Asthma AttackExCluSieFNCT05304039
Phenotyping and Classifying Asthma Exacerbations
An observational study of Asthma Attack, run by Franciscus Gasthuis at 1 site in Netherlands.
Trial summary
An observational study in patients between 12 and 70 years old with an acute asthma exacerbation, to determine the relation between phenotypical characteristics and the treatment response. Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Asthma Attack
- What is being tested?
- Questionnaires, Spirometry and Fractional Exhaled Nitric Oxide (FeNO)
- Type of treatment
- Medical device, Surgery or procedure, Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteNetherlands
- Study dates
- 28 Sep 2022to Dec 2025
- 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 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients aged 12 - 70 years, diagnosed with mild to severe asthma according to the Global Initiative for Asthma (GINA) guidelines. Patients will be included at the onset of a (severe) asthma exacerbation.
Who may be able to join
- Patient diagnosed with asthma according to the GINA guidelines between 12 and 70 years old. If patients are doctor's diagnosed with asthma based on clinical data, the further diagnostics will be performed to confirm the asthma diagnosis after the AAE.
- Mild to severe asthma, treated according to GINA guidelines with medium - or high dose inhaled corticosteroids (with or without LABA) or treated with a low dose inhaled corticosteroids combined LABA or leukotriene - receptor antagonist.
- Asthma exacerbation, indicated for systemic corticosteroids.
- Written personal and/or parental informed consent, prior to any study procedures.
- Eligibility and willingness to present during an asthma exacerbation at the Franciscus Gasthuis hospital.
- Ability to use e - health applications.
Who cannot join
- Immunosuppressive maintenance medication (azithromycin, systemic corticosteroids maintenance therapy and other) or recently (< 6 weeks) discontinued these medications. (Desensitization therapy indicated for allergies can be included in the study)
- Maintenance medication or recently discontinued (< 6 weeks) biologicals.
- Other underlying inflammatory or auto-immune diseases, such as rheumatologic disease.
- Involvement in the planning and/or conduct of the study (applies to both investigator staff and/or staff at the study site)
- Pregnancy, because of the possible altered immunological status.(31)
- Participation in an interventional study or randomised controlled trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phenotyping and Classifying of Childhood and Adult Asthma Exacerbations: Towards Personalised Treatment. An Observational Multicentre Study.
An observational study in patients between 12 and 70 years old with an acute asthma exacerbation, to determine the relation between phenotypical characteristics and the treatment response.
Read the detailed description
Rationale: Asthma is a heterogeneous inflammatory respiratory disease affecting 8 - 9% of the European population. Acute asthma exacerbation (AAE) is characterized as an acute worsening of symptoms and is treated inconsistently with steroids with or without antibiotics. In order to adjust and personalise exacerbation treatment, phenotyping and classifying of asthma exacerbations would be required. Therefore, we want to classify patients with AAEs phenotypically in relation to the treatment response.
Objective: The primary objective of the study is to determine the relationship between exacerbation treatment response at day 7 and the phenotypical characteristics of asthma exacerbations. Secondary objectives are 1) developing a prediction model based on biomarkers and/or clinical data to predict the treatment response of AAEs 2) comparing the environmental, inflammatory, microbiological and lipid parameters of patients diagnosed with asthma between exacerbation phase and recovery (baseline).
Study design: A prospective cohort multicentre study. Study population: Patients aged 12 - 70 years, diagnosed with mild to severe asthma according to the Global Initiative for Asthma (GINA) guidelines. Patients will be included at the onset of a severe asthma exacerbation.
Main study parameters/endpoints: Primary endpoint is the relation of phenotypical characteristics with treatment response at day 7, defined by 1) the physician - and patient rated global evaluation of treatment effectiveness (GETE) score 2) difference in Asthma Control Questionnaire 5 (ACQ-5) (> 0.5) 3) difference in handheld spirometry values like forced expiratory volume (FEV1 ≥ 10%). Treatment response will be classified as excellent, good, moderate or poor. Secondary endpoints are 1) a prediction model for the treatment response of AAE 2) aetiology of the AAE 3) blood and local respiratory parameters; microbiota composition; lipid metabolomics and volatile compounds composition at baseline and AAE.
