Clinical trial NCT01279668: Montelukast for Persistent Cough in Young People and Adults
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Persistent Cough
Whooping Cough
Keywords: Montelukast
Persistent cough
Adults
Double-blind randomised placebo controlled trial
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2011-01-19
Enrollment: 276
Sex: ALL
Minimum age (years): 16
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Leicester Cough Questionnaire (LCQ) total score at 2 and 4 weeks post randomisation.
timeFrame: 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.
timeFrame: 2 and 4 weeks post randomisation
measure: Overall cough severity according to cough visual analogue scale (VAS) scores over the 2-week period post randomisation (area under the curve).
timeFrame: 2 weeks post randomisation
measure: Paroxysmal cough severity over the 2-week period post randomisation (area under the curve).
timeFrame: 2 weeks post randomisation
measure: Proportions of participants reporting cessation of cough at 2 and 4 weeks post randomisation.
timeFrame: 2 and 4 weeks post randomisation
measure: Recruitment rate among young people and adults presenting with acute persistent cough.
timeFrame: End of study
measure: Follow-up rates at 2 weeks and 4 weeks post randomisation.
timeFrame: 2 weeks and 4 weeks post randomisation.
measure: Medication adherence rates at 2 and 4 weeks post randomisation.
timeFrame: 2 and 4 weeks post randomisation
measure: Prevalence of whooping cough among participants.
timeFrame: End of study
measure: 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.
timeFrame: 2 and 4 weeks post randomisation
measure: Proportions of participants undergoing further intervention (re-consultation, investigation, prescription of other medication).
timeFrame: 4 - 8 weeks
measure: Proportions of participants with adverse events.
timeFrame: End of study
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: University of Oxford
state: Oxfordshire
Study officials:
affiliation: University of Oxford
name: Anthony R Harnden
role: PRINCIPAL_INVESTIGATOR
References:
citation: Harnden A, Grant C, Harrison T, Perera R, Brueggemann AB, Mayon-White R, Mant D. Whooping cough in school age children with persistent cough: prospective cohort study in primary care. BMJ. 2006 Jul 22;333(7560):174-7. doi: 10.1136/bmj.38870.655405.AE. Epub 2006 Jul 7.
citation: Birring SS, Prudon B, Carr AJ, Singh SJ, Morgan MD, Pavord ID. Development of a symptom specific health status measure for patients with chronic cough: Leicester Cough Questionnaire (LCQ). Thorax. 2003 Apr;58(4):339-43. doi: 10.1136/thorax.58.4.339.
citation: Wang K, Birring SS, Taylor K, Fry NK, Hay AD, Moore M, Jin J, Perera R, Farmer A, Little P, Harrison TG, Mant D, Harnden A. Montelukast for postinfectious cough in adults: a double-blind randomised placebo-controlled trial. Lancet Respir Med. 2014 Jan;2(1):35-43. doi: 10.1016/S2213-2600(13)70245-5. Epub 2013 Dec 2.