To assess whether TW and PW show differences in number, phenotype or function of regulatory T-cells in peripheral blood samples. Details on study determinants will be based on the outcome of the pilotstudy (Regulatory T cells in asthma; PREDART0807…
ID
Source
Brief title
Condition
- Respiratory disorders congenital
- Autoimmune disorders
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Study endpoint: transient or persistent wheezing (= asthma) at age 6 years.
Study determinants: number, phenotype and functionality of regulatory T cells
in the peripheral blood of early wheezers at age 3 and 5 years. Details on
study determinants will be based on the outcome of the pilotstudy (Regulatory T
cells in asthma; ABR nummer 19836) preceding the analysis of the samples of
this prospective study.
Secondary outcome
Secondary determinants:
Questionnaires: WRC (Weekly Record Card) and questionnaire based upon the ISAAC
and PIAMA studies.
Lung function: RINTat the age of 3,4,5 and 6 years of age; Volume flow curves
before and after β2-mimetics at the age of 6 years.
eNose measurement at the age of 3 and 6 years.
Peripheral blood: cell numbers and Immunoglobin E levels (total and specific
IgE for most common food and inhalent allergens).
Background summary
Of all newborns, 33% suffer from at least one period of wheezing before the age
of 3 years. Of these so-called early wheezers (EW), only 40% will continue to
wheeze between the age of 3 and 6 years (persistent wheezers=PW). At the age of
6 years PW, also designated to have asthma, can be differentiated from
so-called transient wheezers (TW) who did not continue to wheeze. Attempts to
differentiate PW from TW in early infancy have so far failed. In this project
proposal we hypothesize that Tregs play a role in the development of asthma and
that TW and PW differ in either number, phenotype or functionality of Tregs.
Study objective
To assess whether TW and PW show differences in number, phenotype or function
of regulatory T-cells in peripheral blood samples. Details on study
determinants will be based on the outcome of the pilotstudy (Regulatory T cells
in asthma; PREDART0807) preceding the analysis of the samples of this
prospective study.
Furthermore differences in lung function and eNose measurements of transient
and persistent wheezers will be assessed between the age of 3 and 6 years.
Study design
Etiological observational longitudinal study with a follow-up of 3 years.
Study burden and risks
The risks and burden for subjects in this study are considered negligible.
Blood will be taken at the same time as routine blood withdrawal, as much as
possible. A maximum of one blood sample at the age of 3 and 5 years will be
taken as part of this study, also once yearly a full physical examination and
lung function test will be performed. At the age of 3 and 6 years an eNose
measurement will be performed. Furthermore a questionnaire will be filled out
and 4 times a year during 2 weeks a weekly record card (WRC) will be filled
out.
Lundlaan 6
3584 AE Utrecht
NL
Lundlaan 6
3584 AE Utrecht
NL
Listed location countries
Age
Inclusion criteria
patient is early wheezer
patient is 3 years of age
Exclusion criteria
The use of systemic immune modulating medication at the time of blood withdrawal and/or 6 weeks before blood withdrawal. The presence of an active infection at the time of blood withdrawal.
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 | NL16411.041.07 |