Fluctuation of Airway Function in Children With Asthma

NCT02252289 | Completed

• 2 other identifiers: 154768P2SKP3_151971/1
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

Asthma

Keywords

Asthma; children; fluctuation analysis; exacerbations

Outcome Measures

Primary Outcomes (1)

• Individual variability in peak expiratory flow

  3 months

Secondary Outcomes (7)

• Individual variability in FEV1

  3 months

• Exacerbations (severe and moderate)

  3 months

• Asthma control (asthma control test (ACT) scores )

  3 months

• ICS dose

  3 months

• Asthma related quality of life (paediatric quality of life PAQLQ scores)

  3 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• Royal Brompton & Harefield NHS Foundation Trust: collaborator
• Swiss National Science Foundation: collaborator

Study Sites (1)

Royal Brompton Hospital

London, SW36NP, United Kingdom

Location

Related Publications (7)

• 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.

  PMID: 14713908 BACKGROUND

• Liu 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.

  PMID: 17353040 BACKGROUND

• Juniper 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.

  PMID: 8901365 BACKGROUND

• Cohen 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.

  PMID: 19852197 BACKGROUND

• Menckeberg 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.

  PMID: 18157999 BACKGROUND

• Frey 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.

  PMID: 16319891 BACKGROUND

• Bracken 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.

  PMID: 19546102 BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Louise Fleming, MD, MBChB

  Senior Lecturer Paediatric Respiratory Medicine, Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2014
• First Posted: September 30, 2014
• Study Start: September 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: February 22, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)