We will study the differences of nasal epithelial cells of patients who respond vs. who do not respond successfully to the immunotherapy for grass pollen. With this knowledge we can in the future predict or patients will respond successfully or not…
ID
Source
Brief title
Condition
- Allergic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The differences between the expression at the RNA level in nasal mucosa and the
possibility to predict the effect of immunotherapy with specific expression
profiles.
Secondary outcome
VAS score during nasal provocation before and after immunotherapy
Quantitative skin prick test before and after immunotherapy
Background summary
Allergy is a common disease. Patients respond to innocent materials in their
surroundings, like grass pollen or house dust mite. The symptoms are aspecific,
like a runny or stuffy nose, sneezing and running eyes. These symptoms have a
big impact on the daily live of the patient. There are medicine which suppress
the symptoms, but they do not cure the disease. An alternative is treatment
with immuno therapy (IT). With IT, the materials that cause the symptoms are
injected subcutaneously. This way, the body gets used to these allergens so the
will hopefully cause less symptoms and at the end not anymore at all.
This method, which successful used as treatment for allergies and asthma has
also disadvantages. The treatment period is long, about a year, the injections
are unpleasant and the results of the treatment are not predictable.
Study objective
We will study the differences of nasal epithelial cells of patients who respond
vs. who do not respond successfully to the immunotherapy for grass pollen. With
this knowledge we can in the future predict or patients will respond
successfully or not.
Study design
All participants will get a skin prick test to begin with. The study will take
a year, in which the participants have to visit the hospital regularly. At the
first visit we will perform a nasal biopsy with local anaesthesia. Then we will
start the immunotherapy with grass pollen. The first seven injections are given
weekly and with an increasing dose of grass pollen, so the body can slowly get
used to the grass pollen. Depending of the response to the injections, after
seven weeks the injections will be given at monthly basis. After a year we
evaluate the effect of the immunotherapy.
Study burden and risks
All participants risk a small nose bleeding after the nasal biopsy. The
allergic participants will develop an allergic response after the nasal
provocation with grass pollen, comparable with the reaction after natural
exposure to grass pollen. There is a risk of a local or systemic reaction after
the immunotherapy, similar to the risk with clinical treatment with
immunotherapy.
All participants will be observed in the hospital for 30-45 minutes and get
clear instructions want to do at home when late reactions occur.
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Clinical relevant allergic rhinitis complaints caused by grass pollen
Exclusion criteria
Immunodeficiencies
Pregnancy
Severe heart and vasculair diseases
Renal failure
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 | NL36951.018.11 |