Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00296946
Status:
COMPLETED
Last Update Posted:
2018-02-20
First Post:
2006-02-23
Brief Title:
Ipratropium Spray for Drooling Saliva in Parkinsons Disease
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Phase II Clinical Trial of Ipratropium Bromide Spray as a Treatment for Sialorrhea in Patients With Parkinsons Disease
Status:
COMPLETED
Status Verified Date:
2004-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A phase II double blind clinical trial investigating the effects of ipratropium spray versus placebo spray in patients with Parkinsons disease
Detailed Description:
Background Excessive drooling of saliva sialorrhoea is a common complication of Parkinsons 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 Parkinsons 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
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 Parkinsons 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None