Clinical trial NCT02743663: The Development of Novel Clinical Tests to Diagnose and Monitor Asthma in Preschool Children
Official title: The Development of Novel Clinical Tests to Diagnose and Monitor Asthma in Preschool Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Wheeze
Obstructive Sleep Apnea
Food Allergy
Virus
Keywords: pediatric
lung ventilation inhomogeneity
preschool
asthma
wheeze
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Dalhousie University
First posted: 2016-04-19
Enrollment: 121
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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)

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.

Detailed description: In Canada, the most common chronic disease of childhood is asthma. Childhood asthma places a significant burden on the health care system (refn). No objective preschool asthma diagnostic tools exist, and the current gold-standard, the Asthma Predictive Index, does not provide information about lung function and symptom management. In this study, it is hypothesized that the lung clearance index (LCI), a value derived from the multiple breath washout test, will be the most sensitive, responsive discriminative test for preschool asthma. If it proves useful in the monitoring and diagnosis of preschool asthma, LCI has the potential to improve the clinical management and thus potentially significantly reduce hospitalization rates for preschool children suffering with asthma. In this unique data set, the investigators will also compare the relative utility of the forced oscillation technique (FOT) and preschool spirometry with the LCI in order to detect abnormalities amongst those children at high risk for preschool asthma. In addition, the impact of sleep apnea as a risk factor for and modifier of asthma will be investigated in this study. Furthermore, changes to the composition of the nasal microbiome during and after a wheezing episodes and the role of viral infections in wheezing exacerbations will be explored. Finally, the utility of new methods of diagnosing food allergy, such as the basophil activation test, will be examined in this Canadian cohort.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Lung Clearance Index (LCI) in wheezing subjects.
timeFrame: baseline and 3 months
Secondary outcomes:
measure: Obstructive Sleep Apnea (OSA)
timeFrame: Day 1, and again 3 months later.
measure: Change in asthma symptoms
timeFrame: baseline and 3 months
measure: Change in Forced Oscillation Technique (FOT) values in wheezing subjects.
timeFrame: baseline and 3 months
measure: Change in spirometry values in wheezing subjects.
timeFrame: baseline and 3 months
measure: Comparison of LCI values between wheezy subjects and healthy controls.
timeFrame: Day 1 for wheezing subjects and healthy controls, and again 3 months later for wheezing subjects.
measure: Comparison of forced oscillation technique (FOT; lung impedence) values between wheezy subjects and healthy controls.
timeFrame: Day 1 for wheezing subjects and healthy controls, and again 3 months later for wheezing subjects.
measure: Comparison of spirometric values between wheezy subjects and healthy controls.
timeFrame: Day 1 for wheezing subjects and healthy controls, and again 3 months later for wheezing subjects.
measure: Change in nasal microbiome in wheezing subjects
timeFrame: Day 1 and 3 months
measure: Viral infections causing wheezing
timeFrame: Day 1
measure: Basophil activation test (BAT)
timeFrame: Day 1 and 3 months
measure: Lung epithelial cell immune response in wheezing subjects.
timeFrame: Day 1 and 3 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Padmaja Subbarao, MD
role: PRINCIPAL_INVESTIGATOR
References: