The primary objective is to determine from what age on children can operate a test inhaler correctly (handling). The secondary objectives are to determine whether children can generate a sufficiently large airflow and volume through the test inhaler…
ID
Source
Brief title
Condition
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the ability of a child to understand how to use the
inhaler correctly.
Secondary outcome
The parameter that describes whether or not a child is capable of using the
inhaler correctly is the pressure drop (s)he creates over the inhaler upon
inhalation, from which various inspiratory parameters can be calculated.
Furthermore, the presence of a blockage in the mouth upon inhalation will be
observed as function of the inhaler design (mouthpiece and resistance).
Background summary
The department of Pharmaceutical Techonology and Biopharmacy works on improving
drug delivery to the lungs, mainly focussing on severe diseases, e.g. cystic
fibrosis (CF). CF is a chronic, life shortening, genetic disease and the
complications associated with this disease occur already at a young age. One of
these are ever-recurring lung infections, which are the main cause for the
patient*s early death. Early, effective treatment might prevent or postpone the
transition into a chronic infection. Currently, lung infections in CF are
treated with nebulised antibiotics. However, the currently used nebulisers
have several disadvantages, like a low lung deposition efficacy and a long
administration time (up to 20-30 min twice daily). Therapy with a dry powder
inhaler (DPI) has the potential to be superior over nebulisation, but its
applicability in children has not been tested systematically yet. The
development of a DPI that better suits the needs of children, based on their
intellectual and inspiratory capacities, is essential. In this study, we will
investigate the applicability of dry powder inhalation in school children in
order to enable us to develop a DPI specifically for this patient group.
Study objective
The primary objective is to determine from what age on children can operate a
test inhaler correctly (handling). The secondary objectives are to determine
whether children can generate a sufficiently large airflow and volume through
the test inhaler for dispersion of a medicinal powder in relationship to their
age or height, and which resistance and type of mouthpiece are most favourable
for, respectively accepted by children.
Study design
Non-therapeutic observational study.
Study burden and risks
The risks of participating in the study are negligible. The inhaler used is a
specially designed dummy without drug or excipient, so the child will not
inhale anything but air during the test. The burden is minimal as the
procedures are limited to five registered inhalations only (and the opportunity
to practise). Furthermore, the test will be performed under the least
burdensome and stressful conditions, i.e. at the children*s own primary school,
which is a known and safe environment for the children, and during school
hours. Per child, the test is limited to one test moment that lasts maximally
30 minutes. This observational study has no specific benefits for the
participating (healthy) children. Only when performed in this population, group
related information on the intellectual and inspiratory capacities of school
children can be obtained.
Antonius Deusinglaan 1
9713 AV Groningen
NL
Antonius Deusinglaan 1
9713 AV Groningen
NL
Listed location countries
Age
Inclusion criteria
• Registered at the primary school
• Informed consent of parent(s)/guardian(s)
• Assent of the child
Exclusion criteria
No exclusion criteria are formulated. In principle, all children registered at the primary school are eligible to participate.
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 | NL39283.042.12 |