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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01982162
• Other study ID #: 10/H0801/65
• Status: Completed
• Phase: N/A
• First received: October 30, 2013
• Last updated: June 22, 2015
• Start date: April 2011
• Est. completion date: April 2014

Study information

• Verified date: June 2015
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Sweden: Regional Ethical Review BoardSwitzerland: EthikkommissionUnited Kingdom: Research Ethics Committee
• Study type: Observational

Clinical 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: April 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 17 Years

Eligibility

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).

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma exacerbations		3 years	No
Primary	Lung function decline over the course of the study		3 years	No
Primary	Changes in asthma medication		3 years	No
Primary	Daily symptoms and short acting beta agonist (SABA) usage		3 years	No
Primary	Asthma control questionnaire (ACQ) at baseline and changes over the course of the study		3 years	No
Primary	Upper airway symptoms as assessed by the sino-nasal outcomes test (SNOT) at baseline and changes over the course of the study		3 years	No
Primary	Sleep and daytime drowsiness as assessed by the Epworth sleepiness scale at baseline and changes over the course of the study		3 years	No
Primary	Measurement of pulmonary function including spirometry, plethysmography, bronchodilator reversibility and respiratory impedance by forced oscillation technique		3 years	No
Primary	Radiological parameters such as computerized tomography (CT) scan, including assessment of lung structure		3 years	No
Primary	Measurement of inflammatory cell counts in blood, sputum and bronchoalveolar lavage (BAL)		3 years	No
Primary	Histopathology of bronchial biopsies in a sub group of subjects		3 years	No
Primary	Transcriptomics, proteomics and metabolomics will be used on samples such as blood, urine and endobronchial biopsies		3 years	No
Primary	Quality of life as assessed by the asthma quality of life questionnaire (AQLQ)		3 years	No
Primary	Anxiety and depression as assessed by the hospital anxiety and depression scale (HADS)		3 years	No