The Development of Novel Clinical Tests to Diagnose and Monitor Asthma in Preschool Children

CompletedOBSERVATIONAL
Enrollment

121

Participants

Timeline

Start Date

June 30, 2014

Primary Completion Date

December 31, 2020

Study Completion Date

December 31, 2020

Conditions
AsthmaWheezeObstructive Sleep ApneaFood AllergyVirus
Interventions
PROCEDURE

Bronchodilator response

Bronchodilator (Salbutamol - dose dependent on participant prescription) to wheezing subjects. 15 minutes after bronchodilator, spirometry and FOT repeated.

PROCEDURE

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.

PROCEDURE

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.

PROCEDURE

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.

PROCEDURE

Spirometry

Forced exhale manoeuvre completed by participant into flow meter, measuring forced exhale volumes and speed.

DRUG

salbutamol

Given during bronchodilator response.

PROCEDURE

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).

PROCEDURE

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.

PROCEDURE

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.

PROCEDURE

Nasal swab

Gentle swabbing of both nasal openings to collect mucous sample for analysis of microbial contents (i.e. bacteria, virus, fungi).

Trial Locations (1)

M5G 1X8

The Hospital for Sick Children, Toronto

All Listed Sponsors
collaborator

Dalhousie University

OTHER

lead

The Hospital for Sick Children

OTHER

NCT02743663 - The Development of Novel Clinical Tests to Diagnose and Monitor Asthma in Preschool Children | Biotech Hunter | Biotech Hunter