PURPOSE: Chronic cough, i.e. cough lasting more than 8 weeks, is a frequent and debilitating symptom. One of the most common causes of chronic cough is cough variant asthma. In asthma in general, leukotriene receptor antagonists like montelukast have a beneficial effect on symptoms, PEF and quality of life. Our objective is to determine whether montelukast on top of inhaled corticosteroid (ICS) has beneficial effects on cough and cough related quality of life compared to placebo in patients with cough variant asthma.
METHODS: A single-centre, double blind, placebo-controlled, randomized trial (NCT00453765) was performed. Patients were recruited from our cough clinic which has a strictly standardized algorithm for diagnosis and therapy. Eligibility criteria included age between 18 and 90 years, chronic cough and bronchial hyperreactivity (metacholine PD20<2.5mg). Patients received montelukast once daily 10 mg for 6 weeks or identical placebo. All participants also received inhaled corticosteroids in stable dose. The primary outcome was mean change in LCQ total-score after 6 weeks. Secondary outcomes included a change in cough-VAS-scores after 6 weeks and safety outcomes.
RESULTS: 89 Patients were randomized, however 10 patients withdrew consent within 1 week. Therefore data of 79 patients were analyzed. Baseline characteristics of both groups were similar: mean age was 58±13 years, 21 were atopic. 74 received ciclesonide 160mcg once daily, 2 received combination glucocorticoid/B2sympathicomimetics at start of study. The mean change in LCQ total-scores and VAS-scores after 6 weeks for the montelukast and placebo-group were respectively 3.02±3.43 versus 3.08±2.84 (mean difference -0.16, 95%CI: -1.46; 1.14, p=0.81) and -21±31mm versus -19±26mm (difference 3, 95%CI: -9;15, p=0.63). There were no serious adverse events, and only a few participants reported minor side effects, mostly gastro-intestinal.
CONCLUSIONS: Patients with cough variant asthma treated according to a standardized cough algorithm experienced a clinically significant improvement in health status, however montelukast had no additional beneficial effect on top of ICS.
CLINICAL IMPLICATIONS: Montelukast has no additional benefit in patients with well treated cough variant asthma.
DISCLOSURE: The following authors have nothing to disclose: Lisenka Boom, Dominique Vaessen, Steven Uil, Huib Kerstjens, Jan Willem van den Berg
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