No registrations found.
ID
Source
Brief title
Health condition
Asthma; Eosinophilic asthma; Asthma subtypes; biomarker
Sponsors and support
Intervention
Outcome measures
Primary outcome
eNose breathprint of eosinophilic and non-eosinophilic astma.
Secondary outcome
Individual biomarkers and proteomic profiles in sputum, blood, urine, and nasal lavage, associated with eosinophilic asthma and non-eosinophilic asthma.
Background summary
N/A
Study objective
1. Exhaled molecular profiling will discriminate eosinophilic asthma from non-eosinophilic asthma;
2. Exhaled molecular profiling is associated with biomarkers and proteomic profiles in sputum, blood, urine and nasal lavage.
Study design
1. Screening visit; -28 to -14 days;
2. Collection of samples; 0.
Intervention
1. Lungfunction;
2. Sputum induction;
3. Collection of exhaled air;
4. Blood withdrawal;
5. Nasal lavage;
6. Collection of urine.
Inclusion criteria
1. Age >18 years;
2. Clinical presentation of asthma;
3. Airway hyperresponsiveness, indicated by a positive methacholine challenge with PC20 8 mg/ml OR;
4. Reversibility in FEV1 of ≥ 12% predicted;
5. Requiring inhaled corticosteroids at high doses (≥ 500 ug ICS fluticasone or equivalent);
6. Non-smoking or stopped smoking more than 12 months ago and 10 pack years or less;
7. No condition or treatment which may increase the risk of bleeding;
8. No other clinically significant abnormality on history and clinical examination;
9. Able to give written and dated informed consent prior to any study-specific procedures.
Exclusion criteria
1. Change in the dose of ICS in 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 anti-leukotrienes, chromoglycates, anti-cholinergics within 4 weeks prior to the study;
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2238 |
| NTR-old | NTR2364 |
| Other | METC AMC : 09/326 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |