Clinical trial NCT05499572: Usability of Levodopa Cyclops™ vs INBRIJA® in Parkinson's Patients
Official title: Usability of Levodopa Cyclops™ Compared to INBRIJA® During an Off Episode in Parkinson's Disease Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Usability
Keywords: Parkinson
Lead sponsor: Martini Hospital Groningen
Sponsor class: OTHER
First posted: 2022-08-12
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Parkinson's disease

Brief 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. This study investigates if Parkinson patients have a preference for one of the inhalers based on handling steps, ease-of-use, understandability.

Detailed description: Sixteen Parkinson's patients, who are ≥ 18 years of age, regularly suffering from predictable off episodes, able to understand the inhaler user instructions (no cognitive dysfunction) and who did not previously participate in the Parkinson DPI-1,2,3,4 or 5 study or in a study using INBRIJA®.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with Parkinson's disease by a neurologist;
* At least 18 years of age;
* Regularly suffering from predictable off episodes despite 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.

Primary outcomes:
measure: Correct performance of inhalation maneuvers
timeFrame: 15 minutes for performing the inhalation maneuvers with both the placebo inhalers (Inbrija and Cyclops) during a Parkinson's off episode
Secondary outcomes:
measure: Inhaler preference of Parkinson patients
timeFrame: 10 minutes for filling in the questionnaire during or directly after a Parkinson's off episode
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: Martini Ziekenhuis
Study officials:
References: