OBJECTIVE: To investigate the safety and tolerability of glycopyrronium inhalation powder using different dosing regimens and to determine the decrease of drooling in patients with Parkinson's disease. DESIGN: We conducted a 5-week safety study. METHODS: Following a baseline week, each participant used glycopyrronium inhalations during four weeks, with weekly changing dosing regimes. The safety and tolerability was determined by monitoring side effects and the experience of participants. The decrease in drooling was determined by comparing the mean sialorrhea scores obtained every week. An interim analysis was performed after including seven participants. RESULTS: Side effects occurred in 71.4% of participants, which led to discontinuation of the study in three out of seven participants. The most common side effects were coughing and headache. Side effects that caused discontinuation were a swollen tongue, dry mouth, and gastro-enteritis. No unknown side effects of glycopyrronium led to discontinuation. Four participants experienced improvement in sialorrhea and three participants continued inhalation treatment after completion of the study. Two participants mentioned an instant effect after inhalation of glycopyrronium. CONCLUSION: Despite the reported side effects and the fact that we performed an interim analysis, we believe that glycopyrronium inhalations could be considered after failing of oral therapy.
|Number of pages||4|
|Publication status||Published - 14 Dec 2018|