|- candidate number||5884|
|- NTR Number||NTR1838|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||4-jun-2009|
|- Secondary IDs||08/358 MEC AMC|
|- Public Title||Adult Onset Asthma: the first 5 years.|
|- Scientific Title||Adult Onset Asthma: the first 5 years.|
|- hypothesis||Phenotyping of patients with adult onset asthma by linking clinical, functional and molecular markers will:|
1. Reveal distinct risk factors of severity and poor quality of life;
2. Provide evidence that recent onset asthma in adulthood is relatively more severe;
3. Show that different subtypes of adult onset asthma can be identified by specific functional or non-invasive inflammatory markers.
|- Healt Condition(s) or Problem(s) studied||Severe asthma, Adults|
|- Inclusion criteria||1. Age between 18-75 years;|
2. Physicians diagnosis of asthma after age of 18;
3. Physicians diagnosis of asthma >1 year prior enrolment;
4. Documented reversibility in FEV1>12% and 200 ml or Airway hyperresponsiveness to inhaled methacholine (PC20<8mg/ml) or
Diurnal variation in PEF of >20% (with twice daily reading >10%).
|- Exclusion criteria||1. Smoking history >10py and a fixed airflow obstruction (FEV1 <80%pb and FEV1/FVC<0.70pb) without reversibility in FEV1>12% and 200ml;|
3. Physician's diagnosis of asthma in childhood;
4. Other pulmonary diseases or non related major co-morbidities;
5. Diffusion capacity (TLCO/VA) <80%;
6. Episodes of dyspneu or multiple use of inhalde pulmonary medication in childhood (5-12yr).
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||22-jun-2009|
|- planned closingdate||31-dec-2011|
|- Target number of participants||200|
|- Primary outcome||Studie 1: Characterizing patients with adult onset asthma with respect to clinical, functional and inflammatory parameters. Subtypes will be defined by cluster analysis; risk factors of disease and poor quality of life will be defined.
Studie 2: Clinical, functional and inflammatory parameters will be compared between 100 patients with recent onset asthma (1-5yr) and 100 patients with longstading adult onset asthma (>5yr).
Studie 3: Three well defined subtypes will be compared by measurements of small airway function and sputum cells.
|- Secondary outcome||N/A|
|- Timepoints||All data will be collected during 1 visit.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| M. Amelink|
|- CONTACT for SCIENTIFIC QUERIES||MD, PhD Elisabeth H.D. Bel|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Department of Pulmonology|
(Source(s) of Monetary or Material Support)
|Netherlands Asthma Foundation|
|- Brief summary||Adult onset asthma is a poorly understood heterogeneous condition. It differs from childhood asthma that 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. Studies suggest that eosinophilic inflammation that persist despite corticosteroid treatment is a risk factor of severe disease and accelerated decline in lung function, especially in the first year of the disease. |
This project is the cross sectional part of a large scale longitudinal follow-up survey in patients with adult onset asthma. The objective of this part of the survey is to define different phenotypes and to detect risk factors of severity.
|- Main changes (audit trail)|
|- RECORD||4-jun-2009 - 30-sep-2009|