NCT03747536

Ipratropium Bromide Spray as Treatment for Sialorrhea in Children

Ipratropium Bromide Spray as Treatment for Sialorrhea in Children: a Randomized, Double-blind, Placebo-controlled Crossover Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: London Health Sciences Centre · Academic / Other
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Sialorrhea

Interventions

Type	Name	Description
DRUG	Ipratropium bromide	ipratropium bromide via metered dose spray (21 micrograms per spray)
OTHER	Placebo	normal saline delivered via metered dose spray

Timeline

• Start date: 2019-01-01
• Primary completion: 2019-10-01
• Completion: 2021-01-01
• First posted: 2018-11-20
• Last updated: 2018-11-21