Montelukast for Persistent Cough in Young People and Adults
Montelukast for Persistent Cough in Young People and Adults
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.
Inclusion Criteria:

 -  Male or Female, aged 16 years to 49 years inclusive.

 -  Presenting with a persistent cough of 2-8 weeks' duration without an established
 diagnosis (e.g. asthma, gastro-oesophageal reflux).

 -  Able to complete cough diary and study questionnaires.

 Exclusion Criteria:

 -  There is a contraindication to montelukast.

 -  Chronic severe disease which may cause persistent cough (eg cystic fibrosis,
 bronchiectasis, cardiac failure).

 -  Immunodeficiency/immunocompromised state.

 -  Pregnancy.

 -  Breastfeeding.

 -  Current smoker (i.e. stopped smoking less than 6 months ago).

 -  Regular medication associated with persistent cough (ACE inhibitors).

 -  The individual is in another clinical research study.