UsabilityDPI-6NCT05499572
Usability of Levodopa Cyclops™ vs INBRIJA® in Parkinson's Patients
An observational study of Usability, run by Martini Hospital Groningen at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Usability
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteNetherlands
- Study dates
- 29 Feb 2024to 2 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Parkinson's disease
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Usability of Levodopa Cyclops™ Compared to INBRIJA® During an Off Episode in Parkinson's Disease 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.
Read the 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
- Being tested
- Inhalation maneuver with placebo Inbrija and placebo Cyclops
- Keywords
- Parkinson
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhalation maneuver with placebo Inbrija and placebo CyclopsDevice
Patients perform the inhalation maneuvers with placebo inhalers (Inbrija and Cyclops) during a Parkinson's off episode.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Device: Inhalation maneuver with placebo Inbrija and placebo Cyclops |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: 10 minutes for filling in the questionnaire during or directly after a Parkinson's off episode
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start29 Feb 2024
- Primary completion2 Jul 2024
- Study completion2 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UsabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martini Hospital Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05499572
- Sponsor's protocol ID
- NL82043.099.22
- Acronym
- DPI-6
- Status last verified
- Jul 2024
- First submitted
- 8 Aug 2022
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability of Levodopa Cyclops™ Compared to INBRIJA® During an Off Episode in Parkinson's Disease Patients
- ClinicalTrials.gov ID
- NCT05499572
- Acronym / sponsor ID
- DPI-6 / NL82043.099.22
- Conditions
- Usability
- Keywords
- Parkinson
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Martini Hospital GroningenUniversity, hospital or other
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- 2 Jul 2024 (actual)
- Study completion
- 2 Jul 2024 (actual)
- First posted
- 12 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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®.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inbrija followed by Cyclops | – | Device: Inhalation maneuver with placebo Inbrija and placebo CyclopsDuring 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). |
| Cyclops followed by Inbrija | – | Device: Inhalation maneuver with placebo Inbrija and placebo CyclopsDuring 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Parkinson's disease
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhalation maneuver with placebo Inbrija and placebo CyclopsPatients perform the inhalation maneuvers with placebo inhalers (Inbrija and Cyclops) during a Parkinson's off episode. | Device | Cyclops followed by Inbrija, Inbrija followed by Cyclops |
Primary outcome
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.
1 secondary outcome
Inhaler preference of Parkinson patients
Time frame: 10 minutes for filling in the questionnaire during or directly after a Parkinson's off episode
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Usability, run by Martini Hospital Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.