OBJECTIVE: Evaluate the efficacy of oral Montelukast 10 mg as an add-on therapy to the usual emergency therapy of an asthma crisis in an emergency room (ER). POPULATION: Twenty adults that sought medical attention in the ER of our Hospital and in whom, on admission, it appeared unnecessary to give systemic steroids. METHODS: All patients received the usual therapy of the asthma crisis. Simultaneously it was randomly administered a capsule containing 10 mg Montelukast or placebo, in a double-blind protocol. In both groups we evaluated the evolution of Peak-Flow values, the duration of stay in the ER as well as the need for additional therapy with systemic aminophylline or steroids, representing an insufficient response to the initial treatment. Student's T test was used to evaluate the statistical differences between these two groups. RESULTS: Both the Montelukast (MK) and Placebo (PL) groups were comparable regarding age and sex distribution, Peak-Flow values and Arterial O2 values on admission. During therapy, MK group had a shorter duration of ER stay (MK = 2.5 h; PL = 2.9 h) and a better evolution of Peak-Flow values (medium increase of 55% from baseline versus 44% in PL group). However these differences did not reach statistical significance. In the MK group one patient needed systemic steroids and 4 received systemic aminophylline while in the PL group 4 patients received systemic steroids and 8 aminophylline. This difference was significant (p = 0.03). We did not observe any significant side effects during therapy. CONCLUSIONS: Despite a small trend favourable to Montelukast we did not observe significant differences between groups regarding duration of stay or Peak-Flow evolution during therapy in ER, most probably due to the small sample size. However patients in the MK group needed significantly less systemic therapy with aminophylline or steroids. These data, in view of the very good safety profile of Montelukast, allow us to conclude that this is a useful additional therapy, which should be considered in the ER treatment of the asthma crisis.
RCT Entities:
OBJECTIVE: Evaluate the efficacy of oral Montelukast 10 mg as an add-on therapy to the usual emergency therapy of an asthma crisis in an emergency room (ER). POPULATION: Twenty adults that sought medical attention in the ER of our Hospital and in whom, on admission, it appeared unnecessary to give systemic steroids. METHODS: All patients received the usual therapy of the asthma crisis. Simultaneously it was randomly administered a capsule containing 10 mg Montelukast or placebo, in a double-blind protocol. In both groups we evaluated the evolution of Peak-Flow values, the duration of stay in the ER as well as the need for additional therapy with systemic aminophylline or steroids, representing an insufficient response to the initial treatment. Student's T test was used to evaluate the statistical differences between these two groups. RESULTS: Both the Montelukast (MK) and Placebo (PL) groups were comparable regarding age and sex distribution, Peak-Flow values and Arterial O2 values on admission. During therapy, MK group had a shorter duration of ER stay (MK = 2.5 h; PL = 2.9 h) and a better evolution of Peak-Flow values (medium increase of 55% from baseline versus 44% in PL group). However these differences did not reach statistical significance. In the MK group one patient needed systemic steroids and 4 received systemic aminophylline while in the PL group 4 patients received systemic steroids and 8 aminophylline. This difference was significant (p = 0.03). We did not observe any significant side effects during therapy. CONCLUSIONS: Despite a small trend favourable to Montelukast we did not observe significant differences between groups regarding duration of stay or Peak-Flow evolution during therapy in ER, most probably due to the small sample size. However patients in the MK group needed significantly less systemic therapy with aminophylline or steroids. These data, in view of the very good safety profile of Montelukast, allow us to conclude that this is a useful additional therapy, which should be considered in the ER treatment of the asthma crisis.