Montelukast for Persistent Cough in Young People and Adults

NCT ID: NCT01279668

Last Updated: 2012-10-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 276 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2012-11-30

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.

Conditions

Persistent Cough; Whooping Cough

Keywords

Montelukast; Persistent cough; Adults; Double-blind randomised placebo controlled trial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Montelukast

Group Type: EXPERIMENTAL

Montelukast

Intervention Type: DRUG

10mg tablets, once per day for 28 days.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

tablets, once per day for 28 days.

Interventions

Montelukast

10mg tablets, once per day for 28 days.

Intervention Type: DRUG

Placebo

tablets, once per day for 28 days.

Intervention Type: DRUG

Other Intervention Names

Singulair

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anthony R Harnden

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Locations

University of Oxford

Oxford, Oxfordshire, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 16829538 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12668799 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24461900 (View on PubMed)

Other Identifiers

2010-019647-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MAC_001

Identifier Type: -

Identifier Source: org_study_id