NCT05499572

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

Usability of Levodopa Cyclops™ Compared to INBRIJA® During an Off Episode in Parkinson's Disease Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 16 (actual)
• Sponsor: Martini Hospital Groningen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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®.

Conditions

• Usability

Interventions

Type	Name	Description
DEVICE	Inhalation maneuver with placebo Inbrija and placebo Cyclops	Patients perform the inhalation maneuvers with placebo inhalers (Inbrija and Cyclops) during a Parkinson's off episode.

Timeline

• Start date: 2024-02-29
• Primary completion: 2024-07-02
• Completion: 2024-07-02
• First posted: 2022-08-12
• Last updated: 2024-07-25

Locations

1 site across 1 country: Netherlands