of 10 inhalations "on demand" in the day, otherwise it was a question of the extension study. Thus, in group B + F participants can receive the maximum daily dose of B / F 960/54 ug.

To monitor the effectiveness of interventions to patients daily inhalation in the morning and evening peak flow meter was measured using PSV. Control Spirometry was performed at 1, 3 and 6 months of the study. The severity of daytime and nighttime asthma symptoms assessed separately on a 4-point scale (where 0 points - the absence of symptoms, 3 points - severe symptoms) and then summed.

Calculating the percentage of days without asthma symptoms, the percentage of days without inhalation "on demand", for a total of the number of days of asthma control. Exacerbations of the disease were considered as severe in the case of hospitalization, the need to assign system HA reduction ≥ 30% of PSV for 2 consecutive days. Patients with severe exacerbations of prednisone orally received 30 mg / day for 10 days. The need to further prednisone was seen as a re-aggravation. Patients who needed 3 or more courses of systemic GC, were excluded from the study.

Results

Total randomized 697 patients (mean age 38 years; 270 men). The group P + P included 355 people, a group of a double dose of B - 342 participants. Before randomization, 95% of participants had symptoms of asthma, including 43% - nocturnal symptoms. Initially groups were comparable for clinical and demographic characteristics and the number of used "on demand" dose: an average of 1.6 vs. 1.8 inhalations per day. Adherence to treatment was high in both groups (> 97% of participants). Eliminated from the study of 27 patients in the treatment group and 31 patients in the comparison group.

Patients from group B + P compared with group B noted a significant improvement in morning PEF (34.5 l / min versus 9.5 l / min; p <0.001) and evening PEF (25 l / min to 7 l / min ; p <0, 001), which appeared at the beginning of the study and remained to the end. The same trend is observed and dynamic assessment of FEV1: 0.210 l vs. 0.062 L, respectively (p <0.001).

Patients from group B + F reported better control of the disease: the scale of asthma severity (score 0.73 versus 0.94; p <0.001) in the number of asymptomatic days (55.1 vs. 46.4%; p = 0.004) , the number of days without inhalation "on demand" (55.3 vs. 45.4%; p <0.001) and in the percentage of asthma control days (47.4 vs. 38.8%, respectively; p = 0.0012).

The risk of severe asthma exacerbations was 54% lower in the intervention group (43 vs. 94, respectively aggravation; p = 0.0011). Also, there was a decrease by 76% the frequency of exacerbations that required hospitalization or application of the system of the Civil Code (14 cases vs. 57; p <0.001), and 90% - the risk of emergency hospital admissions (1 case vs. 10, respectively; p = 0.026). In general, the risk of developing at least one severe exacerbation was lower in group B + F by 70% (p <0.001), which when extrapolated to 1 year of therapy was 27 fewer exacerbations per 100 patients treated.

Greater efficiency in the intervention group B + F was achieved using a lower dose of inhaled GC (240 mg / day to 320 mg / day in group B). In addition, patients in the intervention group 77% less likely to have received oral HA (114 days versus 498 days in the control group), and also less likely to use inhaled "on demand" (1.04 / day compared to 1.48 / day; p <0.001 ).

Both modes of therapy were well tolerated. Adverse reactions were mostly mild or moderate in intensity, with the same frequency in groups. Clinically significant between-group differences in ECG, haematological and biochemical parameters were observed.

Conclusions

The new approach of management of patients with asthma, which consists in the use of low maintenance dose of P + F in a single inhaler, with additional doses of B + F "on demand", improves and simplifies the control of the disease compared with conventional therapy.

Application B + F reduces hospitalization and use of the system frequency at a lower dose of HA HA inhalation, thereby improving the ratio of the risk / benefit compared to a fixed dose B.

The authors suggest that these results call into question the need for the traditional use of short-β-agonists for relief of symptoms of the disease and may contribute to the revision of the existing recommendations on the management of patients with asthma.


Comments:


Leave Your Comment:

Enter Username*:
Enter Your Comment*:




Site Search
Information!
Site materials are informative and educational in nature. If you suffer from any pain or other health problems, always consult your doctor for further advice. Do not engage in self!
© 2016 prednisone-info.com
Copying of materials is prohibited.
© prednisone-info.com - all about pain relief online.