Ipratropium Bromide Spray as Treatment for Sialorrhea in Children

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

Detailed Description
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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.

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

Conditions
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Sialorrhea

Intervention / Treatment
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* Drug: Ipratropium bromide
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* ipratropium bromide via metered dose spray (21 micrograms per spray)<br>* Other names: Atrovent;|
| Placebo Comparator: Placebo<br>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<br>* normal saline delivered via metered dose spray<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Adverse effect | Documentation of all adverse effects encountered during study period | Intermittent up to 8 weeks | 
| Patient feedback | Open ended patient comment related to the intervention. To be collected through patient booklet | Weekly self recording up to 8 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ipratropium bromide, Sialorrhea, Pediatric