Status:
ACTIVE_NOT_RECRUITING
Phenotyping and Classifying Asthma Exacerbations
Lead Sponsor:
Franciscus Gasthuis
Collaborating Sponsors:
Erasmus Medical Center
TNO
Conditions:
Asthma Attack
Eligibility:
All Genders
12-70 years
Brief 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 an...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 28 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05304039
Start Date
September 28 2022
End Date
December 1 2025
Last Update
August 21 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Franciscus Gasthuis & Vlietland
Rotterdam, Netherlands, 3045PM