Montelukast for Persistent Cough in Young People and Adults (MAC)

• ClinicalTrials.gov Identifier: NCT01279668
• Recruitment Status: Unknown
• First Posted: January 19, 2011
• Last Update Posted: October 10, 2012
• Sponsor: University of Oxford
• Information provided by (Responsible Party): University of Oxford

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Persistent Cough; Whooping Cough	Drug: Montelukast; Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 276 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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

Arms and Interventions

Arm	Intervention/treatment
Experimental: Montelukast	Drug: Montelukast; 10mg tablets, once per day for 28 days.; Other Name: Singulair
Placebo Comparator: Placebo	Drug: Placebo; tablets, once per day for 28 days.

Outcome Measures

Primary Outcome Measures :

1. Change in Leicester Cough Questionnaire (LCQ) total score at 2 and 4 weeks post randomisation. [ Time Frame: 2 and 4 weeks post randomisation ]

Secondary Outcome Measures :

1. 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 ]
2. 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 ]
3. Paroxysmal cough severity over the 2-week period post randomisation (area under the curve). [ Time Frame: 2 weeks post randomisation ]
4. Proportions of participants reporting cessation of cough at 2 and 4 weeks post randomisation. [ Time Frame: 2 and 4 weeks post randomisation ]
5. Recruitment rate among young people and adults presenting with acute persistent cough. [ Time Frame: End of study ]
6. Follow-up rates at 2 weeks and 4 weeks post randomisation. [ Time Frame: 2 weeks and 4 weeks post randomisation. ]
7. Medication adherence rates at 2 and 4 weeks post randomisation. [ Time Frame: 2 and 4 weeks post randomisation ]
8. Prevalence of whooping cough among participants. [ Time Frame: End of study ]
9. 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 ]
10. 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
11. Proportions of participants with adverse events. [ Time Frame: End of study ]

Eligibility Criteria

• Ages Eligible for Study: 16 Years to 49 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United Kingdom

University of Oxford

Oxford, Oxfordshire, United Kingdom, OX3 7LF

Sponsors and Collaborators

University of Oxford

Investigators

• Principal Investigator: Anthony R Harnden; University of Oxford

More Information

Publications:

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University of Oxford
• ClinicalTrials.gov Identifier: NCT01279668
• Other Study ID Numbers: MAC_001; 2010-019647-19 ( EudraCT Number )
• First Posted: January 19, 2011
• Last Update Posted: October 10, 2012
• Last Verified: October 2012

Keywords provided by University of Oxford:

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

Additional relevant MeSH terms:

Whooping Cough; Cough; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Montelukast; Anti-Asthmatic Agents; Respiratory System Agents; Leukotriene Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 Enzyme Inducers; Molecular Mechanisms of Pharmacological Action