Methacholine Challenge Test in School Children With/Without Asthma RISKA
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age7-15
SponsorHelsinki University Central Hospital
About this trial
The study includes a pre-study telephone interview with healthy controls to assess their eligibility for participation. During the study visit, a background information form and an asthma questionnaire are completed. At the study visit, a methacholine challenge test measuring airway hyperresponsiveness and an exhaled nitric oxide measurement are performed. The effect of medication intensification in asthma patients is further assessed through a telephone interview 1-2 months after the medication adjustment.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
• Aged 7-15 years, both sexes
No diagnosis of asthma in childhood
No inhaled asthma medication during the previous 2 years
No wheezing or shortness of breath during the previous 2 years
Disqualifiers
• Premature birth before 32 gestational weeks
Other chronic cardiopulmonary or neurological conditions affecting airways (excluding asthma)
Severe underlying illness such as malignancy
Beta-blocker medication
Trial population
Participants: * 55 children with well-controlled asthma * 55 children with asthma symptoms despite regular asthma medication * 150 healthy controls without asthma symptoms in the past two years Recruitment: * Symptomatic asthma patients will be recruited from the Pediatric Allergy Unit at the Skin and Allergy Hospital, Helsinki, Finland. * Healthy controls will be recruited through sports clubs and schools in the Uusimaa Region, Finland
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
260 Participants
are grouped into 3 trial groupsGroup A: Controlled Asthma
Group B: Unocontrolled Asthma
Group C: Controlls
Trial outcomes
Primary outcomes
1
BHR and asthma balance
To determine whether airway hyperresponsiveness (defined as cumulative dose of methacholine causing 20% fall of FEV1 (PD20FEV1)) differs clinically significantly (PD20FEV1 at least twofold difference) between children with well-controlled asthma, those requiring intensified asthma medication, and healthy controls
Time frame
Baseline2
FeNO in study groups
To determine whether a corresponding difference exists in exhaled nitric oxide levels between the groups
Time frame
BaselineSecondary outcomes
1
Age and BHR
assess how age correlates with airway hyperresponsiveness (PD20FEV1 value) in the methacholine challenge among healthy controls
Time frame
Baseline2
Allergic sensitization and BHR
assess how sensitization to airborne allergens correlates with PD20FEV1 values in healthy controls and asthma patients
Time frame
Baseline3
Eosinophils and BHR
assess how blood eosinophil levels (absolute count) correlate with PD20FEV1 values in the methacholine challenge in both healthy controls and asthma patients
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov