A new study’s lead author notes, however, that lack of significant effect may have been secondary to important study limitations.
Adding montelukast to the treatment of asthma in the elderly has no effect on asthma symptoms, according to a new study.
Little is known about asthma in the elderly since most studies exclude older patients. Leukotriene receptor antagonists benefit younger asthmatics, but their value is largely unknown in elderly asthmatics, stated author Michel Columbo. Two open label studies in those over age 60 years showed that the leukotriene receptor antagonist montelukast may provide clinical benefit when added to inhaled corticosteroids-including a reduction of asthma exacerbations, and reduction of the percentage of days with asthma.
Montelukast is FDA-approved for the treatment of asthma in those who are 12 months old and older. It has been shown to improve asthma symptoms and spirometric values, and to decrease asthma exacerbations.
Columbo conducted a double-blind, placebo-controlled study of the effect of montelukast on 25 patients with asthma who were age 65 years or older. Each patient received montelukast 10 mg and then placebo for 8 weeks in a cross-over design. They were evaluated at week 0, 1, 5, 9, 13, and 17.
She published her results in the April 17, 2017 Asthma Research and Practice.
The results of the pilot show that montelukast for 4 or 8 weeks did not significantly affect the Asthma Control Test (ACT), daily symptom scores, number of puffs of albuterol, spirometric values, peripheral blood eosinophils, or serum IgE vs baseline or placebo. Similar results were obtained for subgroups of patients with lower ACT, lower FEV1, and higher eosinophils.
...montelukast ...did not significantly affect the Asthma Control Test, daily symptom scores, number of puffs of albuterol, spirometric values, peripheral blood eosinophils, or serum IgE vs baseline or placebo.
Montelukast for 8 weeks appeared to reduce daily symptoms scores and number of puffs of albuterol relative to placebo, but the results did not reach statistical significance, possibly due to low baseline values, stated Columbo. “Indeed, a significant limitation of our results is that most study subjects had well controlled asthma. The lack of effect of montelukast on clinical parameters could have been the result of this limitation,” she stated.
Previous studies show mixed results with montelukast regarding eosinophils. One study found decreases in peripheral blood eosinophils, while another study failed to detect an effect of montelukast on sputum eosinophils when added to inhaled corticosteroids.
“In the present study of elderly asthmatics, montelukast did not affect peripheral blood eosinophils or serum IgE levels. Montelukast appeared to decrease eosinophils in subjects with higher baseline blood counts of these cells, but these results did not reach statistical significance possibly due to the small number of observations,” stated Columbo. She hypothesized that this subgroup of patients may be more responsive to the drug.
The study was relatively small, and patients were almost exclusively Caucasian. “It is possible that a longer duration of treatment might have yielded different results. It is also possible that montelukast may have a positive effect on other important clinical parameters, such as asthma exacerbations and asthma-related emergency room visits that could not be assessed in our study,” stated Columbo.
These results need to be confirmed in larger studies enrolling subjects with uncontrolled asthma, she stated.