Our main objective is the characterization and comparison of interactions/ phenotype differences in DCs, Th cells and ILC2s obtained from asthma patients with controlled, partly controlled and uncontrolled clinical symptoms and healthy controls.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
astma patiënten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Cell numbers and activation of Th subsets, DCs, ILC2s and granulocytes will be
determined in peripheral blood and induced sputum of controlled, partly
controlled and uncontrolled asthma patients and healthy controls.
Secondary outcome
- To compare the differences in activation status in DCs, and to identify
correlations with immunological and clinical disease phenotype
- To compare the differences in activation status in T cell subsets, and to
identify correlations with immunological and clinical disease phenotype
- To establish whether T helper cell polarization by DCs is altered in asthma
patients
- To find correlations between ILC2 numbers and characteristics and
immunological and clinical disease phenotype
Background summary
Asthma is a chronic heterogeneous disease of the airways. Patients with
controlled asthma are characterized by a T helper (Th) 2 mediated eosinophilic
inflammation, while uncontrolled asthma patients often display a neutrophilic
inflammation, associated by Th17 cells. Different immune cells, such as
dendritic cells (DCs), Th cells, Group 2 innate lymphoid cells (ILC2s) and
granulocytes play an important role in the pathology of both controlled and
uncontrolled asthma. Therefore differences in the numbers of these immune cells
as well as their activation states could provide more insight in
differentiating controlled from uncontrolled asthma.
Study objective
Our main objective is the characterization and comparison of interactions/
phenotype differences in DCs, Th cells and ILC2s obtained from asthma patients
with controlled, partly controlled and uncontrolled clinical symptoms and
healthy controls.
Study design
In this study we aim to investigate cell number, phenotype, activation and gene
expression in different immune cells in peripheral blood and induced sputum of
controlled, partly controlled and uncontrolled asthma patients and healthy
controls.
Study burden and risks
From asthma patients peripheral blood and induced sputum are taken during
visitation. We estimate that participation in this study will pose a minimal
additional risk of complications and patient discomfort. For healthy
volunteers, withdrawal of peripheral blood and induced sputum is reported to be
a safe procedure. Participants will not have direct personal benefit from
participating in this study. The results from this study could be beneficial
for the patient population. Healthy volunteers will receive a financial
compensation.
Dr. Molewaterplein 50
Rotterdam 3015 GE
NL
Dr. Molewaterplein 50
Rotterdam 3015 GE
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet one of the following criteria:
- Diagnosis of asthma confirmed by at least one of the following as assessed at least once during the 5 past years before the study:
- 1. Reversibility to β2-agonists as shown by an increase from baseline in FEV1>= 12% predicted and >= 200 ml after 400 µg inhaled salbutamol or equivalent;
- 2. Bronchial hyper-responsiveness (BHR) to metacholine (PD < 1.76) or histamine (PD < 2.59) as measured by standardized methods.
- 3. Peak-flow variability of >20% ((PEFmax - PEFmin)/PEFmax) over a period of 14 days.
- 4. Fall in FEV1>12% and >200ml when tapering of treatment (ICS, oral steroid, LABA and/or LTRA). ;We will include patients diagnosed with asthma and a recent (< 12 monts) metacholine provocation test, or histamine provocation test (PD20 < 1.76 mg). These test are performed in a standardized manner in both centers.
o In this study we will compare three different asthmatic phenotypes. These phenotypes will be determined based on clinical features and inflammatory sputum profile;
- Use inhaled corticosteroids daily and β2-agonists as required;
- Given written informed consent;
- Age: 18 - 50.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:;- received systemic corticosteroid therapy (>= 7.5 mg/kg) within three months prior to inclusion;
- no use of inhaled corticosteroids and β2-agonists
- BMI > 35;
- Smoking > 10 pack years;
- Other diseases which could influence pulmonary function and/or the immune system such as:
o A possible infection of the upper- or lower respiratory tract 4 weeks prior to the collection of materials;
o Chronic obstructive pulmonary disorder (COPD) in the medical history;
o Auto-immune diseases such as systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), myasthenia gravis or Goodpasture*s syndrome;
o Malignancies;
o Human immunodeficiency virus (HIV);
o Pregnancy;
o Other allergies except for allergic rhinitis.
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 | NL50922.078.14 |