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Background Post-infectious cough is common in primary care, but has no proven effective treatments. Cysteinyl leukotrienes are involved in the pathogenesis of post-infectious cough and whooping cough (pertussis). We determined the effectiveness of montelukast, a cysteinyl leukotriene receptor antagonist, in the treatment of post-infectious cough. Methods Non-smoking adults aged 16 to 49 years with post-infectious cough of two to eight weeks’ duration were recruited from 25 general practices in England. Patients were tested for pertussis (oral fluid anti-pertussis toxin IgG) and randomly assigned to montelukast 10 mg daily or image-matched placebo for two weeks. Patients chose whether to continue study medication for another two weeks. The randomisation sequence was computer-generated and stratified by general practice. Patients, healthcare professionals and researchers were blinded to treatment allocation. Effectiveness was assessed using the Leicester Cough Questionnaire to measure changes in cough-specific quality of life between baseline and two follow-up stages (two weeks and four weeks). The primary analysis was by intention to treat with imputation by last observation carried forward. Recruitment closed on 21st September 2012 and follow-up has been completed. Findings We randomly assigned 276 patients to montelukast (n=137) or placebo (n=139). Seventy patients had laboratory-confirmed pertussis (25%). Improvements in cough-specific quality of life occurred in both groups after two weeks (montelukast: mean 2•7, [95% confidence interval 2•2 to 3•3]; placebo: 3•6 [2•9 to 4•3], p=0•04) but the difference between groups was not clinically significant (mean difference -0•9 [-1•7 to -0•04]). This difference was not statistically significant in any sensitivity analyses. After two weeks, 74•1% of patients elected to continue study medication (montelukast 76•7%; placebo 71•5%). After four weeks, there were no significant between-group differences in cough-specific quality of life improvement (montelukast: 5•2 [4•5 to 5•9]; placebo: 5•9 [5•1 to 6•7]; mean difference -0•5 [-1•5 to 0•6], p=0•38) or adverse event rates (montelukast 15•3%; placebo 22•3%, p=0•14). The most common adverse events reported were increased mucus production (montelukast, n=6; placebo, n=2) and headache (montelukast, n=2; placebo, n=6). One serious adverse event was reported (placebo, n=1), which was unrelated to study medication (shortness of breath and throat tightness after severe coughing bouts). This trial is registered with EudraCT (2010-019647-19), UKCRN Portfolio (ID 8360), and (NCT01279668). Interpretation Montelukast is not an effective treatment for post-infectious cough. However, the burden of post-infectious cough in primary care is high, making it an ideal setting for future anti-tussive treatment trials.

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Journal article


The Lancet Respiratory Medicine


The Lancet Respiratory Medicine

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Dr Kay Wang , E-mail: , Telephone: +44 (0)1865 289312,