The primary objective is to investigate the safety and tolerability of inhalation of glycopyrronium inhalation powder using different dosing regimens. The second objectives are to determine the decrease in drooling by using different dosing regimens…
ID
Source
Brief title
Condition
- Salivary gland conditions
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the determination of the safety and tolerability of
glycopyrronium inhalations in PD patients with sialorrhea.
Secondary outcome
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.
Background summary
Sialorrhea is reported in up to 75 percent of PD patients. Physical and
psychosoclal complications of sialorrhea range from mild and inconvenient
symptoms to severe problems that can have a significant negative Impact on
quality of life. Glycopyrronium solution is prescribed to decrease sialorrhea
in patients with Parkinson's Disease. The solution must be ingested thrice a
day. Arbouw et al proved this solution is effectlve In Parkinsonian patients
who suffer from sialorrhea. There are also patients who don't experience any
benefits from using the glycopyrronium solution. This could be explained
because the gastro-intestinal tract in PD-patients might be affected, resulting
in poor absorption of the solution. There are also patients who experience
severe side effects, like dry mouth, which ultimately leads to discontinuation.
In 2013 glycopyrronium was released as an inhalation powder for patients who
suffer from chronic obstructive pulmonary disease. A common side effect that
was seen during clinical research was a dry mouth. This side effect could be
usefull in patients with sialorrhea. During advanced disease patients
experience off-periods unexpected. This can come together multiple episodes of
sialorrhea a day.
Study objective
The primary objective is to investigate the safety and tolerability of
inhalation of glycopyrronium inhalation powder using different dosing regimens.
The second objectives are to determine the decrease in drooling by using
different dosing regimens of glycopyrronium inhalation powder and to
investigate the preferred method of treatment by patients.
Study design
A 5-week dose finding study to determine the optimal dose for glycopyrronium
inhalation use in PD patients suffering from sialorrhea.
Intervention
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 glycopyrronium, followed by two time daily inhalation
of 50 µg glycopyrronium, then a three time daily inhalation of 44 µg
glycopyrronium, and during week 4 participants can use glycopyrronium on demand
(zero to four times a day).
Study burden and risks
Drooling can have a major impact on parkinsonian patients. The current
standard-of-care oral solution of glycopyrronium is suboptimal for some
patients. Therefore research is needed in this population.
Koningsplein 1
Enschede 7512KZ
NL
Koningsplein 1
Enschede 7512KZ
NL
Listed location countries
Age
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
Hypersensitivity to glycopyrronium or other excipients
Use of medication with known anticholinergic effects
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2016-004162-26-NL |
| CCMO | NL59782.044.17 |
| Other | nnb |