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Inflammatory subtypes in asthma.


- candidate number8127
- NTR NumberNTR2364
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-jun-2010
- Secondary IDs09/326 METC AMC
- Public TitleInflammatory subtypes in asthma.
- Scientific TitleInflammatory subtypes in asthma.
- ACRONYMNEON
- hypothesis1. 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.
- Healt Condition(s) or Problem(s) studiedAsthma, Biomarkers, Eosinophilic asthma
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-jul-2010
- planned closingdate1-jul-2011
- Target number of participants40
- Interventions1. Lungfunction;
2. Sputum induction;
3. Collection of exhaled air;
4. Blood withdrawal;
5. Nasal lavage;
6. Collection of urine.
- Primary outcomeeNose breathprint of eosinophilic and non-eosinophilic astma.
- Secondary outcomeIndividual biomarkers and proteomic profiles in sputum, blood, urine, and nasal lavage, associated with eosinophilic asthma and non-eosinophilic asthma.
- Timepoints1. Screening visit; -28 to -14 days;
2. Collection of samples; 0.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. A.H. Wagener
- CONTACT for SCIENTIFIC QUERIESDrs. A.H. Wagener
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
GlaxoSmithKline
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD8-jun-2010 - 20-jun-2010


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