*What children want and what they do: a real life study of the consistency and sustainability of the inhalation technique monitored with homemade video clips*.

Asthma is the most common chronic lung disease in childhood and characterized
by airway inflammation, airway hyper responsiveness and reversible airflow
obstruction.
Management of asthma exists of educational and therapeutic interventions.
Educational interventions are necessary to improve adherence, inhalation
technique and self-management of patients.
Correct use of inhalers is essential in asthma treatment, however they are
often used suboptimal. Repeated instructions lead to a better technique in the
doctor*s office but it is not sure that this reflects the way patients use
their inhalers at home. Live demonstration of inhalation technique shows how
well a child can perform in front of a health care professional and their
caregivers. Parents regularly report that the technique in the home situation
is worse than the child shows at the outpatient clinic, potentially reducing
the therapeutic benefit and increasing the risk of adverse events. Both
outcomes may in turn compromise adherence.
There are several training tools available for training the patients in the
correct use of pressured Metered-Dose-Inhalers (pMDI*s) and Dry Powder Inhalers
(DPI*s). One of these tools, the Inhalation Manager®, offers the opportunity
for computer-based measurement of the entire inspiratory maneuver with several
devices. This can help during instruction sessions to improve and check
objectively the quality of the inhalation technique.
In recent years children have become used to communicate via digital channels,
for example by sending video clips to each other. The introduction of Wi-Fi,
tablets and smart phones have made it easy to connect digitally wherever you
are. This gives us the opportunity to investigate the inhalation technique in
the home situation.
Two inhalation technique studies in children have checked pMDI with Valved
Holding Chamber (VHC) to several DPI*s as used in the doctor*s office. In the
CHESS-study children were instructed to send a video clip once a week of the
recorded inhalation technique that was scored with standardized checklists and
provided with feedback through e-mail. There was already a good inhalation
technique at the start of the study, for respectively DPI and pMDI-VHC 82,5%
and 86,7%, due to an intense training program in asthma management before
starting this study. Therefore the inhalation technique improved for
respectively DPI and pMDI-VHC 92,8% and 94% during the year. However the number
of uploaded videos was low, only one third of the expected videos were uploaded
to the web site. Also this study did not analyze the difference in inhalation
technique at the doctor*s office compared with the home situation.
The study of Kamps et al showed that after three instruction sessions during
approximately 24 weeks all children using DPI or pMDI-VHC improved their
inhalation technique as demonstrated in a hospital. At the initial visit only
25% of the newly referred DPI users and 76% of the pMDI-VHC users showed a
correct inhalation technique. At the end of the study period the inhaler
technique improved to respectively to 95-100%.
To our knowledge there is no study that has assessed daily inhalation technique
in children in the home situation comparing two often prescribed breath
actuated devices.
The aim of this study is to investigate the differences in sustainability of
the inhalation technique of two often prescribed devices in children aged 6-18
years in the home situation. Secondary aims are to investigate the reliability
of inhalation technique as demonstrated in a hospital compared with inhalation
technique as videotaped in the home and to investigate the influence of the use
of the Inhalation Manager® on the preference for device of a Nurse practitioner

Main objective:
To investigate Differences in sustainability of inhalation technique of Diskus®
and Autohaler® in the home situation. This will be measured with the inhalation
checklist for the Diskus® and Autohaler®.

Secondary objectives:
* To investigate the relationship of inhalation technique as demonstrated in
the hospital with inhalation technique as videotaped at home in asthmatic
children.
* To investigate the preference of device for a child before and after the
study period.
* To investigate what determines the choice of device for a child before and
after the study period.
* To investigate the preference of device of the Nurse Practitioner (NP) before
and after the use of an Inhalation Manager®.

This study will be a prospective observational study.
Children will be randomly instructed to use the Diskus® and Autohaler® or vice
versa once daily by a NP. Group 1 will use Flixotide 100 µg Diskus® in the
morning and Qvar 100 µg in the evening, group 2 vice versa. Children will
receive a Flixotide 100µg Diskus® and Qvar 100µg Autohaler® to use at home
after showing a good inhalation technique for both devices. Children are
instructed at visit 1 how to record and send their daily video clips of the
inhalation for both devices with an iPad®. If the child does not e-mail his/her
inhalations he/she will receive an electronic reminder from the NP on the
IPad®. If a child does not mail the video clips for more than three consecutive
days or more than three times a week he/she will be excluded from this study.
After 4 weeks the child is invited to the outpatient clinic to demonstrate
his/her inhalation technique with both devices. The inhalation technique will
be scored with standardized inhalation protocols designed by the Lung Alliance
Netherlands (LAN) by the NP.

The risks of participation are considered minimal. Both inhaled corticosteroids
are registered for children aged 6-18 years old and proven to be of therapeutic
benefit for children with the diagnosis asthma. Risk for side effects is equal
for both inhaled steroids, also most of the children who will be included in
this study already used inhaled corticosteroids as maintenance medication in
the same dosage.
Patients have to make a daily recording of their inhalation with both devices.
They can make the recording with the iPad® which they can use freely during
this research. Recording the inhalation technique with both devices and sending
the video to the NP will take five minutes per day. After four weeks using both
devices children come to the outpatient clinic for evaluation. The benefit is
that the switch to a new inhaler device can be based on the performance of
inhalation technique in the home situation. Also we will see if the live check,
which is the appropriate in the treatment of asthma, gives enough information
to choose the correct device for the child.
Besides our expectation is that participation in the study will result in
better adherence to maintenance medication and improve control of asthma,
implying that this study may not alone be of diagnostic but also of therapeutic
relevance. This study has to be performed in children with asthma, because
pulmonary deposition of inhaled medication in children is easily compromised as
children have smaller airways and lower inspiratory flow. Inhaled medication
has been developed and evaluated for adults.
As far as we know there are no studies that have compared the rate of
deterioration of inhalation technique in children using Diskus® or Autohaler®
in the home situation.