The main objective is to determine whether children with CF are able to achieve an inhalation manoeuvre as required for aerosol generation and transport into the peripheral airways with the test inhaler. The secondary objectives are to determine…
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 achieve a proper
inhalation manoeuvre with the test inhaler, which is reflected in the pressure
drop they create over the inhaler upon inhalation.
Secondary outcome
From the (duration of the) pressure drop, various inspiratory parameters will
be calculated per airflow resistance. The incidence of obstructions in the oral
cavity upon inhalation will be expressed as percentage of the total number of
observations.
Background summary
The department of Pharmaceutical Technology and Biopharmacy works on improving
drug delivery to the lungs, in particular for severe diseases like cystic
fibrosis (CF). The complications associated with CF occur already at a young
age, of which ever-recurring lung infections are the main cause for the
patient*s early death. Early, effective treatment of these infections might
prevent or postpone the transition into a chronic infection. The current
treatment of lung infections in CF with nebulised antibiotics has several
disadvantages, like a low lung deposition efficacy and a long administration
time. Therapy with a dry powder inhaler (DPI) has the potential to be superior
over nebulisation, but limited literature is available on DPI applicability in
children. We conducted a study in healthy school children to determine their
cognitive and inspiratory capacities concerning dry powder inhalation by use of
a test inhaler (ChildDPI-1, METc no. 2011-281). The present follow-up study
will investigate DPI applicability in children with CF by a comparable
approach, in which we narrowed down the number of airflow resistances and
mouthpiece designs to those that appeared most suitable for and most favoured
by healthy children.
Study objective
The main objective is to determine whether children with CF are able to achieve
an inhalation manoeuvre as required for aerosol generation and transport into
the peripheral airways with the test inhaler. The secondary objectives are to
determine which of three resistance modes, which of two mouthpiece designs are
most suitable for children with CF, and whether an exacerbation influences the
child*s ability to perform a proper inhalation manoeuvre.
Study design
Non-therapeutic, observational study.
Study burden and risks
The risks of participating in the study are negligible. The inhaler used is a
dummy without drug or excipient, so the child inhales nothing but air during
the test. The burden is minimal as the procedures are limited to the
performance of six inhalations (and practice), which will be performed on the
day of their routine check-up at the clinic. There are one or two test moments
per child that last maximally 30 minutes at a time. Participation has no direct
benefit for the children. Only when performed in this population, group related
information on the cognitive and inspiratory capacities of children with CF can
be obtained.
Antonius Deusinglaan 1
Groningen 9713 AV
NL
Antonius Deusinglaan 1
Groningen 9713 AV
NL
Listed location countries
Age
Inclusion criteria
- A physician*s diagnosis of CF
- 4 to 14 years of age
- Informed consent from the parent(s)/guardian(s)
- Assent from the child (informed consent when >=12 years of age)
Exclusion criteria
No exclusion criteria are formulated.
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 | NL47385.042.14 |