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Longitudinal Assessment of Children With Severe Asthma and Severe Pre-school Wheeze

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ClinicalTrials.gov Identifier: NCT01982162
Recruitment Status : Completed
First Posted : November 13, 2013
Last Update Posted : June 24, 2015
Sponsor:
Information provided by (Responsible Party):
Prof. dr. P.J. Sterk, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary:
Cross-sectional study to characterize cohorts of children with asthma and healthy controls in terms of clinical features, physiological measurements and non-invasive measurement of biomarkers and develop phenotype handprints for children with severe asthma

Condition or disease
Asthma

Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Protocol for the European Multi-Centre Study Understanding Severe Asthma Longitudinal Assessment of Children With Severe Asthma and Severe Pre-school Wheeze
Study Start Date : April 2011
Actual Primary Completion Date : November 2013
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


Group/Cohort
Cohort A
severe school aged asthma cohort
Cohort B
mild to moderate school aged asthma cohort
Cohort C
Severe pre school wheeze cohort
Cohort D
Mild to moderate pre school wheeze cohort



Primary Outcome Measures :
  1. Asthma exacerbations [ Time Frame: 3 years ]
  2. Lung function decline over the course of the study [ Time Frame: 3 years ]
  3. Changes in asthma medication [ Time Frame: 3 years ]
  4. Daily symptoms and short acting beta agonist (SABA) usage [ Time Frame: 3 years ]
  5. Asthma control questionnaire (ACQ) at baseline and changes over the course of the study [ Time Frame: 3 years ]
  6. Upper airway symptoms as assessed by the sino-nasal outcomes test (SNOT) at baseline and changes over the course of the study [ Time Frame: 3 years ]
  7. Sleep and daytime drowsiness as assessed by the Epworth sleepiness scale at baseline and changes over the course of the study [ Time Frame: 3 years ]
  8. Measurement of pulmonary function including spirometry, plethysmography, bronchodilator reversibility and respiratory impedance by forced oscillation technique [ Time Frame: 3 years ]
  9. Radiological parameters such as computerized tomography (CT) scan, including assessment of lung structure [ Time Frame: 3 years ]
  10. Measurement of inflammatory cell counts in blood, sputum and bronchoalveolar lavage (BAL) [ Time Frame: 3 years ]
  11. Histopathology of bronchial biopsies in a sub group of subjects [ Time Frame: 3 years ]
  12. Transcriptomics, proteomics and metabolomics will be used on samples such as blood, urine and endobronchial biopsies [ Time Frame: 3 years ]
  13. Quality of life as assessed by the asthma quality of life questionnaire (AQLQ) [ Time Frame: 3 years ]
  14. Anxiety and depression as assessed by the hospital anxiety and depression scale (HADS) [ Time Frame: 3 years ]


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Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  • Severe school aged asthma cohort: persistent symptoms or frequent severe exacerbations or persistent airflow limitation
  • Mild-moderate school aged asthma cohort: controlled or partially controlled asthma symtomps
  • Severe pre school wheeze cohort: persistent symptoms or frequent severe exacerbations
  • Mild-moderate pre school wheeze cohort: controlled symptoms or partially controlled
Criteria

Inclusion Criteria:

  1. 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.
  2. Assent should be obtained from all children in the study where appropriate.
  3. Male or female subject aged between 1 - 17 years inclusive at screening.
  4. 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.
  5. Subjects will be allowed to enrol in other studies while taking part on this study. However, Permission from the Scientific Board must be obtained to enrol or allow the continued participation of a subject enrolled in another study.

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. The subject has a history of drug or other allergy, which, in the opinion of the responsable physician, contra-indicates their participation.
  3. Subject is female who is pregnant or lactating or up to 6 weeks post partum or 6 weeks cessation of breast feeding. If a woman is subsequently found to have been pregnant at the time of an assessment data from that assessment will not be included in the analyses
  4. The child has participated within 3 months of the first dose in a study using a new molecular entity, or the first dose in any other study investigating drugs or having participated within three months in a study with invasive procedures. Any U-BIOPRED assessments should be deferred until 3 months after the first dose or invasive procedure. Permission from the Scientific Board must be obtained to enroll or allow the continued participation of a child enrolled in another study.
  5. Those who, in the opinion of the investigator, have a risk of non-compliance with study procedures.
  6. Prematurity ≤35 weeks gestation
  7. The child had changed asthma medication within 4 weeks of the screening assessment(except those using the Symbicort maintenance and reliever therapy (SMART) regime)(assessment should be deferred)
  8. History or current evidence of an upper or lower respiratory infection or symptoms (including common cold) within 2 weeks of baseline assessment (assessment should be deferred).
  9. The child has had a severe exacerbation (requiring ER attendance or hospital admission and/or a course of high dose OCS for at least 3 days duration) within 4 weeks of the baseline assessment (assessment should be deferred).

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): NCT01982162


Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
Principal Investigator: Hans Bisgaard, Dr. Copenhaguen Unversity Hospital, Copenhaguen, Denmark
Principal Investigator: Gunila Hedlin, Dr. Astrid Lindgren Children's Hospital, Stockholm, Sweeden
Principal Investigator: Philip Latzin, Dr. Department Respiratory medicine Pediatrics Insespital University of Bern, Bern, Switzerland
Principal Investigator: Peter Sterk, Dr. Academic Medical Centre University of Amsterdam, Amsterdam, The Netherlands
Principal Investigator: Andrew Bush, Dr. Imperial College of London, London, UK
Principal Investigator: Graham Roberts, Dr. Southampton General Hospital, Southampton, UK
Principal Investigator: Claire Murray, Dr. Wythenshawe Hospital, Manchester, UK

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Shaw DE, Sousa AR, Fowler SJ, Fleming LJ, Roberts G, Corfield J, Pandis I, Bansal AT, Bel EH, Auffray C, Compton CH, Bisgaard H, Bucchioni E, Caruso M, Chanez P, Dahlén B, Dahlen SE, Dyson K, Frey U, Geiser T, Gerhardsson de Verdier M, Gibeon D, Guo YK, Hashimoto S, Hedlin G, Jeyasingham E, Hekking PP, Higenbottam T, Horváth I, Knox AJ, Krug N, Erpenbeck VJ, Larsson LX, Lazarinis N, Matthews JG, Middelveld R, Montuschi P, Musial J, Myles D, Pahus L, Sandström T, Seibold W, Singer F, Strandberg K, Vestbo J, Vissing N, von Garnier C, Adcock IM, Wagers S, Rowe A, Howarth P, Wagener AH, Djukanovic R, Sterk PJ, Chung KF; U-BIOPRED Study Group. Clinical and inflammatory characteristics of the European U-BIOPRED adult severe asthma cohort. Eur Respir J. 2015 Nov;46(5):1308-21. doi: 10.1183/13993003.00779-2015. Epub 2015 Sep 10. Erratum in: Eur Respir J. 2017 Jun 22;49(6):.

Responsible Party: Prof. dr. P.J. Sterk, Prof. dr., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT01982162     History of Changes
Other Study ID Numbers: 10/H0801/65
First Posted: November 13, 2013    Key Record Dates
Last Update Posted: June 24, 2015
Last Verified: June 2015

Keywords provided by Prof. dr. P.J. Sterk, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Sputum
Clinical cohorts
Smokers
Asthma
Biopsies
Severe asthma
Collaborative research
Phenotyping
Lipidomics
Transcriptomics
Proteomics
Paediatric cohort
Systems Biology

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases