|- candidate number||25646|
|- NTR Number||NTR6223|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||8-dec-2016|
|- Secondary IDs||METC: P16-23. |
|- Public Title||Inhaled glycopyrronium on excessive sialorrhea and drooling|
|- Scientific Title||The effect of inhaled glycopyrronium bromide on excessive sialorrhea and drooling in Parkinson Disease: a dose finding study|
|- hypothesis||Glycopyrronium solution is used in patients suffering from sialorrhea and Parkinson Disease. The solution isn't sufficient enough for all patients due to to much effect or no effect at all. Glycopyrronium inhalation powder is used in patients with COPD, a common side effect is dry mouth. This gives us the hypothesis that it can be used in patients suffering from sialorrhea.|
|- Healt Condition(s) or Problem(s) studied||Parkinson's disease, Drooling|
|- 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||Hypersensitivity to glycopyrronium or other excipients|
Use of medication with known anticholinergic effects.
|- mec approval received||yes|
|- multicenter trial||no|
|- planned startdate ||1-jan-2017|
|- planned closingdate||1-jan-2018|
|- Target number of participants||10|
|- 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 that occur during the use of the inhalation powder. after the 3rd week of treatment a patient preference questionaire must be answered.|
|- Primary outcome||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 outcome||Het mean difference in drooling between different dosing regimes and the patient preference.|
|- Timepoints||T0: Inclusion
T1: week with once daily use of glycopyrronium|
T2: week with twice daily use of glycopyrronium
T3: week with three times a day use of glycopyrronium
T4: week with ondemand use of glycopyrronium with a maximum of 4.
|- Trial web site||none|
|- CONTACT FOR PUBLIC QUERIES|| J.B. Masselink|
|- CONTACT for SCIENTIFIC QUERIES|| J.B. Masselink|
|- Sponsor/Initiator ||Medisch Spectrum Twente|
(Source(s) of Monetary or Material Support)
|Medisch Spectrum Twente|
|- Brief summary||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.
Study population: Patients, age 18 or older, diagnosed with Parkinson’s disease with moderate to severe 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 44 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).
Main study parameters/endpoints: The primary endpoint is the determination of the safety and tolerability of glycopyrronium inhalations in PD patients with sialorrhea. 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.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: 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.
|- Main changes (audit trail)|
|- RECORD||8-dec-2016 - 2-apr-2017|