Montelukast for Persistent Cough in Young People and Adults | RxWiki

Montelukast for Persistent Cough in Young People and Adults

Overview[ - collapse ][ - ]

Purpose	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	Persistent Cough Whooping Cough
Intervention	Drug: Montelukast Drug: Placebo
Phase	Phase 4
Sponsor	University of Oxford
Responsible Party	University of Oxford
ClinicalTrials.gov Identifier	NCT01279668
First Received	January 17, 2011
Last Updated	October 8, 2012
Last verified	October 2012

Tracking Information[ + expand ][ + ]

First Received Date	January 17, 2011
Last Updated Date	October 8, 2012
Start Date	May 2011
Estimated Primary Completion Date	November 2012
Current Primary Outcome Measures	Change in Leicester Cough Questionnaire (LCQ) total score at 2 and 4 weeks post randomisation. [Time Frame: 2 and 4 weeks post randomisation] [Designated as safety issue: No]
Current Secondary Outcome Measures	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] [Designated as safety issue: No] 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] [Designated as safety issue: No] Paroxysmal cough severity over the 2-week period post randomisation (area under the curve). [Time Frame: 2 weeks post randomisation] [Designated as safety issue: No] Proportions of participants reporting cessation of cough at 2 and 4 weeks post randomisation. [Time Frame: 2 and 4 weeks post randomisation] [Designated as safety issue: No] Recruitment rate among young people and adults presenting with acute persistent cough. [Time Frame: End of study] [Designated as safety issue: No] Follow-up rates at 2 weeks and 4 weeks post randomisation. [Time Frame: 2 weeks and 4 weeks post randomisation.] [Designated as safety issue: No] Medication adherence rates at 2 and 4 weeks post randomisation. [Time Frame: 2 and 4 weeks post randomisation] [Designated as safety issue: No] Prevalence of whooping cough among participants. [Time Frame: End of study] [Designated as safety issue: No] 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] [Designated as safety issue: No] Proportions of participants undergoing further intervention (re-consultation, investigation, prescription of other medication). [Time Frame: 4 - 8 weeks] [Designated as safety issue: No]Patient notes will be reviewed in this time frame Proportions of participants with adverse events. [Time Frame: End of study] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief Title	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
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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Condition	Persistent Cough Whooping Cough
Intervention	Drug: Montelukast 10mg tablets, once per day for 28 days. Other Names: SingulairDrug: Placebo tablets, once per day for 28 days. Other Names: Placebo
Study Arm (s)	Experimental: Montelukast Placebo Comparator: Placebo

Recruitment Information[ + expand ][ + ]

Recruitment Status	Active, not recruiting
Estimated Enrollment	276
Estimated Completion Date	November 2012
Estimated Primary Completion Date	October 2012
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.
Gender	Both
Ages	16 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United Kingdom

Administrative Information[ + expand ][ + ]

NCT Number	NCT01279668
Other Study ID Numbers	MAC_001
Has Data Monitoring Committee	Yes
Information Provided By	University of Oxford
Study Sponsor	University of Oxford
Collaborators	Not Provided
Investigators	Principal Investigator: Anthony R Harnden University of Oxford
Verification Date	October 2012

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