Montelukast for Persistent Cough in Young People and Adults

Study Overview
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Brief Summary
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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.

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

Conditions
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Persistent Cough, Whooping Cough

Intervention / Treatment
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* Drug: Montelukast
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Montelukast<br> | Drug: Montelukast<br>* 10mg tablets, once per day for 28 days.<br>* Other names: Singulair;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* tablets, once per day for 28 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Leicester Cough Questionnaire (LCQ) total score at 2 and 4 weeks post randomisation. |  | 2 and 4 weeks post randomisation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Leicester Cough Questionnaire (LCQ) physical, psychological and social domain scores at 2 and 4 weeks post randomisation. |  | 2 and 4 weeks post randomisation | 
| Overall cough severity according to cough visual analogue scale (VAS) scores over the 2-week period post randomisation (area under the curve). |  | 2 weeks post randomisation | 
| Paroxysmal cough severity over the 2-week period post randomisation (area under the curve). |  | 2 weeks post randomisation | 
| Proportions of participants reporting cessation of cough at 2 and 4 weeks post randomisation. |  | 2 and 4 weeks post randomisation | 
| Recruitment rate among young people and adults presenting with acute persistent cough. |  | End of study | 
| Follow-up rates at 2 weeks and 4 weeks post randomisation. |  | 2 weeks and 4 weeks post randomisation. | 
| Medication adherence rates at 2 and 4 weeks post randomisation. |  | 2 and 4 weeks post randomisation | 
| Prevalence of whooping cough among participants. |  | End of study | 
| Correlations between subjective cough outcome measures (diary-recorded paroxysms of cough, cough visual analogue scale score and exercise-related cough score) and objective cough frequency measured using the Leicester Cough Monitor. |  | 2 and 4 weeks post randomisation | 
| Proportions of participants undergoing further intervention (re-consultation, investigation, prescription of other medication). | Patient notes will be reviewed in this time frame | 4 - 8 weeks | 
| Proportions of participants with adverse events. |  | End of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Montelukast, Persistent cough, Adults, Double-blind randomised placebo controlled trial