Optimising salbutamol dose for wheezy preschool childre
Phase 1
- Conditions
- Recurrent wheeze in preschool childrenMedDRA version: 19.0 Level: LLT Classification code 10047921 Term: Wheeze System Organ Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2014-001978-33-GB
- Lead Sponsor
- Brighton and Sussex University Hospitals NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 156
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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Main Objective: The principal research question this work will address is:<br><br> Can we define the dose of inhaled salbutamol that is appropriate for 3-7 year old children with recurrent wheeze?<br><br> ;<br> 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?<br><br> ;Primary end point(s): Bronchodilator response to salbutamol.;Timepoint(s) of evaluation of this end point: 15 minutes after each salbutamol dose
- Secondary Outcome Measures
Name Time Method