Recurrent wheeze in preschool children MedDRA version: 19.0 Level: LLT Classification code 10047921 Term: Wheeze System Organ Class: 100000004855
Conditions
Interventions
Product Name: Salbutamol
Pharmaceutical Form: Inhalation vapour
INN or Proposed INN: Salbutamol Sulphate
Concentration unit: µg microgram(s)
Sponsors
Brighton and Sussex University Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age 2 years 6 months to 6 years 11 months - Recurrent wheeze, defined as at least 3 episodes of wheeze over the previous 12 months by the parent. Are the trial subjects under 18? yes Number of subjects for this age range: 155 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: - Other major airway or lung disease, e.g. chronic lung disease of prematurity, cystic fibrosis, and abnormal airway anatomy. - Long acting beta-2 agonists within 1 week of the study visit - Recent (within 2 weeks) treatment with systemic corticosteroids or leukotriene inhibitors. - Involved in a drug study within the last 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The principal research question this work will address is: Can we define the dose of inhaled salbutamol that is appropriate for 3-7 year old children with recurrent wheeze? ; Secondary Objective: Can we predict the salbutamol dose that is appropriate for an individual child using simple, non-invasive and inexpensive tests that can be performed in the outpatient setting? ;Primary end point(s): Bronchodilator response to salbutamol.;Timepoint(s) of evaluation of this end point: 15 minutes after each salbutamol dose | — |
Countries
United Kingdom
Contacts
Public ContactScott Harfield
Brighton and Sussex University Hospitals NHS Trust
Outcome results
None listed