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Trial record 1 of 150 for:    Ipratropium OR atrovent
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Ipratropium Bromide Spray as Treatment for Sialorrhea in Children

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ClinicalTrials.gov Identifier: NCT03747536
Recruitment Status : Not yet recruiting
First Posted : November 20, 2018
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
Peng You, London Health Sciences Centre

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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine


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 Name: 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




Primary Outcome Measures :
  1. Change in Drooling Severity and Frequency Scale [ Time Frame: 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.

  2. Change in Drooling impact scale [ Time Frame: 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 :
  1. Patient Global Impression of Improvement Scale [ Time Frame: 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

  2. Adverse effect [ Time Frame: Intermittent up to 8 weeks ]
    Documentation of all adverse effects encountered during study period

  3. Patient feedback [ Time Frame: Weekly self recording up to 8 weeks. ]
    Open ended patient comment related to the intervention. To be collected through patient booklet



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03747536


Contacts
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Contact: Julie Strychowsky, MD 519 685 8500 ext 58242 julie.strychowsky@lhsc.on.ca
Contact: Agnieszka Dzioba, PhD Agnieszka.Dzioba@lhsc.on.ca

Sponsors and Collaborators
London Health Sciences Centre
Investigators
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Principal Investigator: Julie Strychowsky, MD London Health Science Centre

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Responsible Party: Peng You, Principle Investigator, Department of Otolaryngology Head and Neck Surgery, Western University, London Health Sciences Centre
ClinicalTrials.gov Identifier: NCT03747536     History of Changes
Other Study ID Numbers: LondonHSC
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peng You, London Health Sciences Centre:
Ipratropium bromide
Sialorrhea
Pediatric
Additional relevant MeSH terms:
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Ipratropium
Sialorrhea
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Bromides
Anticonvulsants
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action