The Development of Novel Clinical Tests to Diagnose and Monitor Asthma in Preschool Children
WheezyER
1 other identifier
observational
121
1 country
1
Brief Summary
The study will ascertain the ability of preschool lung function tests to distinguish healthy children from those with wheeze, and to differentiate phenotypes of wheezy children (high and low risk for asthma as defined by API) in order to predict response to therapy, and to explore the correlation between preschool lung function test results and symptoms, in order to develop objective methods for monitoring asthma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 13, 2016
CompletedFirst Posted
Study publicly available on registry
April 19, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedFebruary 8, 2021
February 1, 2021
6.5 years
January 13, 2016
February 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Lung Clearance Index (LCI) in wheezing subjects.
Determine whether a change in LCI value captured over a 3 month period distinguishes two groups of wheezing children (high vs. low risk for asthma) as determined by the asthma predictive index (API).
baseline and 3 months
Secondary Outcomes (11)
Obstructive Sleep Apnea (OSA)
Day 1, and again 3 months later.
Change in asthma symptoms
baseline and 3 months
Change in Forced Oscillation Technique (FOT) values in wheezing subjects.
baseline and 3 months
Change in spirometry values in wheezing subjects.
baseline and 3 months
Comparison of LCI values between wheezy subjects and healthy controls.
Day 1 for wheezing subjects and healthy controls, and again 3 months later for wheezing subjects.
- +6 more secondary outcomes
Study Arms (2)
Wheezing subjects
Two study visits will be completed with wheezing subjects. The baseline visit will be completed within a 5 day window from the child's discharge from the emergency department. The follow-up visit will be completed 3 months after the baseline visit. At both visits, participants will provide a nasal swab and urine sample, complete three breathing tests: multiple-breath washout, forced oscillation technique, and Spirometry. In addition, at the follow-up visit, children will have an allergy skin test done, a nasal brush to collect epithelial cells and provide a blood sample. Whole blood will be used for basophil activation test (BAT). Children age 4+ will also complete post-bronchodilator testing using Salbutamol to capture information about bronchodilator response.
Healthy cohort
One study visit will be completed with healthy participants. At this visit, three breathing tests will be performed: multiple-breath washout, forced oscillation technique, and spirometry. As well, an allergy skin test will be performed at the visit.
Interventions
Bronchodilator (Salbutamol - dose dependent on participant prescription) to wheezing subjects. 15 minutes after bronchodilator, spirometry and FOT repeated.
Child will be tested for allergies to 17 different allergens, and positive (histamine) and negative (glycerin) controls, for a total of 19 allergens.
Facemask in children 3-5 yrs, Wash-in phase: medical air inhaled during tidal breathing until steady state. Bias flow switched to 100% oxygen. Wash-out phase: patient breathes in 100% oxygen until nitrogen levels reach \~2%. Each test in duplicate and average is calculated.
Sterile mouthpiece attached to FOT device. Patient is tested seated with noseclips and mouthpiece. FOT device produces oscillations at different frequencies (from that flow into lungs. Device measures resistance and reactance in lungs.
Forced exhale manoeuvre completed by participant into flow meter, measuring forced exhale volumes and speed.
Nasal brush of 1 inferior turbinate to collect epithelial cells. Collected on either nare, choice dependent on how clear the nare is (i.e. no mucous, no nasal mucosal edema, no major structural impediments).
8mLs of venous blood collected using a butterfly needle of appropriate gauge. Blood sample used to collect CBC values, total IgE, serum, DNA, plasma, and whole blood.
Collect basophils from whole blood sample, and expose cells to food allergens in flow cytometry machine to measure allergic response, if any.
Gentle swabbing of both nasal openings to collect mucous sample for analysis of microbial contents (i.e. bacteria, virus, fungi).
Eligibility Criteria
Wheezing preschool-aged subjects will be recruited within 5 days of their discharge from the Emergency Department at the Hospital for Sick Children. Healthy preschool-aged controls will be recruited from the community (concurrent observational studies being conducted by the PI at the Hospital for Sick Children, children of co-workers)
You may qualify if:
- to 5 years of age (36 to 71 months)
- Diagnosis of Asthma made by a physician in the emergency department
- History of at least two other wheezing episode within the previous 12 months
- Received salbutamol within 4hrs before emergency department visit, during current emergency department visit, or was prescribed salbutamol at discharge from emergency department.
- to 5 years of age (36 to 71 months)
- Free of a respiratory infection for a minimum of 4 weeks prior to the testing visit
You may not qualify if:
- History or coexistence of renal, chronic pulmonary, cardiac, neurological or systemic disease
- Born pre-term (\< 35 weeks GA)
- Insufficient command of the English language
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Hospital for Sick Childrenlead
- Dalhousie Universitycollaborator
Study Sites (1)
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
Biospecimen
Venous blood samples collected and divided into DNA pellet, plasma, serum, and whole blood. Small portion of sample sent for Total IgE and CBC. The eosinophil and IgE information will be used to assist with categorizing wheezy subjects into API categories. The DNA sample will be analyzed using genome-wide association studies (GWAS), and looking for single-nucleotide polymorphism (SNPs) that are known to be associated with asthma. The whole blood samples will be used for the basophil activation test; Urine samples; Nasal swab samples; Nasal brush samples;
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Padmaja Subbarao, MD
The Hospital for Sick Children
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Staff Respirologist
Study Record Dates
First Submitted
January 13, 2016
First Posted
April 19, 2016
Study Start
June 1, 2014
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
February 8, 2021
Record last verified: 2021-02