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

RISKA: Respiratory Irritability With School Kids With/Without Asthma - Assessment of Methacholine Responsiveness in Pediatric Asthma: A Comparative Study With Healthy Controls

We will test whether a methacholine breathing test and exhaled nitric oxide levels differ between children aged 7–15 who have well-controlled asthma, need stronger asthma treatment, or have no asthma.

Quick facts

• Study type: Observational
• Enrollment: 260 (estimated)
• Ages: 7 Years to 15 Years
• Sex: All
• Sponsor: Helsinki University Central Hospital (Academic / other)
• Locations: 1 site (Helsinki)
• Trial ID: NCT07031102 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Children aged 7–15 with either physician-diagnosed asthma on inhaled corticosteroids (with either well-controlled disease or a physician-confirmed need to intensify medication) or healthy children with no asthma symptoms or inhaled asthma medication in the prior two years, able to attend the Helsinki site and provide guardian consent.

Not a fit: Children with other chronic cardiopulmonary or neurological diseases, recent acute respiratory infection, prematurity before 32 weeks, active immunologic disease, use of beta-blockers, or implanted active medical devices are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the findings could help clinicians better identify which children have clinically important airway hyperresponsiveness and tailor asthma treatment accordingly.

How similar studies have performed: Methacholine bronchial challenge and exhaled nitric oxide are established tests for airway hyperresponsiveness and inflammation, and prior research supports their use in pediatric and adult populations though pediatric comparison data are more limited.

Eligibility criteria

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 this trial is running

Helsinki

• HUS Skin and Allergy Hospital — Helsinki, Finland (Recruiting)

Study contacts

• Study coordinator: Janne Burman, PhD, MD

Conditions Asthma Bronchiale; Lung Function Tests; Bronchial Hyperresponsiveness; Asthma; Lung function test; children; Methacholine challange test; Bronchial provocation test