Preschool wheeze
Conditions
Interventions
Trade Name: Singulair Granules
Product Name: Montelukast
Pharmaceutical Form: Granules
INN or Proposed INN: Montelukast
CAS Number: 1589
Sponsors
Queen Mary University London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • age = 10 months and = 5 years on the day of the first dose of IMP. • two or more attacks of parent-reported wheeze, • at least one attack with wheeze validated by a clinician • the most recent attack within the last 3 months. • contactable by telephone and able to attend one face-to-face review for issue of IMP • parent or guardian able to give written informed consent for their child participate in the study. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no 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: •• any other chronic respiratory condition diagnosed by a clinician including structural airway abnormality (e.g. floppy larynx) and cystic fibrosis • any chronic condition that increases vulnerability to respiratory tract infection such as severe developmental delay with feeding difficulty • history of neonatal chronic lung disease • current continuous oral montelukast therapy • in a trial using an IMP within the previous 3 months prior to recruitment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The principal objective of this research is to determine whether intermittent parent-initiated treatment with oral montelukast in preschool children with a history of wheeze, reduces the need for unscheduled medical attention for wheeze. To assess this treatment will be started by parents or guardians i) at the onset of every cold and continued for a minimum of 7 days or until wheeze has resolved for 48 hours, and ii) for every episode of wheeze not associated with a viral cold, and stopped when symptoms have resolved for 48 hours. For each child, the trial will last 12 months.; Secondary Objective: Respiratory morbidity • Number of days with parent-reported wheeze over the 12 month trial period • Number of admissions to hospital over the 12 month trial period • Duration of admissions to hospital over the 12 month trial period • Time to first attack of wheeze • Number of unscheduled GP consultations for wheeze • Duration of episodes by diary card • Severity of episodes by diary card • Parent’s overall impression of efficacy of IMP (trial medication) Health service use • Unscheduled GP consultation with exacerbation of wheeze, expressed as time from randomisation to first attendance and annual attendance rate • A&E attendance with wheeze exacerbation, expressed as time from randomisation to first attendance and annual attendance rate • Unscheduled hospital admission with wheeze exacerbation, expressed as time from randomisation to first admission and annual rate of admissions • Total duration of hospital admissions for exacerbation of wheeze Adverse events ; Primary end point(s): The primary outcome measures for this trial is; • Number of times a child attends for an u | — |
Countries
United Kingdom
Outcome results
None listed