Parent-determined oral montelukast therapy for preschool wheeze with stratification for arachidonate-5-lipoxygenase (ALOX5) promoter genotype. - Wheeze And Intermittent Treatment; WAIT
- Conditions
- Preschool wheeze
- Registration Number
- EUCTR2009-015626-11-GB
- Lead Sponsor
- Queen Mary University London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 1346
•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
••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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method