Ipratropium Bromide Spray as Treatment for Sialorrhea in Children

Sponsor

London Health Sciences Centre (Other)

Overall Status

Unknown status

CT.gov ID

NCT03747536

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Sialorrhea	Drug: Ipratropium bromide Other: Placebo	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2019

Anticipated Primary Completion Date :

Oct 1, 2019

Anticipated Study Completion Date :

Jan 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: Ipratropium bromide ipratropium bromide via metered dose spray (21 micrograms per spray) Other Names: Atrovent
Placebo Comparator: 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	Other: Placebo normal saline delivered via metered dose spray

Arm

Intervention/Treatment

Experimental: 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

Drug: Ipratropium bromide

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

Other Names:

Atrovent

Placebo Comparator: 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

Other: Placebo

normal saline delivered via metered dose spray

Outcome Measures

Primary Outcome Measures

Change in Drooling Severity and Frequency Scale [Change from baseline sialorrhea at 2 weeks following each treatment arm]
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 in Drooling impact scale [Change from baseline sialorrhea at 2 weeks following each treatment arm]
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.

Secondary Outcome Measures

Patient Global Impression of Improvement Scale [At start of trial and weekly self recording up to 8 weeks]
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
Adverse effect [Intermittent up to 8 weeks]
Documentation of all adverse effects encountered during study period
Patient feedback [Weekly self recording up to 8 weeks.]
Open ended patient comment related to the intervention. To be collected through patient booklet

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 18 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

London Health Sciences Centre

Investigators

Principal Investigator: Julie Strychowsky, MD, London Health Science Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Peng You, Principle Investigator, Department of Otolaryngology Head and Neck Surgery, Western University, London Health Sciences Centre

ClinicalTrials.gov Identifier:

NCT03747536

Other Study ID Numbers:

LondonHSC

First Posted:

Nov 20, 2018

Last Update Posted:

Nov 21, 2018

Last Verified:

Nov 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Peng You, Principle Investigator, Department of Otolaryngology Head and Neck Surgery, Western University, London Health Sciences Centre

Ipratropium bromide

Sialorrhea

Pediatric

Additional relevant MeSH terms:

Sialorrhea

Bromides

Ipratropium

Study Results

No Results Posted as of Nov 21, 2018