The primary objective is to investigate whether Parkinson*s patients are able to produce an optimal inhalation technique for the Cyclops® inhaler in their home situation after first and second inhalation instruction. The secondary objective is to…
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 Parkinson*s patients are
able to reproduce an optimal inhalation technique for the Cyclops® inhaler by
measuring the pressure drop (kPa), breath hold time (sec.) and inhaled volume
(L) after first and second inhalation instruction.
Secondary outcome
The secondary study parameter is to investigate whether Parkinson*s patients
perform the correct steps in accordance with the patient instruction card with
the Cyclops® inhaler after first and second inhalation instruction.
Background summary
Very limited treatment options are available with a rapid onset to counter off
periods in Parkinson*s disease patients. Therefore, the development of rapid
onset levodopa formulations is warranted, for which an inhalable formulation of
levodopa is being investigated. It is important to know whether Parkinson*s
patients used the inhalable formulation correctly in their home situation a
couple weeks after instruction. Since the inhalable formulation will only be
used during off periods, the frequency of which can vary from a few times a
week to a few times a day (opposed to inhalation medication for pulmonary
disorders that are used daily).
Study objective
The primary objective is to investigate whether Parkinson*s patients are able
to produce an optimal inhalation technique for the Cyclops® inhaler in their
home situation after first and second inhalation instruction. The secondary
objective is to investigate if Parkinson*s patients understand the patient
instruction card and follow the steps correctly.
Study design
Non-therapeutic observational study.
Study burden and risks
The inhaler that will be used is a dummy without drug or excipient, so the
Parkinson*s patients will not inhale anything but air during the test and
during the exercises. The burden is minimal as the procedure is limited to
practice one inhalation per day.
Per Parkinson*s patient, the study is limited to three test moments that lasts
maximally 30 minutes per test moment. This observational study has no specific
benefits for the participating Parkinson*s patients. Only when performed in
this population, information on Parkinson*s patients can be obtained.
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 nerologist;
- At least 18 years of age;
- Signed informed consent.
Exclusion criteria
- Not able to understand inhalation instruction (within a maximum of 30
minuten).
- Previously participated in the Parkinson DPI-1, DPI-2 or DPI-3 studie (prior
knowledge of the inhalation maneuver);
- Active pulmonary disease.
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 | NL69706.099.19 |