- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02743663
The Development of Novel Clinical Tests to Diagnose and Monitor Asthma in Preschool Children (WheezyER)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G 1X8
- The Hospital For Sick Children
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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)
Description
Inclusion Criteria (Wheezing Subjects):
- 3 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.
Inclusion Criteria (Healthy Controls):
- 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 (both subjects and controls):
- History or coexistence of renal, chronic pulmonary, cardiac, neurological or systemic disease
- Born pre-term (< 35 weeks GA)
- Insufficient command of the English language
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
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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.
Other Names:
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.
Other Names:
Forced exhale manoeuvre completed by participant into flow meter, measuring forced exhale volumes and speed.
Given during bronchodilator response.
Other Names:
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.
Other Names:
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.
|
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.
Other Names:
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.
Other Names:
Forced exhale manoeuvre completed by participant into flow meter, measuring forced exhale volumes and speed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Lung Clearance Index (LCI) in wheezing subjects.
Time Frame: baseline and 3 months
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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).
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baseline and 3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Obstructive Sleep Apnea (OSA)
Time Frame: Day 1, and again 3 months later.
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Obstructive sleep apnea symptoms in wheezing preschool aged children, captured using the Pediatric Sleep Questionnaire.
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Day 1, and again 3 months later.
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Change in asthma symptoms
Time Frame: baseline and 3 months
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Changes in parental report of symptoms (using the TRACK questionnaire) and clinically assessed symptoms (PRAM scale, ISAAC modified questions) over 3 month time frame.
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baseline and 3 months
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Change in Forced Oscillation Technique (FOT) values in wheezing subjects.
Time Frame: baseline and 3 months
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Determine whether a change in FOT values (lung impedence) over 3 month period distinguishes two groups of wheezing children (high vs. low risk for asthma) as determined by API.
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baseline and 3 months
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Change in spirometry values in wheezing subjects.
Time Frame: baseline and 3 months
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Determine whether a change in spirometric indices (i.e.
FEV1, FEV0.75, FVC, FEV1/FVC,PEF) over a 3 month period distinguishes two groups of wheezing children (high vs. low risk for asthma) as determined by API.
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baseline and 3 months
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Comparison of LCI values between wheezy subjects and healthy controls.
Time Frame: Day 1 for wheezing subjects and healthy controls, and again 3 months later for wheezing subjects.
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Determine if LCI values in preschool children differ between children with no history of wheeze and those with recurrent wheeze.
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Day 1 for wheezing subjects and healthy controls, and again 3 months later for wheezing subjects.
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Comparison of forced oscillation technique (FOT; lung impedence) values between wheezy subjects and healthy controls.
Time Frame: Day 1 for wheezing subjects and healthy controls, and again 3 months later for wheezing subjects.
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Determine if FOT values in preschool children differ between children with no history of wheeze and those with recurrent wheeze.
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Day 1 for wheezing subjects and healthy controls, and again 3 months later for wheezing subjects.
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Comparison of spirometric values between wheezy subjects and healthy controls.
Time Frame: Day 1 for wheezing subjects and healthy controls, and again 3 months later for wheezing subjects.
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Determine if spirometric indices (i.e.
FEV1, FEV0.75, FVC, FEV1/FVC,PEF) in preschool children differ between children with no history of wheeze and those with recurrent wheeze.
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Day 1 for wheezing subjects and healthy controls, and again 3 months later for wheezing subjects.
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Change in nasal microbiome in wheezing subjects
Time Frame: Day 1 and 3 months
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A nasal swab collected at Day 1 and again 3 months later will allow us to categorize the change in bacterial and viral communities of the nasal microbiome in wheezing subjects during and post wheezing exacerbations.
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Day 1 and 3 months
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Viral infections causing wheezing
Time Frame: Day 1
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A nasal swab collected at Day 1 will be used to determine which viruses are causing wheezing in wheezing subjects.
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Day 1
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Basophil activation test (BAT)
Time Frame: Day 1 and 3 months
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Determine the ability of the BAT to confirm food allergies in a wheezing cohort.
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Day 1 and 3 months
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Lung epithelial cell immune response in wheezing subjects.
Time Frame: Day 1 and 3 months
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Epithelial lung cells collected from the inferior turbinate in wheezing subjects will be stimulated with viruses to categorize and differentiate immune cell response in wheezing subjects.
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Day 1 and 3 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Padmaja Subbarao, MD, The Hospital For Sick Children
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Respiratory Tract Diseases
- Immune System Diseases
- Apnea
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Sleep Apnea Syndromes
- Sleep Apnea, Obstructive
- Asthma
- Food Hypersensitivity
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic Agonists
- Anti-Asthmatic Agents
- Respiratory System Agents
- Reproductive Control Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Tocolytic Agents
- Albuterol
- Bronchodilator Agents
Other Study ID Numbers
- 1000041089
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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