Inhaled corticosteroid (ICS) and long-acting beta2-agonist (LABA) combination vs. high doses of ICS: efficacy and safety in patients (pts) with uncontrolled occupational asthma

Abstract

Aim: To evaluate efficacy and safety of ICS/LABA combination vs. ICS high doses in pts with uncontrolled occupational asthma. Study population. 30 pts with l asthma uncontrolled on a low ICS doses. Methods: At baseline all pts were randomly separated on 2 groups: 15 pts (Group I) were withdrawn from their ICS and prescribed combination of Budesonide 160 mcg/Formoterol 4.5 mcg BID (Bufomix Easyhaler®, Orion Corporation, Finland); for 15 pts (Group II) their doses of ICS were increased up to high. Spirometry data, Asthma control questionnaire (ACQ), heart rate (HR), blood pressure (BP) were evaluated at baseline and 16weeks after beginning of therapy. Asthma exacerbations and respiratory infections episodes during 16 weeks were counted. Results: Both groups were similar regarding to age and sex. At the beginning of the study there were no differences in FEV1, ACQ, HR and BP between groups. After 16 weeks pts of both groups demonstrate increasing in FEV1, however in Group I this improvement was higher than in Group II (198.0[176.0-320.0] ml vs. 172.0[150.0-190.0] ml, p=0.035). Asthma control was reached in pts of both groups, but ACQ were significantly better in Group I (0.6[0.0-1.3]) than in Group II (1.2[1.0-1.3]), p=0.019. There was no any significant difference in number of asthma exacerbations and respiratory infections episodes during 16 weeks between groups. HR and BP did not change significantly from baseline in both groups. Conclusion: In pts with uncontrolled occupational asthma ICS and LABA combination is more effective then high doses of ICS; both treatment strategies are comparable by safety.