- Conditions
- Asthma Attack
- Being tested
- Questionnaires, Spirometry, Fractional Exhaled Nitric Oxide (FeNO), Corsano watch, e-Nose
- Keywords
- Asthma, Exacerbation, Phenotyping, Classification, Treatment
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesBehavioural
Questionnaires about asthma control and quality of life
SpirometryDevice
Spirometry monitoring at home
Fractional Exhaled Nitric Oxide (FeNO)Device
Measuring fractional exhaled nitric oxide at home
Corsano watchDevice
Monitoring vital parameters at home
e-NoseDevice
Breathprint will be performed using e-Nose
Nasopharyngeal swabs and nasal lining fluidProcedure or surgery
Nasopharyngeal swabs and nasal lining fluid will be performed
Sputum cultureDevice
If patients produce sputum, the sputum will be analysed
Blood sampleProcedure or surgery
Blood sample for standard care and 10 ml extra will be taken
| Study group | Role | What they receive |
|---|---|---|
| Asthma exacerbation | Patients with an asthma exacerbation who are diagnosed with mild to severe asthma according to the GINA guidelines Receives: Behavioral: Questionnaires; Device: Spirometry; Device: Fractional Exhaled Nitric Oxide (FeNO); Device: Corsano watch; Device: e-Nose; Procedure: Nasopharyngeal swabs and nasal lining fluid; Device: Sputum culture; Procedure: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relation of phenotypical characteristics with treatment response
Relation of phenotyipcal characteristics with treatment response defined by 1) the physician - and patient rated global evaluation of treatment effectiveness (GETE) score 2) difference in Asthma Control Questionnaire 5 (ACQ-5) (> 0.5) 3) difference in handheld spirometry values like forced expiratory volume (FEV1 ≥ 10%).
Measured: 7 days
Secondary outcomes (3)
Prediction model for the treatment response of acute asthma exacerbation
Creating a prediction model for the treatment response of acute asthma exacerbation with phenotypical characteristics
Measured: 42 days
Aetiology of the acute asthma exacerbation
Analysing the aetiology of the acute asthma exacerbations
Measured: 42 days
Immune system and microbiome
Analysing the blood and local respiratory parameters; the microbiota composition; lipid metabolomics and volatile compounds composition at baseline and acute asthma exacerbation
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start28 Sep 2022
- Primary completion31 Mar 2025
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma AttackStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Franciscus Gasthuis
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center, TNO
- Responsible party
- Sponsor
- Investigators
- Gert-Jan Braunstahl, MD, PhD, Principal investigator, Franciscus Gasthuis & VlietlandGerdien Tramper, MD, PhD, Principal investigator, Franciscus Gasthuis & Vlietland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05304039
- Sponsor's protocol ID
- NL79257.100.21
- Acronym
- ExCluSieF
- Status last verified
- Aug 2025
- First submitted
- 22 Mar 2022
- Last updated
- 21 Aug 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 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotyping and Classifying of Childhood and Adult Asthma Exacerbations: Towards Personalised Treatment. An Observational Multicentre Study.
- ClinicalTrials.gov ID
- NCT05304039
- Acronym / sponsor ID
- ExCluSieF / NL79257.100.21
- Conditions
- Asthma Attack
- Keywords
- Asthma, Exacerbation, Phenotyping, Classification, Treatment
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Franciscus GasthuisUniversity, hospital or other
- Collaborators
- Erasmus Medical Center, TNO
- Study start
- 28 Sep 2022 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 31 Mar 2022 (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.
An observational study in patients between 12 and 70 years old with an acute asthma exacerbation, to determine the relation between phenotypical characteristics and the treatment response.
Detailed description
Rationale: Asthma is a heterogeneous inflammatory respiratory disease affecting 8 - 9% of the European population. Acute asthma exacerbation (AAE) is characterized as an acute worsening of symptoms and is treated inconsistently with steroids with or without antibiotics. In order to adjust and personalise exacerbation treatment, phenotyping and classifying of asthma exacerbations would be required. Therefore, we want to classify patients with AAEs phenotypically in relation to the treatment response.
Objective: The primary objective of the study is to determine the relationship between exacerbation treatment response at day 7 and the phenotypical characteristics of asthma exacerbations. Secondary objectives are 1) developing a prediction model based on biomarkers and/or clinical data to predict the treatment response of AAEs 2) comparing the environmental, inflammatory, microbiological and lipid parameters of patients diagnosed with asthma between exacerbation phase and recovery (baseline).
Study design: A prospective cohort multicentre study. Study population: Patients aged 12 - 70 years, diagnosed with mild to severe asthma according to the Global Initiative for Asthma (GINA) guidelines. Patients will be included at the onset of a severe asthma exacerbation.
