Phenotyping of patients who are in an early state of adult-onset asthma (< 1 year the physician diagnosis of asthma and > 18 year of age) by linking clinical, functional and non-invasive inflammatory markers will:*Reveal distinct risk factors…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
This is a descriptive study, without real outcome parameters. By performing
cluster analysis, several phenotypes of recent late onset asthma will be
defined.
Potential risk factors are assessed at baseline (phase 1) and related to the
change in lungfunction over time and exacerbation rate. Linear regression will
be used to analyse the association between potential predicting factors and
decline in FEV1 (ml.yr) and exacerbation rate during the follow-up. Logistic
regression will be used to estimate RR/OR with 95% CI*s for accelerated decline
in FEV1 and exacerbation rate.
Secondary outcome
n.v.t.
Background summary
Adult-onset asthma is a poorly understood, heterogeneous condition. It differs
from childhood-onset asthma in that it is often more severe, less responsive to
therapy and more likely to result in fixed airflow limitation. Several clinical
subtypes of adult onset asthma 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
persists despite corticosteroid treatment is a risk factor of severe disease
and accelerated decline in lung function, especially in the first years of the
disease
Study objective
Phenotyping of patients who are in an early state of adult-onset asthma (< 1
year the physician diagnosis of asthma and > 18 year of age) by linking
clinical, functional and non-invasive inflammatory markers will:
*Reveal distinct risk factors of severity and poor quality of life.
*Provide evidence that recent onset asthma in adulthood might be linked to
airway infection or linked to environmental factors.
Describe this cohort of patients during 2 years:
*To define risk factors of accelerated decline in lungfunction and
exacerbations frequency.
Study design
* Phase 1 will represent the baseline part of a longitudinal follow up study of
a cohort of 200 patients who are in an early stage of adult onset asthma. In
this study, the patients will be thoroughly characterized by clinical,
functional and inflammatory markers.
* Phase 2, prospective follow-up during 2 years.
Study burden and risks
Phase 1: The burden associated with these studies includes a hospital visit,
during which an intake interview, a physical examination, routine blood test,
lungfunction, exhaled nitric oxide measurement, exhaled volatile organic
compounds analysis (electronic nose) will be done. All subjects will also
perform sputum induction (for differenial cell counts and pathogen detection)
which in our own experience as well as based on literature is well tolerated
even by severe asthmatics.
Phase 2: During the follow-up the patient will visit the hospital every 6
months. During every visit an interview, physical examination, routine blood
test and short lungfunction test will be done.
The results of the study may be improtant for the group of asthmatic patients
as it will identify different subtypes of patients with recent adult-onset
asthma and unravel the underlying mechanisms, which will hopefully lead to
phenotype-spefific therapies that might improve outcome in this neglected group
of patients. Thus might also help to reduce the personal and socioeconomic
burden of the disease.
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
- 18 to 75 years
- Adult-onset asthma (i.e. asthma that started after the age of 18)
- Physicians diagnosis of asthma < 1 year prior enrolment
- Documented reversibility in FEV1 of > 12 % predicted and 200 ml or airway hyperresponsiveness to inhaled methacholine (PC20 < 8 mg/ml)
Exclusion criteria
- Patients with smoking history > 10 packyears, fixed airflow obstruction (post bronchodilator FEV1 < 80%) and reversibility in FEV1 < 12% predicted.
- Pregnancy
- Other pulmonary diseases or non-related major-comobidities.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL27379.018.09 |