The primary objective is to determine whether there is a difference in the capability of the patients to successfully follow the instructions of both the Levodopa Cyclops* and the INBRIJA® inhaler during an off episode, based on the instruction…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is to investigate whether PD patients perform the
correct steps in line with the instruction card of respectively the Levodopa
Cyclops* or INBRIJA® inhaler after the primary inhalation instructions and to
collect information about problems experienced during the inhalation maneuver.
Secondary outcome
The secondary study parameter is to collect information about the opinion of PD
patients regarding the ease-of-use and convenience of the different steps of
the inhaler user maneuver of both inhalers.
Background summary
Currently there is one Levodopa inhaler on the market, the INBRIJA® inhaler.
When looking at the user instructions for the INBRIJA®, multiple steps are
necessary including preparing and cleaning the inhaler. The Levodopa Cyclops*
inhaler also requires steps to be ready-for-use, however there are less steps
required to reach this *ready-for-use* state. This is mainly because the
medicine (Levodopa) is already prefilled in the inhaler. Moreover, the Levodopa
Cyclops* is a single-use inhaler and cleaning steps are not necessary. Since
both inhalers should be used during off episodes, there might be a preference
for one inhaler over the other due to the instructions. An off episode might
impair the ability and length to successfully operate an inhaler due to mental
or mobility issues.
Study objective
The primary objective is to determine whether there is a difference in the
capability of the patients to successfully follow the instructions of both the
Levodopa Cyclops* and the INBRIJA® inhaler during an off episode, based on the
instruction cards of both inhalers.
The secondary study parameter is to collect information about the opinion of PD
patients regarding the ease-of-use and convenience of both inhalers by filling
in a questionnaire.
Study design
A crossover non-therapeutic observational study.
Study burden and risks
The inhalers that will be used are dummy inhalers without drug of excipient, so
the Parkinson's patients will not inhale anything but air during the test. The
burden is minimal as the tests consists of performing an inhalation maneuver
during an off episode and filling in the questionnaire. Per Parkinson's
patient, the study is limited to one test moment which takes approximately 2
hours. This observational study has no specific benefits for the participating
Parkinson's patients. Performing the test in this population is necessary to
obtain information on Parkinson's patients.
Van Swietenplein 1
Groningen 9728 NT
NL
Van Swietenplein 1
Groningen 9728 NT
NL
Listed location countries
Age
Inclusion criteria
- Diagnosed with Parkinson*s disease by a neurologist;
- At least 18 years of age;
- Regularly suffering from predictable off episodes despite PD medication;
- Recognizable off episodes for themselves and others;
- Signed informed consent.
Exclusion criteria
- Not able to understand an inhalation instruction of either the Levodopa
Cyclops* or the INBRIJA® (within a maximum of 20 minutes of explanation per
inhaler);
- Cognitive dysfunction, which precludes good understanding of instructions
and/or informed consent;
- Previously participated in the Parkinson DPI-1, DPI-2, DPI-3, DPI-4 or DPI-5
study (prior knowledge of the inhalation maneuver of the Levodopa Cyclops*)
- Having experience with using the INBRIJA® inhaler.
Design
Recruitment
Medical products/devices used
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 | NL82043.099.23 |