Methacholine Challenge Test in School Children With/Without Asthma RISKA

NCT07031102 | Recruiting

• 1 other identifier: HUS/5351/2024
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma Bronchiale; Lung Function Tests; Bronchial Hyperresponsiveness

Keywords

Asthma; Lung function test; children; Methacholine challange test; Bronchial provocation test

Outcome Measures

Primary Outcomes (2)

• 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

  Baseline

• FeNO in study groups

  To determine whether a corresponding difference exists in exhaled nitric oxide levels between the groups

  Baseline

Secondary Outcomes (3)

• Age and BHR

  Baseline

• Allergic sensitization and BHR

  Baseline

• Eosinophils and BHR

  Baseline

Study Arms (3)

Controlled Asthma

Children with asthma without need to intensify asthma treatment

Unocontrolled Asthma

Children with asthma and need to intensify their asthma treatment

Controlls

Children without asthmatic symptoms and medication

Eligibility Criteria

• Age: 7 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

• 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
• Written informed consent from the participant and guardian
• Aged 7-15 years, both sexes
• Physician-diagnosed asthma (ICD-10 codes J45.0/J45.1/J45.9)
• Inhaled corticosteroid treatment for at least 6 months
• Either:
• Well-controlled asthma (c-ACT/ACT score ≥20) and no clinical need to intensify medication, or
• Poorly controlled asthma with physician-confirmed need for intensified asthma medication

You may not qualify if:

• 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
• Active immunological disease

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

HUS Skin and Allergy Hospital

Helsinki, 00250, Finland

RECRUITING

MeSH Terms

Conditions

Bronchial Hyperreactivity; Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Mika Mäkelä, Professor, PhD, MD

  HUS

  STUDY CHAIR

Central Study Contacts

Janne Burman, PhD, MD

CONTACT

+358406517912; janne.burman@hus.fi

Anssi Koivuselkä, Nurse

CONTACT

anssi.koivuselka@hus.fi

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, MD, Pediatric Allergist

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 22, 2025
• Study Start: November 6, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 22, 2025

Record last verified: 2025-06

Locations

FI (1)