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

NCT05499572 | Completed

• 1 other identifier: NL82043.099.22
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Usability

Keywords

Parkinson

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (1)

• Inhaler preference of Parkinson patients

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

Study Arms (2)

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).

Device: Inhalation maneuver with placebo Inbrija and placebo Cyclops

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).

Device: Inhalation maneuver with placebo Inbrija and placebo Cyclops

Interventions

Inhalation maneuver with placebo Inbrija and placebo Cyclops DEVICE

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

Cyclops followed by Inbrija; Inbrija followed by Cyclops

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Parkinson's disease

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Martini Hospital Groningen: lead

Study Sites (1)

Martini Ziekenhuis

Groningen, 9728NT, Netherlands

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 12, 2022
• Study Start: February 29, 2024
• Primary Completion: July 2, 2024
• Study Completion: July 2, 2024
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)