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ID
Source
Brief title
Health condition
Parkinson's disease
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
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 design
At the first appointment (T=0) the patient receives an inhalation instruction with a dummy Cyclops® inhaler. The instructions will be given verbally and partly be demonstrated by the instructor, partly be visualised by photographs on the patient instruction card and recordings of generated flow curves on a computer screen.
At the second appointment (T=1), two weeks (± 2 days) after the first appointment and at the third appointment (T =2), four weeks (± 4 days) after the second appointment, patients will be will be visited by the investigator and will be asked to demonstrate their inhalation technique with a dummy Cyclops® equipped with a pressure drop meter.
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
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL8102 |
| Other | RTPO 1081 : 69706.099.19 |