The effect of INhaled Glycopyrronium bromide on Excessive Sialorrhea and Drooling in Parkinson disease: a dose finding study

The effect of INhaled Glycopyrronium bromide on Excessive Sialorrhea and Drooling in Parkinson disease: a dose finding study - Inhaled glycopyrronium on excessive sialorrhea and drooling (INGESD)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45524

Enrollment

Registered

2017-04-12

Start date

2017-05-01

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 and drooling

Interventions

Following a baseline week, each participant will use glycopyrronium inhalations during four weeks. Every week the dosing regimen change: starting with one time daily inhalation of 44 µg glycopyrroni

Drooling

Glycopyrronium

Inhalation

Sialorrhea

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Diagnosed with Parkinson disease Moderate to severe sialorrhea, defined as a minimum of 4 on 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

Measure	Time frame
The primary endpoint is the determination of the safety and tolerability of glycopyrronium inhalations in PD patients with sialorrhea.	—

Secondary

Measure	Time frame
The secondary endpoints are to determine mean difference in loss of saliva between dosing regimens and baseline week and to investigate the preferred method of treatment by patients.	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)