Methacholine challenge to measure airway sensitivity in school-aged children with and without asthma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will enroll about 110 children with physician-diagnosed asthma (split between well-controlled and those needing intensified medication) and 150 healthy controls aged 7–15. At a single study visit participants complete background and asthma questionnaires, undergo a methacholine bronchial provocation test to measure PD20FEV1, and have exhaled nitric oxide measured. Healthy controls are pre-screened by telephone and asthma patients who have medication changes are contacted again by phone 1–2 months later to capture effects of intensification. Key exclusions include recent respiratory infection, other chronic cardiopulmonary or neurological disease, prematurity before 32 weeks, active immunologic disease, and beta-blocker use.

Why it matters

Who can join: the full rules

Inclusion Criteria: Healthy Controls

* • 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

Inclusion Criteria: Children with Asthma

* 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

Exclusion Criteria:

* • 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

Where it's running

• HUS Skin and Allergy Hospital
  Helsinki, Finland Recruiting

Study contacts

• Study coordinator: Janne Burman, PhD, MD
• Email: janne.burman@hus.fi
• Phone: +358406517912

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.