AsthmaNCT02252289
Fluctuation of Airway Function in Children With Asthma
An observational study of Asthma, run by Imperial College London at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Asthma
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2014to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- As a result of medical interview, physical examination or screening investigation the physician responsible considers the child unfit for the study.
- Those who, in the opinion of the investigator, have a risk of non-compliance with study procedures.
- 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)
- Significant other primary pulmonary disorders in particular cystic fibrosis, interstitial lung disease
- Participants with bronchiectasis should only be excluded if this is thought to be the major pulmonary disorder rather than in addition to severe asthma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fluctuation of Airway Function in Children With Asthma Phenotype as a Predictor of Outcome
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).
Read the 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.
- Conditions
- Asthma
- Keywords
- Asthma, children, fluctuation analysis, exacerbations
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Individual variability in peak expiratory flow
Measured: 3 months
Secondary outcomes (7)
Individual variability in FEV1
Measured: 3 months
Exacerbations (severe and moderate)
Measured: 3 months
Asthma control (asthma control test (ACT) scores )
Measured: 3 months
ICS dose
Dose of inhaled corticosteroids
Measured: 3 months
Asthma related quality of life (paediatric quality of life PAQLQ scores)
Measured: 3 months
Lung function (FEV1, bronchodilator reversibility)
Measured: 3 months
Adherence
Adherence as measured by Smart-inhaler data which will be downloaded at the follow up visit
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Brompton & Harefield NHS Foundation Trust, Swiss National Science Foundation
- Responsible party
- Sponsor
- Investigators
- Louise Fleming, MD, MBChB, Principal investigator, Senior Lecturer Paediatric Respiratory Medicine, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02252289
- Sponsor's protocol ID
- 154768
- Other IDs
- P2SKP3_151971/1
- Status last verified
- Feb 2016
- First submitted
- 26 Sep 2014
- Last updated
- 22 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Nathan RA, Sorkness CA, Kosinski M, Schatz M, Li JT, Marcus P, Murray JJ, Pendergraft TB. Development of the asthma control test: a survey for assessing asthma control. J Allergy Clin Immunol. 2004 Jan;113(1):59-65. doi: 10.1016/j.jaci.2003.09.008.
PubMed 14713908Liu AH, Zeiger R, Sorkness C, Mahr T, Ostrom N, Burgess S, Rosenzweig JC, Manjunath R. Development and cross-sectional validation of the Childhood Asthma Control Test. J Allergy Clin Immunol. 2007 Apr;119(4):817-25. doi: 10.1016/j.jaci.2006.12.662. Epub 2007 Mar 13.
PubMed 17353040Juniper EF, Guyatt GH, Feeny DH, Ferrie PJ, Griffith LE, Townsend M. Measuring quality of life in children with asthma. Qual Life Res. 1996 Feb;5(1):35-46. doi: 10.1007/BF00435967.
PubMed 8901365Cohen JL, Mann DM, Wisnivesky JP, Home R, Leventhal H, Musumeci-Szabo TJ, Halm EA. Assessing the validity of self-reported medication adherence among inner-city asthmatic adults: the Medication Adherence Report Scale for Asthma. Ann Allergy Asthma Immunol. 2009 Oct;103(4):325-31. doi: 10.1016/s1081-1206(10)60532-7.
PubMed 19852197Menckeberg TT, Bouvy ML, Bracke M, Kaptein AA, Leufkens HG, Raaijmakers JA, Horne R. Beliefs about medicines predict refill adherence to inhaled corticosteroids. J Psychosom Res. 2008 Jan;64(1):47-54. doi: 10.1016/j.jpsychores.2007.07.016.
PubMed 18157999Frey U, Brodbeck T, Majumdar A, Taylor DR, Town GI, Silverman M, Suki B. Risk of severe asthma episodes predicted from fluctuation analysis of airway function. Nature. 2005 Dec 1;438(7068):667-70. doi: 10.1038/nature04176.
