NCT01279668

Montelukast for Persistent Cough in Young People and Adults

A Double Blind Randomised Placebo Controlled Trial of Montelukast in the Treatment of Acute Persistent Cough in Young People and Adults in Primary Care

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 276 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 16 Years – 49 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Persistent Cough
• Whooping Cough

Interventions

Type	Name	Description
DRUG	Montelukast	10mg tablets, once per day for 28 days.
DRUG	Placebo	tablets, once per day for 28 days.

Timeline

• Start date: 2011-05-01
• Primary completion: 2012-10-01
• Completion: 2012-11-01
• First posted: 2011-01-19
• Last updated: 2012-10-10

Locations

1 site across 1 country: United Kingdom