asthma chronic inflammation of the airways
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: * Age >18 years * Clinical presentation of asthma * Airway hyperresponsiveness, indicated by a positive methacholine challenge with PC20 * 8 mg/ml OR * reversibility in FEV1 of * 12% predicted * Requiring inhaled corticosteroids at high doses (* 500 ug ICS fluticasone or equivalent) * Non-smoking or stopped smoking more than 12 months ago and 10 pack years or less * No condition or treatment which may increase the risk of bleeding * No other clinically significant abnormality on history and clinical examination * Able to give written and dated informed consent prior to any study-specific procedures - sputum eosinophils > 3% * eosinophilic asthma - sputum eosinophils
Exclusion criteria
Exclusion criteria: * Change in the dose of ICS in 4 weeks prior to screening * A course of oral corticosteroids, antibiotics or a respiratory infection within 4 weeks prior to the study * Use of anti-leukotrienes, chromoglycates, anti-cholinergics within 4 weeks prior to the study * Pregnancy * 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 * Unwillingness or inability to comply with the study protocol for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| eNose breathprints of eosinophilic and non-eosinophilic asthmatic subjects. | — |
Secondary
| Measure | Time frame |
|---|---|
| * Specific molecular components that are associated with eosinophilic and non-eosinophilic asthma as determined by gas-chromatography and mass-spectrometry * Individual biomarkers and proteomic profiles in sputum, blood, urine, nasal lavage and nasal biopsies predictive for eosinophilic and non-eosinophilic asthma | — |
Countries
Netherlands