Skip to main content
OpenTrials
Completed

NCT Number: NCT05499572

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Usability

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Martini Ziekenhuis

Groningen, 9728NT, Netherlands

About this study

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®.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Correct performance of inhalation maneuvers

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

    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.

Secondary outcomes

  1. Inhaler preference of Parkinson patients

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

    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

Sponsors and collaborators

Lead sponsor

Martini Hospital Groningen

Other

Registry information

Official study title

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

Acronym: DPI-6

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 12, 2022
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.