Montelukast for Persistent Cough in Young People and Adults

NCT01279668 | Unknown Phase 4 DMC

• 2 other identifiers: MAC_0012010-019647-19
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in Leicester Cough Questionnaire (LCQ) total score at 2 and 4 weeks post randomisation.

  2 and 4 weeks post randomisation

Secondary Outcomes (11)

• 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

• 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

• Paroxysmal cough severity over the 2-week period post randomisation (area under the curve).

  2 weeks post randomisation

• Proportions of participants reporting cessation of cough at 2 and 4 weeks post randomisation.

  2 and 4 weeks post randomisation

• Recruitment rate among young people and adults presenting with acute persistent cough.

  End of study

Study Arms (2)

Montelukast

EXPERIMENTAL

Drug: Montelukast

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Montelukast DRUG

10mg tablets, once per day for 28 days.

Also known as: Singulair

Montelukast

Placebo DRUG

tablets, once per day for 28 days.

Placebo

Eligibility Criteria

• Age: 16 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

University of Oxford

Oxford, Oxfordshire, OX3 7LF, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 16829538 BACKGROUND

• 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.

  PMID: 12668799 BACKGROUND

• 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.

  PMID: 24461900 DERIVED

MeSH Terms

Conditions

Chronic Cough; Whooping Cough

Interventions

montelukast

Condition Hierarchy (Ancestors)

Cough; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections

Study Officials

• Anthony R Harnden

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2011
• First Posted: January 19, 2011
• Study Start: May 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: November 1, 2012
• Last Updated: October 10, 2012

Record last verified: 2012-10

Locations

GB (1)