Montelukast for Persistent Cough in Young People and Adults

Whooping Cough Clinical Trial

— MAC  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01279668
• Other study ID #: MAC_001
• Secondary ID: 2010-019647-19
• Status: Active, not recruiting
• Phase: Phase 4
• First received: January 17, 2011
• Last updated: October 8, 2012
• Start date: May 2011
• Est. completion date: November 2012

Study information

• Verified date: October 2012
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 276
• Est. completion date: November 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 49 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cough
• Persistent Cough
• Whooping Cough

Intervention

Drug:
• Montelukast
10mg tablets, once per day for 28 days.
• Placebo
tablets, once per day for 28 days.

Locations

Country	Name	City	State
United Kingdom	University of Oxford	Oxford	Oxfordshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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. — View 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. Epub 2006 Jul 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Leicester Cough Questionnaire (LCQ) total score at 2 and 4 weeks post randomisation.		2 and 4 weeks post randomisation	No
Secondary	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	No
Secondary	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	No
Secondary	Paroxysmal cough severity over the 2-week period post randomisation (area under the curve).		2 weeks post randomisation	No
Secondary	Proportions of participants reporting cessation of cough at 2 and 4 weeks post randomisation.		2 and 4 weeks post randomisation	No
Secondary	Recruitment rate among young people and adults presenting with acute persistent cough.		End of study	No
Secondary	Follow-up rates at 2 weeks and 4 weeks post randomisation.		2 weeks and 4 weeks post randomisation.	No
Secondary	Medication adherence rates at 2 and 4 weeks post randomisation.		2 and 4 weeks post randomisation	No
Secondary	Prevalence of whooping cough among participants.		End of study	No
Secondary	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	No
Secondary	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	No
Secondary	Proportions of participants with adverse events.		End of study	Yes

External Links

•   Primary Care Clinical Trial Unit - MAC Trial