Fluctuation of Airway Function in Children With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      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).
    

Detailed description: 
      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.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        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.
      
Keywords: Asthma; children; fluctuation analysis; exacerbations