An observational study in Asthma, sponsored by Imperial College London. Completed at 1 site in United Kingdom. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2016-02-22.
Sponsored by Imperial College London · Observational
It is increasingly recognised that asthma is not a single disease but that there are many different phenotypes. Much of the work that we have previously carried out has focussed on differentiating children with difficult asthma (those whose asthma control improves with attention to the basics of asthma management such as adherence) from those with severe therapy resistant asthma (ongoing poor control despite high dose treatment and attention to the basics. Our collaborators in Basel, Switzerland have demonstrated that serial measurements of lung function (peak flow) in adults can characterise the severe asthma phenotype and its stability in adults with asthma. We plan to carry out twice daily peak flow measurement sin children with asthma using an electronic peak flow meter. We will analyse peak flow patterns in children with severe therapy resistant asthma (STRA), difficult asthma (DA) and mild to moderate asthma. We will also investigate the relationship between peak flow variations and symptoms, recorded in a daily diary and medication use, recorded by an electronic measuring device which attaches to the child's own inhaler (Smart-inhaler).
Many children present with poorly controlled asthma despite high intensity treatment including high doses of inhaled steroids. A number of these children will get better once the basics of asthma management are addressed (such as adherence, allergen avoidance, smoking cessation). The remainder will need further escalation of treatment (with attendant side effects) and more invasive, investigations. Adults with severe asthma have been found to have differences in the fluctuation patterns of peak flow compared to mild asthmatics. This study will enable us to evaluate whether the same is true in children, enabling us to improve the way we identify children with difficult asthma (DA) and severe therapy resistant asthma (STRA) and whether the difficult asthma: DA group are in fact more similar to the mild/moderate group.
Asthma exacerbations are a serious and concerning problem in children with asthma. This study will enable us to assess whether mathematical modelling of fluctuation patterns can enable us to predict n asthma attack and therefore intervene before it becomes severe or even life threatening. This study will also enable us to investigate the relationship between symptoms, peak flow patterns, exacerbations and adherence to inhaled corticosteroids (ICS) as measured by electronic recording devices (Smart-inhalers).
This is an observational cohort study. If the child and their family are happy to participate in the study the first study visit can take place immediately. If they would like time to consider the study it can be deferred until their next routine attendance at the hospital.
Study visit 1:
Information will be collected relating to past medical history, asthma history and current medications (this information may also be obtained from the case notes).
The following standardised questionnaires will be used: Asthma Control Test, children >12 years (ACT) or Childhood Asthma Control Test, children 6-11years (cACT) (usually completed as part of a routine clinical visit); Mini Paediatric Asthma Quality of Life Questionnaire (PAQLQ); Medicines Adherence Rating Scale (MARS); Beliefs about Medicines Questionnaire (BMQ).
Study procedures:
Lung function (included as part of a routine clinic visit), bronchodilator reversibility (lung function repeated after administration of salbutamol), exhaled nitric oxide.
The child and their family will be issued with a paper diary, electronic peak flow meter (PIKO) and electronic monitoring device for their inhaler (Smart-inhaler) and shown how to use these.
Between visits:
Children will be asked to measure their peak flow twice daily (morning and evening) and record their symptoms in a diary. Their parents will also be asked to complete the diary. They will be contacted by the study investigator to check whether there are any technical problems and as a reminder to make the peak flow measurements and complete the diary.
Visit 2, approximately 12 weeks later (from 8 to 16 weeks)
The second study visit will be scheduled at the time of a planned hospital appointment. This will largely be a repeat of visit 1:
Information will be collected relating to asthma control and exacerbations since visit 1. The following standardised questionnaires will be used: Asthma Control Test, children >12 years (ACT) or Childhood Asthma Control Test, children 6-11years (cACT) (usually completed as part of a routine clinical visit); Mini Paediatric Asthma Quality of Life Questionnaire (PAQLQ)
Study procedures:
Lung function (included as part of a routine clinic visit), bronchodilator reversibility (lung function repeated after administration of salbutamol), exhaled nitric oxide.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 120 is below the median of 150 across 970 observational studies indexed under Asthma.
Browse Asthma studies →Imperial College London is the lead sponsor of 824 studies on the registry; 178 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Children with problematic severe asthma (PSA) will be identified from clinical records and the existing clinical database which records all those who have been assessed as part of the Difficult Asthma (DA) protocol. Children newly referred to the DA protocol will be identified by notification from Clinical Nurse Specialists (CNSs) who receive the referrals. Children with mild-moderate asthma will be identified from clinical records only.
Exclusion Criteria:
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.
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
Dose of inhaled corticosteroids
Time frame: 3 months
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
Adherence as measured by Smart-inhaler data which will be downloaded at the follow up visit
Time frame: 3 months
Plan to share: No
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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Imperial College London