Montelukast for Persistent Cough in Young People and Adults
Status:
Unknown status
Trial end date:
2012-11-01
Target enrollment:
Participant gender:
Summary
Persistent cough is a common symptom, accounting for about 20% of referrals to outpatient
chest clinics. Most coughs are caused by self-limiting viral infections such as the common
cold. However, 1 in 4 people with a viral infection develop a persistent cough, which can go
on for several weeks. Whooping cough is a common cause of persistent cough in young people
and adults. Although the whooping cough vaccine gives lifelong protection against severe
infection, it does not appear to give such long-term protection against milder infections,
which can make someone cough for many weeks. There are currently no proven efficacious
treatments for persistent cough following either a viral infection or infection with whooping
cough.
Montelukast is a medication which is already licensed for the treatment of asthma. It works
by blocking the action of chemicals called leukotrienes, which make the airways of people
with asthma inflamed and sensitive. There is strong evidence to suggest that leukotrienes are
also involved in causing persistent cough following viral or whooping cough infection.
Montelukast may therefore also help settle persistent coughs in these settings.
Over 18 months, we will recruit patients aged 16-49 years with a cough lasting 2-8 weeks from
general practices in England. An oral fluid sample will be taken from each participant to be
tested for whooping cough. Participants will be randomly allocated to receive a 28-day course
of montelukast or placebo tablets and asked to complete a daily cough diary for two weeks.
They will be assessed after two weeks by their GP (face-to-face) and after four weeks by
another member of practice clinical staff (telephone). Some participants will be given a
24-hour cough monitor to wear on study entry and at two-week follow-up. This study will be
funded by the National Institute for Health Research's School of Primary Care.