Asthma Exacerbation Astma Exacerbatie
Conditions
Interventions
Cessation of inhaled steroids during 8 weeks.
Sponsors
Academic Medical Centre, University of Amsterdam.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age >18 years; 2. Mild to moderately severe persistent asthma according to the criteria GINA [2]: A. Recurrent wheezing and/or chest tightness and/or shortness of breath AND; B. Airway hyperresponsiveness, indicated by a positive methacholine or histamine challenge with PC20 2 days leading to ER or GP visit because of asthma, not requiring systemic corticosteroids, but an increase/change in medication to prevent the exacerbation from becoming severe. 8. Non-smoking or stopped smoking more than 12 months ago and a total maximum of 5 pack years; 9. No other clinically significant abnormality on history and clinical examination; 10. Able to give written and dated informed consent prior to any study-specific procedures.
Exclusion criteria
Exclusion criteria: 1. Change in the dose of ICS within 4 weeks prior to screening; 2. A course of oral corticosteroids, antibiotics or a respiratory infection within 4 weeks prior to the study; 3. Use of ipratropium, anti-IgE or oral corticosteroids; 4. Pregnancy; 5. Concomitant disease or condition which could interfere with the conduct of the study, or which treatment might interfere with the conduct of the study, or which would, in the opinion of the investigator, pose an unacceptable risk to the patient in this study; 6. Unwillingness or inability to comply with the study protocol for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Breathprints of volatile organic compounds which are associated with loss of asthma control (deterioration in symptoms and lung function) after interruption of inhaled steroid therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The critical VOCs of these breathprints in exhaled air by gas chromatography and mass spectrometry (GC-MS); 2. The individual biomarkers in sputum, blood and EBC that are associated with asthma control and electronic nose and GC-MS breathprints; 3. The effect of loss of asthma control by interruption of inhaled steroids on haemostatic activity; 4. The association between markers of coagulation, inflammation and exhaled molecular profiles assessed by electronic nose and GC-MS. | — |
Contacts
Public ContactNiki Fens
Academic Medical Centre, University of Amsterdam Dept. Respiratory Medicine, F5-260 Meibergdreef 9
Outcome results
None listed