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.
ID
Bron
Verkorte titel
Aandoening
Asthma; Eosinophilic asthma; Asthma subtypes; biomarker
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
eNose breathprint of eosinophilic and non-eosinophilic astma.
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
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.
Onderzoeksopzet
1. Screening visit; -28 to -14 days;
2. Collection of samples; 0.
Onderzoeksproduct en/of interventie
1. Lungfunction;
2. Sputum induction;
3. Collection of exhaled air;
4. Blood withdrawal;
5. Nasal lavage;
6. Collection of urine.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2238 |
| NTR-old | NTR2364 |
| Ander register | METC AMC : 09/326 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |