NCT05304039

Phenotyping and Classifying Asthma Exacerbations

Phenotyping and Classifying of Childhood and Adult Asthma Exacerbations: Towards Personalised Treatment. An Observational Multicentre Study.

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Franciscus Gasthuis · Academic / Other
• Sex: All
• Age: 12 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
BEHAVIORAL	Questionnaires	Questionnaires about asthma control and quality of life
DEVICE	Spirometry	Spirometry monitoring at home
DEVICE	Fractional Exhaled Nitric Oxide (FeNO)	Measuring fractional exhaled nitric oxide at home
DEVICE	Corsano watch	Monitoring vital parameters at home
DEVICE	e-Nose	Breathprint will be performed using e-Nose
PROCEDURE	Nasopharyngeal swabs and nasal lining fluid	Nasopharyngeal swabs and nasal lining fluid will be performed
DEVICE	Sputum culture	If patients produce sputum, the sputum will be analysed
PROCEDURE	Blood sample	Blood sample for standard care and 10 ml extra will be taken

Timeline

• Start date: 2022-09-28
• Primary completion: 2025-03-31
• Completion: 2025-12-01
• First posted: 2022-03-31
• Last updated: 2025-08-21

Locations

1 site across 1 country: Netherlands