Main study parameters/endpoints: Primary endpoint is the relation of phenotypical characteristics with treatment response at day 7, defined by 1) the physician - and patient rated global evaluation of treatment effectiveness (GETE) score 2) difference in Asthma Control Questionnaire 5 (ACQ-5) (> 0.5) 3) difference in handheld spirometry values like forced expiratory volume (FEV1 ≥ 10%). Treatment response will be classified as excellent, good, moderate or poor. Secondary endpoints are 1) a prediction model for the treatment response of AAE 2) aetiology of the AAE 3) blood and local respiratory parameters; microbiota composition; lipid metabolomics and volatile compounds composition at baseline and AAE.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asthma exacerbation | – | Behavioral: Questionnaires, Device: Spirometry, Device: Fractional Exhaled Nitric Oxide (FeNO), Device: Corsano watch, Device: e-Nose, Procedure: Nasopharyngeal swabs and nasal lining fluid, Device: Sputum culture, Procedure: Blood samplePatients with an asthma exacerbation who are diagnosed with mild to severe asthma according to the GINA guidelines |
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients aged 12 - 70 years, diagnosed with mild to severe asthma according to the Global Initiative for Asthma (GINA) guidelines. Patients will be included at the onset of a (severe) asthma exacerbation.
Key inclusion criteria (6 listed)
- Patient diagnosed with asthma according to the GINA guidelines between 12 and 70 years old. If patients are doctor's diagnosed with asthma based on clinical data, the further diagnostics will be performed to confirm the asthma diagnosis after the AAE.
- Mild to severe asthma, treated according to GINA guidelines with medium - or high dose inhaled corticosteroids (with or without LABA) or treated with a low dose inhaled corticosteroids combined LABA or leukotriene - receptor antagonist.
- Asthma exacerbation, indicated for systemic corticosteroids.
- Written personal and/or parental informed consent, prior to any study procedures.
- Eligibility and willingness to present during an asthma exacerbation at the Franciscus Gasthuis hospital.
Key exclusion criteria (6 listed)
- Immunosuppressive maintenance medication (azithromycin, systemic corticosteroids maintenance therapy and other) or recently (< 6 weeks) discontinued these medications. (Desensitization therapy indicated for allergies can be included in the study)
- Maintenance medication or recently discontinued (< 6 weeks) biologicals.
- Other underlying inflammatory or auto-immune diseases, such as rheumatologic disease.
- Involvement in the planning and/or conduct of the study (applies to both investigator staff and/or staff at the study site)
- Pregnancy, because of the possible altered immunological status.(31)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesQuestionnaires about asthma control and quality of life | Behavioural | Asthma exacerbation |
| SpirometrySpirometry monitoring at home | Device | Asthma exacerbation |
| Fractional Exhaled Nitric Oxide (FeNO)Measuring fractional exhaled nitric oxide at home | Device | Asthma exacerbation |
| Corsano watchMonitoring vital parameters at home | Device | Asthma exacerbation |
| e-NoseBreathprint will be performed using e-Nose | Device | Asthma exacerbation |
| Nasopharyngeal swabs and nasal lining fluidNasopharyngeal swabs and nasal lining fluid will be performed | Procedure or surgery | Asthma exacerbation |
| Sputum cultureIf patients produce sputum, the sputum will be analysed | Device | Asthma exacerbation |
| Blood sampleBlood sample for standard care and 10 ml extra will be taken | Procedure or surgery | Asthma exacerbation |
Primary outcome
Relation of phenotypical characteristics with treatment response
Time frame: 7 days
Relation of phenotyipcal characteristics with treatment response defined by 1) the physician - and patient rated global evaluation of treatment effectiveness (GETE) score 2) difference in Asthma Control Questionnaire 5 (ACQ-5) (> 0.5) 3) difference in handheld spirometry values like forced expiratory volume (FEV1 ≥ 10%).
3 secondary outcomes
Prediction model for the treatment response of acute asthma exacerbation
Time frame: 42 days
Aetiology of the acute asthma exacerbation
Time frame: 42 days
Immune system and microbiome
Time frame: 42 days
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 21 Aug 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. This study is not recruiting at the moment.
Gert-Jan Braunstahl, MD, PhD principal investigator
Franciscus Gasthuis & Vlietland
Gerdien Tramper, MD, PhD principal investigator
Franciscus Gasthuis & Vlietland
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 Attack, run by Franciscus Gasthuis at 1 site in Netherlands.
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 6 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 21 Aug 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 Netherlands. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relation of phenotypical characteristics with treatment response (time frame: 7 days). 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 21 Aug 2025.