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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
Sponsor:
Collaborators:
Royal Brompton & Harefield NHS Foundation Trust
Swiss National Science Foundation
Information provided by (Responsible Party):
Imperial College London

Brief 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).

Condition or disease
Asthma

Show Show detailed description

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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Group/Cohort
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.



Primary Outcome Measures :
  1. Individual variability in peak expiratory flow [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Individual variability in FEV1 [ Time Frame: 3 months ]
  2. Exacerbations (severe and moderate) [ Time Frame: 3 months ]
  3. Asthma control (asthma control test (ACT) scores ) [ Time Frame: 3 months ]
  4. ICS dose [ Time Frame: 3 months ]
    Dose of inhaled corticosteroids

  5. Asthma related quality of life (paediatric quality of life PAQLQ scores) [ Time Frame: 3 months ]
  6. Lung function (FEV1, bronchodilator reversibility) [ Time Frame: 3 months ]
  7. Adherence [ Time Frame: 3 months ]
    Adherence as measured by Smart-inhaler data which will be downloaded at the follow up visit



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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • Parent / guardian must be able to give written informed consent prior to participation in the study, which includes ability to comply with the requirements and restrictions listed in the consent form. Informed consent must be obtained prior to undertaking any study procedures.
  • Assent should be obtained from all children in the study where appropriate.
  • Male or female subject aged between 5 - 17 years inclusive at screening.
  • The parent / guardian, or where appropriate the child must be able to read, comprehend, and write at a sufficient level to complete study related materials.

Exclusion Criteria:

  1. As a result of medical interview, physical examination or screening investigation the physician responsible considers the child unfit for the study.
  2. Those who, in the opinion of the investigator, have a risk of non-compliance with study procedures.
  3. Significant alternative diagnoses that may mimic or complicate asthma, in particular dysfunctional breathing, panic attacks, and overt psychosocial problems (if these are thought to be the major problem rather than in addition to severe asthma)
  4. Significant other primary pulmonary disorders in particular cystic fibrosis, interstitial lung disease
  5. Participants with bronchiectasis should only be excluded if this is thought to be the major pulmonary disorder rather than in addition to severe asthma

Information from the National Library of Medicine

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


Locations
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United Kingdom
Royal Brompton Hospital
London, United Kingdom, SW36NP
Sponsors and Collaborators
Imperial College London
Royal Brompton & Harefield NHS Foundation Trust
Swiss National Science Foundation
Investigators
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Principal Investigator: Louise Fleming, MD, MBChB Senior Lecturer Paediatric Respiratory Medicine, Imperial College London
Publications:

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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT02252289    
Other Study ID Numbers: 154768
P2SKP3_151971/1 ( Other Grant/Funding Number: Swiss National Science Foundation (SNSF) )
First Posted: September 30, 2014    Key Record Dates
Last Update Posted: February 22, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Imperial College London:
Asthma
children
fluctuation analysis
exacerbations
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases