Clinical trial NCT03747536: Ipratropium Bromide Spray as Treatment for Sialorrhea in Children
Official title: Ipratropium Bromide Spray as Treatment for Sialorrhea in Children: a Randomized, Double-blind, Placebo-controlled Crossover Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Sialorrhea
Keywords: Ipratropium bromide
Sialorrhea
Pediatric
Lead sponsor: London Health Sciences Centre
Sponsor class: OTHER
First posted: 2018-11-20
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Drooling Severity and Frequency Scale
timeFrame: Change from baseline sialorrhea at 2 weeks following each treatment arm
measure: Change in Drooling impact scale
timeFrame: Change from baseline sialorrhea at 2 weeks following each treatment arm
Secondary outcomes:
measure: Patient Global Impression of Improvement Scale
timeFrame: At start of trial and weekly self recording up to 8 weeks
measure: Adverse effect
timeFrame: Intermittent up to 8 weeks
measure: Patient feedback
timeFrame: Weekly self recording up to 8 weeks.
Other outcomes:
Locations:
Study officials:
affiliation: London Health Science Centre
name: Julie Strychowsky, MD
role: PRINCIPAL_INVESTIGATOR
References: