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

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ClinicalTrials.gov Identifier: NCT01279668
Recruitment Status : Unknown
Verified October 2012 by University of Oxford.
Recruitment status was:  Active, not recruiting
First Posted : January 19, 2011
Last Update Posted : October 10, 2012
Information provided by (Responsible Party):
University of Oxford

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

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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

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.

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 ]

Information from the National Library of Medicine

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01279668

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United Kingdom
University of Oxford
Oxford, Oxfordshire, United Kingdom, OX3 7LF
Sponsors and Collaborators
University of Oxford
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Principal Investigator: Anthony R Harnden University of Oxford
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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    Key Record Dates
Last Update Posted: October 10, 2012
Last Verified: October 2012
Keywords provided by University of Oxford:
Persistent cough
Double-blind randomised placebo controlled trial
Additional relevant MeSH terms:
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Whooping Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Respiratory Tract Infections
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