Acute persistent cough with no established diagnosis
Conditions
Interventions
Trade Name: Singulair®
Product Name: Montelukast
Pharmaceutical Form: Tablet
INN or Proposed INN: montelukast
CAS Number: 158966-92-8
Concentration unit: mg milligram(s)
Concentration type: equal
Conc
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Male or Female, aged 16 years to 49 years inclusive. 2)Presenting with a persistent cough of 2-8 weeks' duration without an established diagnosis (e.g. asthma, gastro-oesophageal reflux). 3)Able to complete cough diary and study questionnaires. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: The participant may not enter the study if ANY of the following apply: 1)There is a contraindication to montelukast 2)Chronic severe disease which may cause persistent cough (eg cystic fibrosis, bronchiectasis, cardiac failure) 3)Immunodeficiency/immunocompromised state 4)Pregnancy 5)Breastfeeding 6)Current smoker (i.e. stopped smoking less than 6 months ago). 7)Regular medication associated with persistent cough (ACE inhibitors) 8)The individual is in another clinical research study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of montelukast in the treatment of acute persistent cough in young people and adults.;Secondary Objective: 1)To assess the feasibility of performing a double blind randomised placebo controlled trial of montelukast in the treatment of acute persistent cough in young people and adults with whooping cough. 2)To assess the validity of subjective cough outcome measures (diary-recorded paroxysms of cough, cough visual analogue scale score and exercise-related cough score) in relation to objective cough frequency measured using the Leicester Cough Monitor. 3)To compare subsequent intervention rates (re-consultation, investigation, prescription of other medication) in young people and adults with acute persistent cough treated with montelukast versus placebo. 4)To assess the adverse event profile of montelukast in the treatment of acute persistent cough in young people and adults. 5)To examine the relationship between exercise and cough in young people and adults with acute persistent cough. ;Primary end point(s): The primary outcome measure will be change in Leicester Cough Questionnaire (LCQ) total score at 2 and 4 weeks post randomisation. | — |
Countries
United Kingdom
Outcome results
None listed