Ipratropium Spray for Drooling Saliva in Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

Phase II Clinical Trial of Ipratropium Bromide Spray as a Treatment for Sialorrhea in Patients With Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00296946
• Other study ID #: FY2005
• Status: Completed
• Phase: Phase 2
• First received: February 23, 2006
• Last updated: February 16, 2018
• Start date: November 2004
• Est. completion date: June 2006

Study information

• Verified date: October 2004
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A phase II double blind clinical trial investigating the effects of ipratropium spray versus placebo spray in patients with Parkinson's disease.

Description:

Background: Excessive drooling of saliva (sialorrhoea) is a common complication of Parkinson's disease (PD). Unfortunately current medications, which rely on anticholinergic properties, often induce systemic side effects, such as confusion, hallucinations or urinary retention.

Aim: We therefore hypothesise that local application of an anticholinergic aerosol spray into the mouth would reduce sialorrhea in PD without inducing systemic side-effects.

Method: A double blind, randomised, placebo-controlled cross-over trial of the muscarinic antagonist, ipratropium bromide in patients with bothersome drooling in idiopathic Parkinson's disease. All patients are recruited from the Movement Disorders Clinic, Toronto Western Hospital and informed consent is obtained. Patients are randomised to receive ipratropium bromide, 1- 2 metered doses (sprays) of active drug (21 micorgram per metered dose) or matching placebo, up to a maximum of 4 times per day, in a double-blind, cross-over design using randomisation tables. Total treatment length is two weeks for each limb of the study with a 1-2 week wash out period. The primary outcome measure is an objective measure of saliva production. Dental rolls are inserted into the mouth for 5 min and the patient instructed not to swallow and sit upright. The weight of dental rolls before and after insertion is calculated as a measure of saliva production. The secondary outcome measures are subjective measure of saliva where patients or caregivers record the level of saliva production each day for the 2 weeks of each treatment using validated subjective rating scales which assess drooling severity and frequency. In addition, parkinsonism is rated using the UPDRS parts I - IV and adverse events are recorded. The scores for measured saliva production following ipratropium bromide and placebo treatment will be compared using appropriate paired t-tests. Results from the scales assessing the subjective measures of saliva production and UPDRS ratings will be compared via paired non-parametric Wilcoxon matched pairs test. 20 patients will be recruited.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:Male and female patients with idiopathic PD and who are currently experiencing bothersome drooling (United Parkinson's Disease Rating Scale (UPDRS) item 6, rating of 2 or higher) will be eligible for this study. Patients must be on a stable medication regimen for the preceding one-month run-in period. In addition, patients or a caregiver must be able to complete a daily record card, and patients must be able to tolerate an oral dental roll for 5-minute periods for saliva measurements.

Exclusion Criteria:

Patients taking acetylcholinesterase inhibitors, cholinergic agents, or anticholinergic agents, history of glaucoma, clinically significant urinary outflow obstruction or urinary retention, active psychosis or hallucinations, and allergy to peanuts or soybeans. -

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• ipratropium bromide (drug)

Locations

Country	Name	City	State
Canada	Toronto Western Hospital, University Health Network	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Parkinson's Disease Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objective measure of saliva production.
Secondary	subjective measure of saliva using diaries
Secondary	UPDRS parts I - IV
Secondary	adverse events