Status:
COMPLETED
Wheeze and Intermittent Treatment
Lead Sponsor:
Queen Mary University of London
Collaborating Sponsors:
University of Aberdeen
University of Leicester
Conditions:
Wheezing
Eligibility:
All Genders
10-5 years
Phase:
PHASE3
Brief Summary
The clinical aim of this trial is to assess whether intermittent montelukast is an effective treatment strategy in preschool wheeze. The mechanisms aim of the trial is to determine whether there is a ...
Detailed Description
Background A quarter of all UK children will have at least one attack of wheeze during the preschool period (1 to 5 years of age). Severe attacks of wheeze in these young children are usually trigger...
Eligibility Criteria
Inclusion
- age ≥ 10 months and ≤ 5 years old on the day of the first dose of Investigational Medicinal Product
- 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 Investigational Medicinal Product
- parent or guardian able to give written informed consent for their child to participate in the study
Exclusion
- 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 Investigational Medicinal Product in the previous 3 months prior to recruitment
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
1358 Patients enrolled
Trial Details
Trial ID
NCT01142505
Start Date
November 1 2010
End Date
February 1 2014
Last Update
April 29 2014
Active Locations (1)
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1
Barts and the London NHS Trust
London, United Kingdom, E1 1BB