J45
Conditions
Interventions
Group 1: At least 6 patients with an asthma exacerbation
First visit:
We collect information about you (e.g. age, weight, medications)
We measure your vital signs (blood pressure, pulse, etc.)
There is a physical examination and lung function tests
Saliva samples are taken
Blood samples are taken in the amount required for routine laboratory testing.
Saliva samples at home:
In the event of acute asthma attacks: daily for the first 7 days
After that: weekly for 5 weeks for all participants
You will also complete short questionnaires.
Interim check-up (day 42):
We repeat the examinations and saliva samples
We check whether you have had any side effects or new asthma attacks
Treatment can be adjusted if necessary.
Final visit (day 84):
Final examinations, questionnaires and samples
Check for side effects and asthma attacks
After that, your doctor will take over your further care.
Group 2: 30 patients with stable asthma, i.e. no asthma exacerbation within 4 weeks of enrolment in the study
Sponsors
Universitätsklinikum Freiburg - Klinik für Pneumologie
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Clinically confirmed diagnosis of asthma, as per the Global Initiative for Asthma (GINA), 2025 guidelines. 2. Adults aged 18-85 years 3. Ability to provide written informed consent to participate the in the study. 4. Willing to adhere to study protocols, including regular at-home saliva biomarker sampling and the completion of Patient-Reported Outcomes (PRO).
Exclusion criteria
Exclusion criteria: 1. Diagnosis of chronic obstructive pulmonary disease (COPD), bronchiectasis, or other chronic respiratory diseases other than asthma. 2. Significant comorbid conditions that could interfere with asthma management or the biomarker analysis (e.g., uncontrolled diabetes, kidney disease, etc.). 3. Immunosuppressive conditions, including HIV, organ transplantation, and ongoing chemotherapy. 4. Chronic use of oral steroids with a dosage = 20mg per day 5. Pregnancy or breastfeeding. 6. Involvement in other clinical trials or treatments that could interfere with the study outcomes or biomarker measurements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Variability of saliva IL-33 (and additional inflammatory-associated biomarkers, if funding is available) at multiple time points, and their association with asthma exacerbation. Association between saliva IL-33 (other inflammation-associated biomarkers, where measurement is funded) levels and clinical asthma control indicators, including Asthma Control Test (ACT), Asthma Control Questionnaire (ACQ) - 5, Asthma Quality of Life Questionnaire (AQLQ)-mini scores, pulmonary function parameters (FEV1, Diffusion capacity of the lung for carbon monoxide (DLCO), Range of respiratory resistance measurements at 5-20 Hz (R5–R20), Airway Reactance (AX)) and FeNO. Changes in asthma control indicators (ACT, ACQ-5, AQLQ-mini scores, FEV1, DLCO, R5–R20, AX and FeNO) following adjustments in asthma treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of the functionality and accuracy of home-based saliva collection for biomarker quantification, determined by the percentage of successful sample collection attempts, and assessment of patient acceptance measured using the Visual Analog Scale (VAS). | — |
Countries
Germany
Contacts
Public ContactDaiana Stolz
Universitätsklinikum Freiburg - Klinik für Penumologie
Outcome results
None listed