Fluctuation of Airway Function in Children With Asthma
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|ClinicalTrials.gov Identifier: NCT02252289|
Recruitment Status : Completed
First Posted : September 30, 2014
Last Update Posted : February 22, 2016
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||120 participants|
|Official Title:||Fluctuation of Airway Function in Children With Asthma Phenotype as a Predictor of Outcome|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2015|
Problematic severe asthmatics
Approximately 75 Children aged 5 to 17 years with problematic severe asthma (PSA). Two groups of PSA children will be recruited: those who have already been assessed as part of the Difficult Asthma protocol and classified as DA (difficult asthma)/ STRA (severe therapy resistant asthma) (training set) and those newly referred to the protocol (validation set).
Previous enrolment or new referral to the Royal Brompton Hospital Difficult Asthma Protocol.
Control group of moderate asthmatics
A control group of 30 children aged 5 to 17 years with mild to moderate asthma.
- Individual variability in peak expiratory flow [ Time Frame: 3 months ]
- Individual variability in FEV1 [ Time Frame: 3 months ]
- Exacerbations (severe and moderate) [ Time Frame: 3 months ]
- Asthma control (asthma control test (ACT) scores ) [ Time Frame: 3 months ]
- ICS dose [ Time Frame: 3 months ]Dose of inhaled corticosteroids
- Asthma related quality of life (paediatric quality of life PAQLQ scores) [ Time Frame: 3 months ]
- Lung function (FEV1, bronchodilator reversibility) [ Time Frame: 3 months ]
- Adherence [ Time Frame: 3 months ]Adherence as measured by Smart-inhaler data which will be downloaded at the follow up visit
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02252289
|Royal Brompton Hospital|
|London, United Kingdom, SW36NP|
|Principal Investigator:||Louise Fleming, MD, MBChB||Senior Lecturer Paediatric Respiratory Medicine, Imperial College London|