Symptom scores and pollen monitoring by hay fever patients (SYMPOL)

For many people, a sunny day in spring or summer means a day with itchy, watery
eyes and/or a runny or blocked nose. The pollen in the air on those days causes
the nose and eye symptoms in people who are sensitized to that pollen.
Importantly, a substantial proportion of individuals with hay fever suffer from
severe symptoms, causing impaired quality of life and reduced performance at
school and work (Walker et al. 2007). Since so many individuals suffer from hay
fever and since these symptoms are frequently associated with other
inflammatory diseases such as asthma, the impact and costs for society are
significant (Zuberbier et al. 2014).
Symptoms of hay fever sufferers can be monitored by mobile applications and
these symptom scores can be related to daily pollen counts supplied by the LUMC
(de Weger et al. 2014; de Weger et al. 2011). Currently, these pollen are being
counted using a static sampler that is located on the roof of the 6th floor of
the LUMC. Little is known about the pollen concentrations that individuals are
exposed to. This pilot study aims to correlate symptoms in hay fever sufferers
to the measurement of pollen concentrations in the direct environment of the
individual.
This study is part of the project *Nie(t)s is te gek*, which is a collaborative
study between the University of Applied Science in Leiden (Hogeschool Leiden),
Generade, Leiden University Medical Center (Department of Pulmonology and Human
Genetics) and the Leidse Instrumentmakers School. In this project, a handheld
pollen sampler was developed, that can collect pollen in the direct environment
of the subjects thus enabling personalized monitoring of pollen exposure. This
handheld pollen sampler is called pollensniffer. The pollen will be quantified
by microscopic counting. Within the project a new analysis method is being
developed. When this method is available the samples can be analysed by this
new method too. In this pilot study, we aim to investigate (i) whether the
amount of grass pollen collected by the handheld pollensniffer correlates with
the symptoms of individuals; and (ii) the user-friendliness of the
pollensniffer.
For this pilot we aim to recruit 10 participants with hay fever. The
sensitization pattern of these study subjects will be tested by a blood test to
assess pollen-specific IgE. Only individuals positive for grass pollen will be
recruited. These subjects will be asked to (1) monitor their environment in the
morning when they go to school or work during approximately 15 min; (2) score
their hay fever symptoms by using an app; and (3) not use hay fever medication.

The present pilot study is essential for further development of personalized
pollen monitoring, and we aim to use the results in publications and for future
grant applications.

Primary Objective: Evaluate the relationship between the amount of pollen
collected in the environment of the hay fever sufferers using a handheld
sniffer and the symptoms of these subjects.

This pilot study is designed as an observational, single center trial, with a
total of 10 participants (n=10).

Visit 1:
* Informed consent: An Informed Consent will be obtained prior to subject*s
participation. The subject will be given sufficient time to make an informed
decision about participating in this trial.
* Anamnesis: (i) demographic data (ii) screening of their medical history
(general and on allergy) (iii) medication use
* a general physical examination and a nasal examination to exclude chronically
blocked nose
* Blood collection for the screening of specific IgE on inhalation allergens
Visit 2:
A joint meeting will be organized where the participants to the study will
receive instructions on:
* How to use the pollensniffer
* How to change the samples in the sample holder
* The selection of the 2 weeks to measure the pollen and to score the symptoms;
this selection will be made at the start of the grass pollen season and
announced during the instruction meeting (or earlier if known).
* How to register symptom scores using the mobile application
* Subjects will be instructed not to use any medication for their allergic
symptoms starting 3 days before the measurements until the last measurement.
When this medication cessation leads to severe symptoms, the participants can
contact the research team that will provide information on rescue medication.
In this case the individual will have to leave the study.
Visit 3:
* Intake of the pollensamples and the pollensampler and completion of a
questionnaire

The burden consists of one bloodsample, three site visits, physical
examination, completion of a questionnaire. Furhtermore the partiicpants will
have to collect pollen using the pollensniffer for two weeks during 15 min a
day and score their symptoms.

The risk are estimated to be minimal.