Fingerprints for inflammatory subtypes in asthma

Conditions: asthma
chronic inflammation of the airways
10024967

Registration Number: NL-OMON34697

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 40

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 < 1% * non-eosinophilic asthma

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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>eNose breathprints of eosinophilic and non-eosinophilic asthmatic subjects. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Specific molecular components that are associated with eosinophilic and<br /><br>non-eosinophilic asthma as determined by gas-chromatography and<br /><br>mass-spectrometry<br /><br>* Individual biomarkers and proteomic profiles in sputum, blood, urine, nasal<br /><br>lavage and nasal biopsies predictive for eosinophilic and non-eosinophilic<br /><br>asthma</p><br>