Phenotyping and Classifying Asthma Exacerbations

NCT05304039 | Active Not Recruiting

• 1 other identifier: NL79257.100.21
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma Attack

Keywords

Asthma; Exacerbation; Phenotyping; Classification; Treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Prediction model for the treatment response of acute asthma exacerbation

  42 days

• Aetiology of the acute asthma exacerbation

  42 days

• Immune system and microbiome

  42 days

Study Arms (1)

Asthma exacerbation

Patients with an asthma exacerbation who are diagnosed with mild to severe asthma according to the GINA guidelines

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

Interventions

Questionnaires BEHAVIORAL

Questionnaires about asthma control and quality of life

Asthma exacerbation

Spirometry DEVICE

Spirometry monitoring at home

Asthma exacerbation

Fractional Exhaled Nitric Oxide (FeNO) DEVICE

Measuring fractional exhaled nitric oxide at home

Asthma exacerbation

Corsano watch DEVICE

Monitoring vital parameters at home

Asthma exacerbation

e-Nose DEVICE

Breathprint will be performed using e-Nose

Asthma exacerbation

Nasopharyngeal swabs and nasal lining fluid PROCEDURE

Nasopharyngeal swabs and nasal lining fluid will be performed

Asthma exacerbation

Sputum culture DEVICE

If patients produce sputum, the sputum will be analysed

Asthma exacerbation

Blood sample PROCEDURE

Blood sample for standard care and 10 ml extra will be taken

Asthma exacerbation

Eligibility Criteria

• Age: 12 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Franciscus Gasthuis: lead
• Erasmus Medical Center: collaborator
• TNO: collaborator

Study Sites (1)

Franciscus Gasthuis & Vlietland

Rotterdam, 3045PM, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood Nasopharyngeal swabs Nasal lining fluid Sputum

MeSH Terms

Conditions

Asthma

Interventions

Surveys and Questionnaires; Spirometry; Fractional Exhaled Nitric Oxide Testing; Electronic Nose; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Breath Tests; Diagnostic Equipment; Equipment and Supplies; Electrical Equipment and Supplies; Specimen Handling; Clinical Laboratory Techniques; Punctures; Surgical Procedures, Operative

Study Officials

• Gert-Jan Braunstahl, MD, PhD

  Franciscus Gasthuis & Vlietland

  PRINCIPAL INVESTIGATOR

• Gerdien Tramper, MD, PhD

  Franciscus Gasthuis & Vlietland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: March 31, 2022
• Study Start: September 28, 2022
• Primary Completion: March 31, 2025
• Study Completion: December 1, 2025
• Last Updated: August 21, 2025

Record last verified: 2025-08

Locations

NL (1)