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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01279668
First received: January 17, 2011
Last updated: October 8, 2012
Last verified: October 2012
History of Changes
  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 Intervention Phase
Persistent Cough
Whooping Cough
 Drug: Montelukast
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Oxford:

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 ]

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 ]

Enrollment: 276
Study Start Date: May 2011
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   16 Years to 49 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01279668

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

Additional Information:
Primary Care Clinical Trial Unit - MAC Trial  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01279668     History of Changes
Other Study ID Numbers: MAC_001, 2010-019647-19
Study First Received: January 17, 2011
Last Updated: October 8, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Oxford:
Montelukast
Persistent cough
Adults
Double-blind randomised placebo controlled trial

Additional relevant MeSH terms:
Cough
Whooping Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
 Infection
Montelukast
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013