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Completed

NCT Number: NCT01982162

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

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Key information

Conditions

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

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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.

Exclusion criteria

  • 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
  • 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).

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Nov 13, 2013
Registry last updated
Jun 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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