Ipratropium Bromide Spray as Treatment for Sialorrhea in Children

NCT03747536 | Unknown Phase 2 DMC

• 1 other identifier: LondonHSC
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Sialorrhea

Keywords

Ipratropium bromide; Sialorrhea; Pediatric

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Patient Global Impression of Improvement Scale

  At start of trial and weekly self recording up to 8 weeks

• Adverse effect

  Intermittent up to 8 weeks

• Patient feedback

  Weekly self recording up to 8 weeks.

Study Arms (2)

Intervention

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Ipratropium bromide DRUG

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

Also known as: Atrovent

Intervention

Placebo OTHER

normal saline delivered via metered dose spray

Placebo

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children and adolescents aged 5-18 with a history of excessive drooling

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre: lead

MeSH Terms

Conditions

Sialorrhea

Interventions

Ipratropium

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Julie Strychowsky, MD

  London Health Science Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Strychowsky, MD

CONTACT

519 685 8500; julie.strychowsky@lhsc.on.ca

Agnieszka Dzioba, PhD

CONTACT

Agnieszka.Dzioba@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator, Department of Otolaryngology Head and Neck Surgery, Western University

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: November 20, 2018
• Study Start: January 1, 2019
• Primary Completion: October 1, 2019
• Study Completion: January 1, 2021
• Last Updated: November 21, 2018

Record last verified: 2018-11