Usability of Levodopa Cyclops™ vs INBRIJA® in Parkinson's Patients

Martini Hospital Groningen16 enrolled

Overview

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.

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®.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Usability

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Correct performance of inhalation maneuvers

The main study parameter is to investigate whether Parkinson's patients perform the correct steps in accordance with the instruction card of respectively the Levodopa Cyclops™ or INBRIJA® inhaler after the primary inhalation instructions.

Time frame: 15 minutes for performing the inhalation maneuvers with both the placebo inhalers (Inbrija and Cyclops) during a Parkinson's off episode

Secondary Outcomes

Inhaler preference of Parkinson patients

The secondary study parameter is to investigate whether the Parkinson's patients prefer the Levodopa Cyclops™ or the INBRIJA® inhaler by keeping track of the total handling time and by letting the patients fill in a questionnaire keeping track of their experiences regarding the ease-of-use, convenience and preference of the different steps of the inhaler user maneuver

Time frame: 10 minutes for filling in the questionnaire during or directly after a Parkinson's off episode