Ipratropium Bromide Spray as Treatment for Sialorrhea in Children

London Health Sciences Centre

Status and phase: Unknown; Phase 2

Conditions: Sialorrhea

Treatments: Drug: Ipratropium bromide; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03747536

LondonHSC

Details and patient eligibility

About

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

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

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

Treatment:

Drug: Ipratropium bromide

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo