Ipratropium Bromide Spray as Treatment for Sialorrhea in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2021-01-01

Brief Summary

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Double-blind, clinical trial investigating the effects of ipratropium spray versus placebo spray in children with sialorrhea

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Detailed Description

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Excess drooling, or sialorrhea, is a chronic problem seen in pediatric patients with oral-motor dysfunction or neurodevelopmental abnormalities. Despite significant social and physical detriment from sialorrhea, an effective and safe treatment remains elusive.

The investigator's objective is to study the effect of sublingual ipratropium (an anticholinergic aerosol spray) on sialorrhea in the pediatric population

Method: A double-blind, randomized, placebo-controlled cross-over trial of sublingual ipratropium bromide application in pediatric patients with inappropriate drooling. Patients are recruited from the sialorrhea clinic and informed consent is obtained. Patients are randomized to receive ipratropium bromide, 1- 2 metered doses (sprays) of active drug (21 micrograms per metered dose) or matching placebo, every 6 hours up to a maximum of 4 times per day, in a double-blind, cross-over design using randomization tables. Total treatment length is two weeks for each limb of the study with a 2 week washout period. The primary outcome measure is the reporting of sialorrhea using a validated scales. Secondary outcome includes global assessment of treatment, patient satisfaction, and adverse effects.

Conditions

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Sialorrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study drug will be dispensed as a metered-dose spray bottle of ipratropium bromide or identical placebo prepared by the Hospital Pharmacy. Clinician, investigator, care provider, as well as outcome assessor will be blinded to the treatment.

Study Groups

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Intervention

ipratropium bromide administered via metered dose spray (21 micrograms per spray). 1-2 spray sublingual or to buccal mucosa every 6 hours up to 4 times a day

Group Type EXPERIMENTAL

Ipratropium bromide

Intervention Type DRUG

ipratropium bromide via metered dose spray (21 micrograms per spray)

Placebo

normal saline administered via metered dose spray. 1-2 spray sublingual or to buccal mucosa every 6 hours up to 4 times a day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

normal saline delivered via metered dose spray

Interventions

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Ipratropium bromide

ipratropium bromide via metered dose spray (21 micrograms per spray)

Intervention Type DRUG

Placebo

normal saline delivered via metered dose spray

Intervention Type OTHER

Other Intervention Names

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Atrovent

Eligibility Criteria

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Inclusion Criteria

* Children and adolescents aged 5-18 with a history of excessive drooling

Exclusion Criteria

* known hypersensitivity to ipratropium bromide
* surgery for sialorrhea within one year
* the concurrent use of acetylcholinesterase inhibitors, cholinergic agents, or anticholinergic agents
* botulinum toxin for drooling within the preceding six months
* a history of glaucoma
* the presence of clinically significant urinary retention or outflow obstruction as evidenced by patient history or documented urodynamic studies

Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No