Asthma BronchialeRISKANCT07031102
Methacholine Challenge Test in School Children With/Without Asthma RISKA
An observational study of Asthma Bronchiale and Lung Function Tests, run by Helsinki University Central Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma Bronchiale, Lung Function Tests, Bronchial Hyperresponsiveness
- How many people
- 260 participants
- Where
- 1 siteFinland
- Study dates
- 6 Nov 2024to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
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
Who may be able to join
- • 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
Show all 11Show fewer
- 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
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Anssi Koivuselkä, Nurse contact
Finland1 site, 1 recruiting
- Recruiting
HUS Skin and Allergy Hospital
Helsinki, 00250
Janne Burman, PhD, MD, +358406517912, janne.burman@hus.fi
About this study
Official title: RISKA: Respiratory Irritability With School Kids With/Without Asthma - Assessment of Methacholine Responsiveness in Pediatric Asthma: A Comparative Study With Healthy Controls
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.
Read the detailed description
Study type: Observational study Study sites: Skin and Allergy Hospital, Helsinki, Finland Inclusion criteria: Age 7-15 years, diagnosed with asthma and on regular asthma medication with physician-assessed good asthma control (55 participants), suboptimal asthma control (55 participants), or healthy controls with no inhaled asthma medication or asthma-related symptoms in the preceding two years (150 participants).
Exclusion criteria: Other respiratory, cardiovascular, or neurological diseases; acute respiratory infection within 2 weeks; respiratory disorders related to prematurity; implanted or external active medical devices.
Sample size: 110 asthma patients and 150 healthy controls. Study duration: Until the end of 2027 Study visits: One study visit; in addition, consent will be sought to contact participants during the 15-year storage period of the study data, for example, regarding questionnaire follow-ups.
Objectives:
Primary:
To determine whether airway hyperresponsiveness differs clinically significantly (PD20FEV1 at least twofold difference) between children with well-controlled asthma, those requiring intensified asthma medication, and healthy controls.
To determine whether a corresponding difference exists in exhaled nitric oxide levels between the groups.
Secondary:
To assess how age correlates with airway hyperresponsiveness (PD20FEV1 value) in the methacholine challenge among healthy controls.
To assess how sensitization to airborne allergens correlates with PD20FEV1 values in healthy controls and asthma patients.
To assess how blood eosinophil levels correlate with PD20FEV1 values in the methacholine challenge in both healthy controls and asthma patients.
Implementation:
Healthy controls will undergo a pre-study telephone interview to assess eligibility. At the study visit, background information and asthma questionnaires will be completed. The study visit will include a methacholine challenge test measuring airway hyperresponsiveness and an exhaled nitric oxide measurement. The effect of medication intensification in asthma patients will be evaluated via a telephone interview 1-2 months after the medication adjustment.
- Keywords
- Asthma, Lung function test, children, Methacholine challange test, Bronchial provocation test
- Medical subject headings
- Bronchial Hyperreactivity, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
FeNO in study groups
To determine whether a corresponding difference exists in exhaled nitric oxide levels between the groups
Measured: Baseline
Secondary outcomes (3)
Age and BHR
assess how age correlates with airway hyperresponsiveness (PD20FEV1 value) in the methacholine challenge among healthy controls
Measured: Baseline
Allergic sensitization and BHR
assess how sensitization to airborne allergens correlates with PD20FEV1 values in healthy controls and asthma patients
Measured: Baseline
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start6 Nov 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma BronchialeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janne Burman, Helsinki University Central Hospital
- Investigators
- Mika Mäkelä, Professor, PhD, MD, Study chair, HUS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07031102
- Sponsor's protocol ID
- HUS/5351/2024
- Acronym
- RISKA
- Status last verified
- Jun 2025
- First submitted
- 30 May 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RISKA: Respiratory Irritability With School Kids With/Without Asthma - Assessment of Methacholine Responsiveness in Pediatric Asthma: A Comparative Study With Healthy Controls
- ClinicalTrials.gov ID
- NCT07031102
- Acronym / sponsor ID
- RISKA / HUS/5351/2024
- Keywords
- Asthma, Lung function test, children, Methacholine challange test, Bronchial provocation test
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 6 Nov 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 22 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study type: Observational study Study sites: Skin and Allergy Hospital, Helsinki, Finland Inclusion criteria: Age 7-15 years, diagnosed with asthma and on regular asthma medication with physician-assessed good asthma control (55 participants), suboptimal asthma control (55 participants), or healthy controls with no inhaled asthma medication or asthma-related symptoms in the preceding two years (150 participants).
Exclusion criteria: Other respiratory, cardiovascular, or neurological diseases; acute respiratory infection within 2 weeks; respiratory disorders related to prematurity; implanted or external active medical devices.
Sample size: 110 asthma patients and 150 healthy controls. Study duration: Until the end of 2027 Study visits: One study visit; in addition, consent will be sought to contact participants during the 15-year storage period of the study data, for example, regarding questionnaire follow-ups.
Objectives:
Primary:
To determine whether airway hyperresponsiveness differs clinically significantly (PD20FEV1 at least twofold difference) between children with well-controlled asthma, those requiring intensified asthma medication, and healthy controls.
To determine whether a corresponding difference exists in exhaled nitric oxide levels between the groups.
Secondary:
To assess how age correlates with airway hyperresponsiveness (PD20FEV1 value) in the methacholine challenge among healthy controls.
To assess how sensitization to airborne allergens correlates with PD20FEV1 values in healthy controls and asthma patients.
To assess how blood eosinophil levels correlate with PD20FEV1 values in the methacholine challenge in both healthy controls and asthma patients.
Implementation:
Healthy controls will undergo a pre-study telephone interview to assess eligibility. At the study visit, background information and asthma questionnaires will be completed. The study visit will include a methacholine challenge test measuring airway hyperresponsiveness and an exhaled nitric oxide measurement. The effect of medication intensification in asthma patients will be evaluated via a telephone interview 1-2 months after the medication adjustment.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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
Key inclusion criteria (11 listed)
- • Aged 7-15 years, both sexes
- 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:
Key exclusion criteria (5 listed)
- • Premature birth before 32 gestational weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
BHR and asthma balance
Time frame: Baseline
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
FeNO in study groups
Time frame: Baseline
To determine whether a corresponding difference exists in exhaled nitric oxide levels between the groups
3 secondary outcomes
Age and BHR
Time frame: Baseline
Allergic sensitization and BHR
Time frame: Baseline
Eosinophils and BHR
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anssi Koivuselkä, Nurse contact
Mika Mäkelä, Professor, PhD, MD study chair
HUS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma Bronchiale and Lung Function Tests, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Janne Burman, PhD, MD (+358406517912, janne.burman@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BHR and asthma balance (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025.