Comparison of the lung function change in patients with COPD and bronchial asthma before and after treatment with budesonide/formoterol

Objective

This study investigated the rapid onset of bronchodilation effect and compared lung function changes following budesonide/formoterol (Symbicort Turbuhaler®) inhalation in Chinese patients with moderate-severe chronic obstructive pulmonary disease (COPD) and bronchial asthma.

Methods

In this open-label, parallel-group clinical study, patients eligible for study were divided into COPD group (n=62, mean age 68.16±8.75 years) and asthma group (n=30, mean age 45.80±12.35 years). Lung function tests (include FEV1, FVC, FEV1/FVC, and IC) were performed at baseline (t=0 min time point, value before inhalation of budesonide/formoterol), and then eligible patients received two inhalations of budesonide/formoterol (160/4.5 μg). Lung function tests were reassessed at t=3, 10 and 30 min time point. The primary end-point was lung function change 3 min after drug inhalation, and the secondary end-points were comparison of the gas flow rate (ΔFEV1) and volume responses (ΔFVC, ΔIC) between COPD and asthma patients after inhalation of budesonide/formoterol.

Results

Compared with the baseline, all patients significantly improved their lung function (included FEV1, FVC, FEV1/FVC, and IC) at 3 min (P<0.05). Greater bronchodilation efficacy was found in the asthma group compared with the COPD group (P<0.05). In the asthmatic patients, the curves of FEV1, FVC, FEV1/FVC, IC, showed improvement with an ascending trend at all time points from 3 to 30 min. Whereas in the COPD patients, only the curves of FEV1, FVC, IC showed similar pattern. We found that ΔFVC was significantly higher than ΔFEV1 in both groups (P<0.05), but no significant difference between ΔIC and ΔFEV1 (P>0.05). Compared with COPD group, asthma group had higher level of ΔFEV1 and ΔIC (P<0.05), but no significant difference for ΔFVC can be found.

Conclusions

Budesonide/formoterol has a fast onset of bronchodilation effect in patients with moderate-severe COPD and asthma. Greater efficacy was found in the asthma group compared with the COPD group. The gas flow rate and volume responses in patients with COPD differ from those with asthma after inhalation of Budesonide/formoterol.KEY WORDS : Budesonide/formoterol, chronic obstructive pulmonary disease, bronchial asthma, lung function testChronic obstructive pulmonary disease (COPD) and bronchial asthma (asthma) have important similarities and differences. Both are chronic inflammatory diseases that cause airflow limitation (1,2). However, there are great difference between the two in terms of genetic basis, idiosyncratic reaction, airway hyper-responsiveness, inflammatory mediators and response to the treatment (3). There is neither study about the rapid onset of effect of ICS/LABA combination therapy (budesonide/formoterol) in China nor report about the differences of lung function change before and after treatment between patients with COPD and asthma all over the world.It is traditionally thought that the responses in bronchodilatation test of asthma and COPD are “gas flow rate responses” and “volume responses” respectively (1). But yet no report about the “gas flow rate responses” and “volume responses” of ICS/LABA such as budesonide/formoterol in patients with COPD and asthma is available.In this trial, we will determine the rapid onset of effect of budesonide/formoterol in patients with COPD and asthma by testing the lung function in several time points in a short time. In addition, we will discuss the differences of the gas flow rate and volume responses in patients with asthma and COPD after budesonide/formoterol inhalation.