Phenotyping and Classifying Asthma Exacerbations

Asthma Attack Clinical Trial

— ExCluSieF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05304039
• Other study ID #: NL79257.100.21
• Status: Recruiting
• Start date: September 28, 2022
• Est. completion date: May 2025

Study information

• Verified date: April 2024
• Source: Franciscus Gasthuis
• Contact: Anne-Lotte Redel, MD
• Phone: +31613320538
• Email: a.redel2[@]franciscus.nl
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Asthma
• Asthma Attack

Intervention

Behavioral:
• Questionnaires
Questionnaires about asthma control and quality of life

Device:
• Spirometry
Spirometry monitoring at home
• Fractional Exhaled Nitric Oxide (FeNO)
Measuring fractional exhaled nitric oxide at home
• Corsano watch
Monitoring vital parameters at home
• 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

Locations

Country	Name	City	State
Netherlands	Franciscus Gasthuis & Vlietland	Rotterdam

Sponsors (3)

Lead Sponsor	Collaborator
Franciscus Gasthuis	Erasmus Medical Center, TNO

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%).	7 days
Secondary	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	42 days
Secondary	Aetiology of the acute asthma exacerbation	Analysing the aetiology of the acute asthma exacerbations	42 days
Secondary	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	42 days