No registrations found.
ID
Source
Brief title
Health condition
Non-atopic asthma
Adults
Niet-atopisch astma
Volwassenen
Sponsors and support
Intervention
Outcome measures
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
Background 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.
Study objective
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.
Study design
All data will be collected in two visits, which will be less than 2 weeks apart.
Intervention
N/A
J.C. Groot, de
Leeuwarden 8934 AD
The Netherlands
+31 (0)58 2863874
christa.de.groot@znb.nl
J.C. Groot, de
Leeuwarden 8934 AD
The Netherlands
+31 (0)58 2863874
christa.de.groot@znb.nl
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;
2. Pregnancy;
3. Other pulmonary diseases or non-related major co-morbidities.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2100 |
| NTR-old | NTR2217 |
| CCMO | NL29219.099.09 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON33169 |