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AsthmaNCT01982162

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

An observational study of Asthma, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 1 year to 17 years
Conditions the study is for
Asthma
How many people
300 participants
Where
No sites listed yet
Study dates
Apr 2011to Apr 2014
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 1 year to 17 years
  • All sexes
  • No healthy volunteers
  • Child

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

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 1 - 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.
  • 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.

Who cannot join

  • As a result of medical interview, physical examination or screening investigation the physician responsible considers the child unfit for the study.
  • The subject has a history of drug or other allergy, which, in the opinion of the responsable physician, contra-indicates their participation.
  • 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
  • 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.
  • Those who, in the opinion of the investigator, have a risk of non-compliance with study procedures.
  • Prematurity ≤35 weeks gestation
Show all 9Show fewer
  • 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)
  • 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).
  • 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).

About this study

Official title: Protocol for the European Multi-Centre Study Understanding Severe Asthma Longitudinal Assessment of Children With Severe Asthma and Severe Pre-school Wheeze

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

Conditions
Asthma
Keywords
Sputum, Clinical cohorts, Smokers, Asthma, Biopsies, Severe asthma, Collaborative research, Phenotyping, Lipidomics, Transcriptomics, Proteomics, Paediatric cohort, Systems Biology
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01982162
Study groupRoleWhat they receive
Cohort Asevere school aged asthma cohort
Cohort Bmild to moderate school aged asthma cohort
Cohort CSevere pre school wheeze cohort
Cohort DMild to moderate pre school wheeze cohort

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Asthma exacerbations

    Measured: 3 years

  2. Lung function decline over the course of the study

    Measured: 3 years

  3. Changes in asthma medication

    Measured: 3 years

  4. Daily symptoms and short acting beta agonist (SABA) usage

    Measured: 3 years

  5. Asthma control questionnaire (ACQ) at baseline and changes over the course of the study

    Measured: 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

    Measured: 3 years

  7. Sleep and daytime drowsiness as assessed by the Epworth sleepiness scale at baseline and changes over the course of the study

    Measured: 3 years

  8. Measurement of pulmonary function including spirometry, plethysmography, bronchodilator reversibility and respiratory impedance by forced oscillation technique

    Measured: 3 years

  9. Radiological parameters such as computerized tomography (CT) scan, including assessment of lung structure

    Measured: 3 years

  10. Measurement of inflammatory cell counts in blood, sputum and bronchoalveolar lavage (BAL)

    Measured: 3 years

  11. Histopathology of bronchial biopsies in a sub group of subjects

    Measured: 3 years

  12. Transcriptomics, proteomics and metabolomics will be used on samples such as blood, urine and endobronchial biopsies

    Measured: 3 years

  13. Quality of life as assessed by the asthma quality of life questionnaire (AQLQ)

    Measured: 3 years

  14. Anxiety and depression as assessed by the hospital anxiety and depression scale (HADS)

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2013 (estimated)
  2. Study startApr 2011
  3. Primary completionNov 2013
  4. Study completionApr 2014

Resources

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
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01982162
Sponsor's protocol ID
10/H0801/65
Status last verified
Jun 2015
First submitted
30 Oct 2013
Last updated
24 Jun 2015
Results posted
No
Data monitoring committee
No

Publications

  • Song WJ, Kermani NZ, Versi A, Sanchez-Ovando S, Simpson JL, Wark PA, Baines KJ, Dahlen SE, Djukanovic R, Guo Y, Adcock IM, Chung KF; U-BIOPRED Study Group. Clinical Features of Cellular Senescence Pathways in Severe Asthma. Allergy. 2026 Jun 18. doi: 10.1111/all.70416. Online ahead of print.

    PubMed 42315480

  • Daud T, Roberts S, Zounemat Kermani N, Richardson M, Heaney LG, Adcock IM, Amrani Y, Bradding P, Siddiqui S. The Role of WNT5a and TGF-beta1 in Airway Remodelling and Severe Asthma. Allergy. 2025 Apr;80(4):1025-1037. doi: 10.1111/all.16445. Epub 2025 Jan 3.

    PubMed 39749571

  • Rossios C, Pavlidis S, Hoda U, Kuo CH, Wiegman C, Russell K, Sun K, Loza MJ, Baribaud F, Durham AL, Ojo O, Lutter R, Rowe A, Bansal A, Auffray C, Sousa A, Corfield J, Djukanovic R, Guo Y, Sterk PJ, Chung KF, Adcock IM; Unbiased Biomarkers for the Prediction of Respiratory Diseases Outcomes (U-BIOPRED) Consortia Project Team. Sputum transcriptomics reveal upregulation of IL-1 receptor family members in patients with severe asthma. J Allergy Clin Immunol. 2018 Feb;141(2):560-570. doi: 10.1016/j.jaci.2017.02.045. Epub 2017 May 18.

    PubMed 28528200

  • Loza MJ, Djukanovic R, Chung KF, Horowitz D, Ma K, Branigan P, Barnathan ES, Susulic VS, Silkoff PE, Sterk PJ, Baribaud F; ADEPT (Airways Disease Endotyping for Personalized Therapeutics) and U-BIOPRED (Unbiased Biomarkers for the Prediction of Respiratory Disease Outcome Consortium) investigators. Validated and longitudinally stable asthma phenotypes based on cluster analysis of the ADEPT study. Respir Res. 2016 Dec 15;17(1):165. doi: 10.1186/s12931-016-0482-9.

    PubMed 27978840

  • Bigler J, Boedigheimer M, Schofield JPR, Skipp PJ, Corfield J, Rowe A, Sousa AR, Timour M, Twehues L, Hu X, Roberts G, Welcher AA, Yu W, Lefaudeux D, Meulder B, Auffray C, Chung KF, Adcock IM, Sterk PJ, Djukanovic R; U-BIOPRED Study Group ||. A Severe Asthma Disease Signature from Gene Expression Profiling of Peripheral Blood from U-BIOPRED Cohorts. Am J Respir Crit Care Med. 2017 May 15;195(10):1311-1320. doi: 10.1164/rccm.201604-0866OC.

    PubMed 27925796

  • Fleming L, Murray C, Bansal AT, Hashimoto S, Bisgaard H, Bush A, Frey U, Hedlin G, Singer F, van Aalderen WM, Vissing NH, Zolkipli Z, Selby A, Fowler S, Shaw D, Chung KF, Sousa AR, Wagers S, Corfield J, Pandis I, Rowe A, Formaggio E, Sterk PJ, Roberts G; U-BIOPRED Study Group. The burden of severe asthma in childhood and adolescence: results from the paediatric U-BIOPRED cohorts. Eur Respir J. 2015 Nov;46(5):1322-33. doi: 10.1183/13993003.00780-2015. Epub 2015 Sep 24.

    PubMed 26405287

  • 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, Dahlen 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, Horvath I, Knox AJ, Krug N, Erpenbeck VJ, Larsson LX, Lazarinis N, Matthews JG, Middelveld R, Montuschi P, Musial J, Myles D, Pahus L, Sandstrom 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.

    PubMed 26357963

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).

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 5 inclusion and 9 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 24 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

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?

Asthma exacerbations (time frame: 3 years). The study lists 14 primary outcomes in all. 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 NCT01982162, 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 24 Jun 2015.

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