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

NCT ID: NCT05499572

Last Updated: 2024-07-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 16 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-29
• Study Completion Date: 2024-07-02

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®.

Conditions

Usability

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Inbrija followed by Cyclops

During an off episode, patients will demonstrate both inhaler user maneuvers. The researcher will observe whether the steps are followed correctly. The handling time will be recorded as well. To see whether the patients prefer a certain inhaler and to see where this preference comes from, they need to fill in a questionnaire. The questionnaire will be filled in during or directly after the off episode. Dummy inhalers are used, so patients will only inhale air (no medication).

Inhalation maneuver with placebo Inbrija and placebo Cyclops

Intervention Type: DEVICE

Patients perform the inhalation maneuvers with placebo inhalers (Inbrija and Cyclops) during a Parkinson's off episode.

Cyclops followed by Inbrija

During an off episode, patients will demonstrate both inhaler user maneuvers. The researcher will observe whether the steps are followed correctly. The handling time will be recorded as well. To see whether the patients prefer a certain inhaler and to see where this preference comes from, they need to fill in a questionnaire. The questionnaire will be filled in during or directly after the off episode. Dummy inhalers are used, so patients will only inhale air (no medication).

Inhalation maneuver with placebo Inbrija and placebo Cyclops

Intervention Type: DEVICE

Patients perform the inhalation maneuvers with placebo inhalers (Inbrija and Cyclops) during a Parkinson's off episode.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Martini Hospital Groningen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Martini Ziekenhuis

Groningen, , Netherlands

Countries

Netherlands

Other Identifiers

NL82043.099.22

Identifier Type: -

Identifier Source: org_study_id