Montelukast for Persistent Cough in Young People and Adults (MAC)
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|ClinicalTrials.gov Identifier: NCT01279668|
Recruitment Status : Unknown
Verified October 2012 by University of Oxford.
Recruitment status was: Active, not recruiting
First Posted : January 19, 2011
Last Update Posted : October 10, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Persistent Cough Whooping Cough||Drug: Montelukast Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||276 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||May 2011|
|Estimated Primary Completion Date :||October 2012|
|Estimated Study Completion Date :||November 2012|
10mg tablets, once per day for 28 days.
Other Name: Singulair
|Placebo Comparator: Placebo||
tablets, once per day for 28 days.
- Change in Leicester Cough Questionnaire (LCQ) total score at 2 and 4 weeks post randomisation. [ Time Frame: 2 and 4 weeks post randomisation ]
- 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 ]Patient notes will be reviewed in this time frame
- Proportions of participants with adverse events. [ Time Frame: End of study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01279668
|University of Oxford|
|Oxford, Oxfordshire, United Kingdom, OX3 7LF|
|Principal Investigator:||Anthony R Harnden||University of Oxford|