Actively Recruiting

Age: 7Years - 15Years
All Genders
Healthy Volunteers
ID07031102

RISKA: Assessment of Methacholine Responsiveness in School Children With and Without Asthma - A Comparative Observational Study

Led by Helsinki University Central Hospital · Updated on 2025-06-22

260

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to compare airway responsiveness and lung function in school children aged 7 to 15 years with and without asthma. It includes children with well-controlled asthma, those who need increased asthma medication, and healthy controls with no recent asthma symptoms or medication. The study evaluates differences in airway hyperresponsiveness and exhaled nitric oxide levels among these groups, also examining how age, allergen sensitization, and blood eosinophil levels relate to airway responsiveness. Participants include children diagnosed with asthma who are on inhaled corticosteroids, divided into groups based on asthma control and medication needs, and healthy controls without asthma diagnosis or recent symptoms. Healthy controls undergo a telephone interview before the study visit to confirm eligibility. During the visit, participants complete background and asthma questionnaires, a methacholine challenge test to measure airway hyperresponsiveness, and an exhaled nitric oxide test. For asthma patients requiring medication adjustment, a follow-up telephone interview is conducted 1 to 2 months after medication changes. Participants will be assessed during a single study visit where lung function tests and questionnaires are completed. Researchers will measure airway hyperresponsiveness using the methacholine challenge and exhaled nitric oxide levels. Data regarding age, allergen sensitization, and blood eosinophils will also be collected. Consent will be sought to allow future contact during a 15-year storage period of study data for follow-up questionnaires. The study is expected to continue until the end of 2027.

CONDITIONS

Brief Title

Methacholine Challenge Test in School Children With/Without Asthma RISKA

Who Can Participate

Age: 7Years - 15Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 7 to 15 years, both sexes
  • Healthy controls with no asthma diagnosis in childhood
  • No inhaled asthma medication or asthma symptoms in the past 2 years for healthy controls
  • Children with physician-diagnosed asthma (ICD-10 J45.0/J45.1/J45.9)
  • Inhaled corticosteroid treatment for at least 6 months for asthma patients
  • Asthma patients with either well-controlled asthma (c-ACT/ACT score 60) and no need to intensify medication, or poorly controlled asthma requiring intensified medication
  • Written informed consent from participant and guardian
Not Eligible

You will not qualify if you...

  • Premature birth before 32 gestational weeks
  • Other chronic cardiopulmonary or neurological diseases affecting airways (excluding asthma)
  • Severe underlying illness such as malignancy
  • Use of beta-blocker medication
  • Active immunological disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants complete questionnaires and undergo a methacholine challenge test and exhaled nitric oxide measurement to assess airway responsiveness and inflammation.

1 study visit (in-person)

Long-term Monitoring

Duration - Up to 15 years

Participants may be contacted for follow-up questionnaires during the 15-year storage period of the study data to assess long-term outcomes.

Follow-up contacts by telephone or mail as needed

Trial Site Locations

Total: 1 location

1

HUS Skin and Allergy Hospital

Helsinki, Finland, 00250

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Research Team

J

Janne Burman, PhD, MD

A

Anssi Koivuselkä, Nurse

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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