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Inhaled glycopyrronium on excessive sialorrhea and drooling

The effect of inhaled glycopyrronium bromide on excessive sialorrhea and drooling in Parkinson Disease: a dose finding study

Status
Active, not recruiting
Phases
Unknown
Study type
Unknown
Source
NL-OMON
Registry ID
NL-OMON27582
Enrollment
10
Registered
2016-12-08
Start date
2017-01-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sialorrhea, drooling, Parkinson Disease. Speekselvloed, kwijlen, Ziekte van Parkinson

Interventions

The participant will use 4 different dosing regimes of glycopyrronium inhalation powder. Three times a day a drooling score must be filled. Patients must record adverse events and other special events

Sponsors

Medisch Spectrum Twente, Enschede
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosed with Parkinson disease Moderate to severe sialorrhea, defined as a minimum of 4 of the Mier scale Age > 18 years Able to fill the scoring table (or the partner/carer must be able to)

Exclusion criteria

Exclusion criteria: Hypersensitivity to glycopyrronium or other excipients Use of medication with known anticholinergic effects.

Design outcomes

Primary

MeasureTime frame
The safety and tolerability of glycopyrronium inhalation powder in patients diagnosed with sialorrhea and parkinson disease, measured in adverse events and other special events that occur.

Secondary

MeasureTime frame
Het mean difference in drooling between different dosing regimes and the patient preference.

Contacts

Public ContactJ.B. Masselink

Koningsplein 1, Enschede

j.masselink@mst.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)