PubMed 16319891Bracken M, Fleming L, Hall P, Van Stiphout N, Bossley C, Biggart E, Wilson NM, Bush A. The importance of nurse-led home visits in the assessment of children with problematic asthma. Arch Dis Child. 2009 Oct;94(10):780-4. doi: 10.1136/adc.2008.152140. Epub 2009 Jun 21.
PubMed 19546102
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluctuation of Airway Function in Children With Asthma Phenotype as a Predictor of Outcome
- ClinicalTrials.gov ID
- NCT02252289
- Acronym / sponsor ID
- 154768
- Conditions
- Asthma
- Keywords
- Asthma, children, fluctuation analysis, exacerbations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Royal Brompton & Harefield NHS Foundation Trust, Swiss National Science Foundation
- Study start
- Sep 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 30 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- As a result of medical interview, physical examination or screening investigation the physician responsible considers the child unfit for the study.
- Those who, in the opinion of the investigator, have a risk of non-compliance with study procedures.
- 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)
- Significant other primary pulmonary disorders in particular cystic fibrosis, interstitial lung disease
- Participants with bronchiectasis should only be excluded if this is thought to be the major pulmonary disorder rather than in addition to severe asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Individual variability in peak expiratory flow
Time frame: 3 months
7 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2016.
- Background: PubMed 14713908Nathan RA, Sorkness CA, Kosinski M, Schatz M, Li JT, Marcus P, Murray JJ, Pendergraft TB. Development of the asthma control test: a survey for assessing asthma control. J Allergy Clin Immunol. 2004 Jan;113(1):59-65. doi: 10.1016/j.jaci.2003.09.008.
- Background: PubMed 17353040Liu AH, Zeiger R, Sorkness C, Mahr T, Ostrom N, Burgess S, Rosenzweig JC, Manjunath R. Development and cross-sectional validation of the Childhood Asthma Control Test. J Allergy Clin Immunol. 2007 Apr;119(4):817-25. doi: 10.1016/j.jaci.2006.12.662. Epub 2007 Mar 13.
- Background: PubMed 8901365Juniper EF, Guyatt GH, Feeny DH, Ferrie PJ, Griffith LE, Townsend M. Measuring quality of life in children with asthma. Qual Life Res. 1996 Feb;5(1):35-46. doi: 10.1007/BF00435967.
- Background: PubMed 19852197Cohen JL, Mann DM, Wisnivesky JP, Home R, Leventhal H, Musumeci-Szabo TJ, Halm EA. Assessing the validity of self-reported medication adherence among inner-city asthmatic adults: the Medication Adherence Report Scale for Asthma. Ann Allergy Asthma Immunol. 2009 Oct;103(4):325-31. doi: 10.1016/s1081-1206(10)60532-7.
- Background: PubMed 18157999Menckeberg TT, Bouvy ML, Bracke M, Kaptein AA, Leufkens HG, Raaijmakers JA, Horne R. Beliefs about medicines predict refill adherence to inhaled corticosteroids. J Psychosom Res. 2008 Jan;64(1):47-54. doi: 10.1016/j.jpsychores.2007.07.016.
- Background: PubMed 16319891Frey U, Brodbeck T, Majumdar A, Taylor DR, Town GI, Silverman M, Suki B. Risk of severe asthma episodes predicted from fluctuation analysis of airway function. Nature. 2005 Dec 1;438(7068):667-70. doi: 10.1038/nature04176.
- Background: PubMed 19546102Bracken M, Fleming L, Hall P, Van Stiphout N, Bossley C, Biggart E, Wilson NM, Bush A. The importance of nurse-led home visits in the assessment of children with problematic asthma. Arch Dis Child. 2009 Oct;94(10):780-4. doi: 10.1136/adc.2008.152140. Epub 2009 Jun 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louise Fleming, MD, MBChB principal investigator
Senior Lecturer Paediatric Respiratory Medicine, Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Individual variability in peak expiratory flow (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02252289, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2016; AzTrials last refreshed its copy on 6 Nov 2026.