The Development of Novel Clinical Tests to Diagnose and Monitor Asthma in Preschool Children
NCT ID: NCT02743663
Last Updated: 2021-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
121 participants
OBSERVATIONAL
2014-06-30
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Bronchodilator response
Bronchodilator (Salbutamol - dose dependent on participant prescription) to wheezing subjects. 15 minutes after bronchodilator, spirometry and FOT repeated.
Allergy Skin Test
Child will be tested for allergies to 17 different allergens, and positive (histamine) and negative (glycerin) controls, for a total of 19 allergens.
Multiple-Breath Washout
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.
Forced Oscillation Technique
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.
Spirometry
Forced exhale manoeuvre completed by participant into flow meter, measuring forced exhale volumes and speed.
salbutamol
Given during bronchodilator response.
Nasal Brush
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).
Blood sample
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.
Basophil activation test
Collect basophils from whole blood sample, and expose cells to food allergens in flow cytometry machine to measure allergic response, if any.
Nasal swab
Gentle swabbing of both nasal openings to collect mucous sample for analysis of microbial contents (i.e. bacteria, virus, fungi).
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.
Allergy Skin Test
Child will be tested for allergies to 17 different allergens, and positive (histamine) and negative (glycerin) controls, for a total of 19 allergens.
Multiple-Breath Washout
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.
Forced Oscillation Technique
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.
Spirometry
Forced exhale manoeuvre completed by participant into flow meter, measuring forced exhale volumes and speed.
Interventions
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Bronchodilator response
Bronchodilator (Salbutamol - dose dependent on participant prescription) to wheezing subjects. 15 minutes after bronchodilator, spirometry and FOT repeated.
Allergy Skin Test
Child will be tested for allergies to 17 different allergens, and positive (histamine) and negative (glycerin) controls, for a total of 19 allergens.
Multiple-Breath Washout
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.
Forced Oscillation Technique
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.
Spirometry
Forced exhale manoeuvre completed by participant into flow meter, measuring forced exhale volumes and speed.
salbutamol
Given during bronchodilator response.
Nasal Brush
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).
Blood sample
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.
Basophil activation test
Collect basophils from whole blood sample, and expose cells to food allergens in flow cytometry machine to measure allergic response, if any.
Nasal swab
Gentle swabbing of both nasal openings to collect mucous sample for analysis of microbial contents (i.e. bacteria, virus, fungi).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* 3 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
Exclusion Criteria
* Born pre-term (\< 35 weeks GA)
* Insufficient command of the English language
3 Years
5 Years
ALL
Yes
Sponsors
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Dalhousie University
OTHER
The Hospital for Sick Children
OTHER
Responsible Party
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Padmaja Subbarao
Staff Respirologist
Principal Investigators
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Padmaja Subbarao, MD
Role: PRINCIPAL_INVESTIGATOR
The Hospital for Sick Children
Locations
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The Hospital for Sick Children
Toronto, Ontario, Canada
Countries
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Other Identifiers
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1000041089
Identifier Type: -
Identifier Source: org_study_id
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