Overview

This trial is active, not recruiting.

Conditions persistent cough, whooping cough
Treatments montelukast, placebo
Phase phase 4
Sponsor University of Oxford
Start date May 2011
End date October 2012
Trial size 276 participants
Trial identifier NCT01279668, 2010-019647-19, MAC_001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
montelukast Singulair
10mg tablets, once per day for 28 days.
(Placebo Comparator)
placebo Placebo
tablets, once per day for 28 days.

Primary Outcomes

Measure
Change in Leicester Cough Questionnaire (LCQ) total score at 2 and 4 weeks post randomisation.
time frame: 2 and 4 weeks post randomisation

Secondary Outcomes

Measure
Change in Leicester Cough Questionnaire (LCQ) physical, psychological and social domain scores at 2 and 4 weeks post randomisation.
time frame: 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).
time frame: 2 weeks post randomisation
Paroxysmal cough severity over the 2-week period post randomisation (area under the curve).
time frame: 2 weeks post randomisation
Proportions of participants reporting cessation of cough at 2 and 4 weeks post randomisation.
time frame: 2 and 4 weeks post randomisation
Recruitment rate among young people and adults presenting with acute persistent cough.
time frame: End of study
Follow-up rates at 2 weeks and 4 weeks post randomisation.
time frame: 2 weeks and 4 weeks post randomisation.
Medication adherence rates at 2 and 4 weeks post randomisation.
time frame: 2 and 4 weeks post randomisation
Prevalence of whooping cough among participants.
time frame: 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.
time frame: 2 and 4 weeks post randomisation
Proportions of participants undergoing further intervention (re-consultation, investigation, prescription of other medication).
time frame: 4 - 8 weeks
Proportions of participants with adverse events.
time frame: End of study

Eligibility Criteria

Male or female participants from 16 years up to 49 years old.

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.

Additional Information

Official title A Double Blind Randomised Placebo Controlled Trial of Montelukast in the Treatment of Acute Persistent Cough in Young People and Adults in Primary Care
Principal investigator Anthony R Harnden
Trial information was received from ClinicalTrials.gov and was last updated in October 2012.
Information provided to ClinicalTrials.gov by University of Oxford.