The combination of montelukast and budesonide was found more effective than budesonide alone in children with chronic cough-variant asthma in a China retrospective study.
The combination of montelukast and budesonide was found more effective than budesonide alone in children with chronic cough variant asthma (CCVA), in a recent retrospective study conducted in China.
The condition is a very common subtype of bronchial asthma in children, according to Jin-fang Zhou, MB, Department of Pediatrics, Yan'an People's Hospital, Yan'an, China, and colleagues. As a possible precursor of asthma, early intervention with anti-inflammatory agents has been utilized.
The investigators noted previous studies which have demonstrated improvement with montelukast in both the symptoms and lung function in patients with CCVA, but that there are less data on the combination with budesonide.
"In has been reported that the combination of montelukast and budesonide may help to better manage the symptoms control, lung function improvement, and also against the airway narrow protection compared with inhaled corticosteroids alone," Zhou and colleagues wrote.
To add to these findings, the investigators identified 82 subjects aged 4-11 years old with CCVA, with 41 receiving the combination and 41 treated with budesonide alone for 8 weeks. The groups were generally matched in demographic and clinical variables.
Montelukast was administered as a 4 mg chewable tablet each evening and budesonide 1 mg tablet (dosage not available in US) three times daily. The investigators reported that after 8 weeks of treatment, patients receiving the combination demonstrated better outcomes in lung function, measured by peak expiratory flow rate (PEFR) and forced expiratory volume in 1 second (FEV1). The group receiving the combination also had better clinical assessment scores, including on measures of wheeze, activity, cough and sleep.
FEV1 increased from baseline to 8 weeks in the combination treatment group by approximately 17% while there was an approximate 9% increase in the group receiving budesonide alone. PEFR was improved by approximately 12% in the combination treatment group, while those on budesonide improved by 4%.
There were no serious adverse events in either study, and no patient withdrew due to adverse event. All adverse events in both groups were described as mild, and there were no significant difference between the groups in adverse events.
"The results showed that significant differences were found in the pulmonary function tests by FEV1 and PEFR, as well as the clinical assessment score after 8-week treatment," Zhou and colleagues concluded.
They acknowledge, however, that the study sample was small, taken from a single treatment center in China, and so the results may not apply across a larger population. In addition, the retrospective design is associated with other limitation, including an increased chance of selection bias.
"Larger sample size with longer treatment duration would still be required for further evaluation of the role (of the combination) in the treatment of CCVA," the investigators indicated.
The study, Montelukast and Budesonide Combination for Children with Chronic Cough-Variant Asthma, was published online in Medicine.