Classifying asthma exacerbations to improve treatment response

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

This study is testing how to better classify asthma attacks in people aged 12 to 70 to see if it can help personalize treatments and improve their response to medication.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 12 Years to 70 Years
• Sex: All
• Sponsor: Franciscus Gasthuis (Academic / other)
• Locations: 1 site (Rotterdam)
• Trial ID: NCT05304039 on ClinicalTrials.gov

What this trial studies

This observational study aims to classify and phenotype asthma exacerbations in patients aged 12 to 70 years who are experiencing an acute asthma attack. By examining the relationship between phenotypical characteristics and treatment response, the study seeks to personalize treatment approaches for asthma exacerbations. Patients will be assessed using various methods including questionnaires, spirometry, and biomarkers to develop a prediction model for treatment response. The study will take place at multiple centers, focusing on patients diagnosed with mild to severe asthma according to established guidelines.

Who should consider this trial

Good fit: Ideal candidates are patients aged 12 to 70 years with a diagnosis of mild to severe asthma who are experiencing an acute exacerbation.

Not a fit: Patients on immunosuppressive maintenance medications or those who have recently discontinued such treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for asthma exacerbations.

How similar studies have performed: Other studies have shown promise in phenotyping asthma and improving treatment responses, indicating that this approach has potential for success.

Eligibility criteria

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.

Where this trial is running

Rotterdam

• Franciscus Gasthuis & Vlietland — Rotterdam, Netherlands (Recruiting)

Study contacts

• Principal investigator: Gert-Jan Braunstahl, MD, PhD — Franciscus Gasthuis & Vlietland
• Study coordinator: Anne-Lotte Redel, MD

Conditions Asthma Attack; Asthma; Exacerbation; Phenotyping; Classification; Treatment