A Phase 2 interventional study of Ipratropium bromide and Placebo in Sialorrhea, sponsored by London Health Sciences Centre. Status unknown. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2018-11-21.
Sponsored by London Health Sciences Centre · Phase 2, Interventional, and Treatment
Double-blind, clinical trial investigating the effects of ipratropium spray versus placebo spray in children with sialorrhea
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.
60 studies on the registry are indexed under Sialorrhea; 5 are open to participants now.
This study's planned enrollment of 30 is close to the median of 31 across 44 interventional studies indexed under Sialorrhea.
Browse Sialorrhea studies →London Health Sciences Centre is the lead sponsor of 39 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
ipratropium bromide via metered dose spray (21 micrograms per spray)
Also known as: Atrovent
normal saline delivered via metered dose spray
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.
Time frame: 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.
Time frame: Change from baseline sialorrhea at 2 weeks following each treatment arm
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
Time frame: At start of trial and weekly self recording up to 8 weeks
Adverse effect
Documentation of all adverse effects encountered during study period
Time frame: Intermittent up to 8 weeks
Patient feedback
Open ended patient comment related to the intervention. To be collected through patient booklet
Time frame: Weekly self recording up to 8 weeks.
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ipratropium
London Health Sciences Centre