Ipratropium Bromide Spray as Treatment for Sialorrhea in Children

Sialorrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03747536
• Other study ID #: LondonHSC
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 1, 2019
• Est. completion date: January 1, 2021

Study information

• Verified date: November 2018
• Source: London Health Sciences Centre
• Contact: Julie Strychowsky, MD
• Phone: 519 685 8500
• Email: julie.strychowsky[@]lhsc.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 1, 2021
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Sialorrhea

Intervention

Drug:
• Ipratropium bromide
ipratropium bromide via metered dose spray (21 micrograms per spray)

Other:
• Placebo
normal saline delivered via metered dose spray

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
London Health Sciences Centre

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Drooling Severity and Frequency Scale	Also referred to as the Thomas Stonell and Greenberg scale. This is a validated tool using patient reported scores for drooling severity and frequency. Drooling severity is scored on a scale with minimum value of 1 and maximum value of 5. A higher value represents a worse outcome. The frequency is scored on a scale with minimum value of 1 and maximum value of 4. A higher value represents a worse outcome. The subscales (severity and frequency) can be interpreted independently or combined through addition to compute a total score.	Change from baseline sialorrhea at 2 weeks following each treatment arm
Primary	Change in Drooling impact scale	The drooling impact scale is a validated self-administered questionnaire used to measure saliva-control in children. The scale consists of 10 questions/subscales, each with a minimum score of 1 and a maximum score of 10. For all subscales, the higher value represents a worse outcome. The total score is reported and is calculated by adding the score of all 10 subscales.	Change from baseline sialorrhea at 2 weeks following each treatment arm
Secondary	Patient Global Impression of Improvement Scale	The Patient Global Impression of improvement scale is a single 7-point scale that requires the patient/caregiver to assess how much the illness has improved or worsened relative to a baseline state at the beginning of the intervention. The minimum score is 1 and the maximum score is 7. A higher value represents a worse outcome. To be collected through patient booklet	At start of trial and weekly self recording up to 8 weeks
Secondary	Adverse effect	Documentation of all adverse effects encountered during study period	Intermittent up to 8 weeks
Secondary	Patient feedback	Open ended patient comment related to the intervention. To be collected through patient booklet	Weekly self recording up to 8 weeks.