Parkinson Parkinson's disease
Conditions
Interventions
None listed
Sponsors
Martini Ziekenhuis
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed