|- candidate number||7764|
|- NTR Number||NTR2217|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||15-feb-2010|
|- Secondary IDs||NL 29219.099.09 CCMO|
|- Public Title||Phenotypes of Adults with Non-Atopic Asthma.|
|- Scientific Title||Phenotypes of Adults with Non-atopic Asthma; Mechanisms and Aetiology.|
|- hypothesis||Characterization of subjects with non-atopic asthma and phenotyping of the disease by linking clinical, functional and molecular markers will:|
1. Give more insight in the underlying pathophysiological mechanisms of non-atopic asthma;
2. Show that different subtypes of non-atopic asthma can be identified by specific functional or non-invasive inflammatory markers;
3. Reveal distinct risk factors of severity and poor quality of life.
|- Healt Condition(s) or Problem(s) studied||Adults, Non-atopic asthma|
|- Inclusion criteria||1. Outpatients with non-atopic asthma, determined by negative alatop;|
2. Age 18 yrs or older;
3. Pulmonologist's diagnosis of asthma;
4. Documented reversibility in FEV1 of >= 12% predicted OR airway hyperresponsiveness to inhaled methacholine.
|- Exclusion criteria||1. Patients with smoking history of > 10 packyears and persistent airflow obstruction (post bronchodilator FEV1 < 80%pred): excluded if reversibility in FEV1 < 12% predicted OR TLCO< 80%pred;|
3. Other pulmonary diseases or non-related major co-morbidities.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-jan-2010|
|- planned closingdate||1-jan-2012|
|- Target number of participants||200|
|- Primary outcome||Study 1: Characterizing patients with non-atopic asthma with respect to clinical, functional and inflammatory parameters. Separate subtypes of non-atopic asthma will be defined by unbiased cluster analysis.
Study 2: The association between level of NO in exhaled air, percentage of eosinophils in induced sputum and extent of sinus disease as assessed by CT sinus score will be investigated by correlation analyses.
Study 3: Sensitivity, specificity, positive and negative predictive value of the eNose in detecting sinus disease in non-atopic asthma.
|- Secondary outcome||N/A|
|- Timepoints||All data will be collected in two visits, which will be less than 2 weeks apart.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| J.C. Groot, de|
|- CONTACT for SCIENTIFIC QUERIES|| J.C. Groot, de|
|- Sponsor/Initiator ||Medical Center Leeuwarden |
(Source(s) of Monetary or Material Support)
|Stichting Longgeneeskunde Fryslan|
|- Brief summary||Non-atopic asthma is a poorly understood heterogeneous condition and it is often more severe, less responsive to therapy and more likely to result in fixed airflow limitation. Several clinical subtypes have been described but it is unknown whether these are associated with distinct types of airway inflammation, responses to therapy or disease outcome. |
This project is a cross sectional survey in patients with non-atopic asthma.
The objective of this study is to define different phenotypes and to detect risk factors of severity.
|- Main changes (audit trail)|
|- RECORD||15-feb-2010 - 26-feb-2010|