Ipratropium Spray for Drooling Saliva in Parkinson's Disease

This study has been completed.
Sponsor:
Collaborator:
Parkinson's Disease Foundation
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00296946
First received: February 23, 2006
Last updated: November 15, 2006
Last verified: October 2004
  Purpose

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


Condition Intervention Phase
Parkinson's Disease
Drug: ipratropium bromide (drug)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Phase II Clinical Trial of Ipratropium Bromide Spray as a Treatment for Sialorrhea in Patients With Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • objective measure of saliva production.

Secondary Outcome Measures:
  • subjective measure of saliva using diaries
  • UPDRS parts I – IV
  • adverse events

Estimated Enrollment: 20
Study Start Date: November 2004
Estimated Study Completion Date: June 2006
Detailed 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 g 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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

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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. -

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00296946

Locations
Canada, Ontario
Toronto Western Hospital, University Health Network
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
University Health Network, Toronto
Parkinson's Disease Foundation
Investigators
Principal Investigator: Susan H Fox, MRCP, PhD University Health Network, Toronto, Canada
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00296946     History of Changes
Other Study ID Numbers: FY2005
Study First Received: February 23, 2006
Last Updated: November 15, 2006
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
Sialorrhoea

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Bromides
Ipratropium
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014