SialorrheaPhase 2NCT03747536
Ipratropium Bromide Spray as Treatment for Sialorrhea in Children
A Phase 2 study testing Ipratropium bromide in people with Sialorrhea, run by London Health Sciences Centre.
Trial summary
Double-blind, clinical trial investigating the effects of ipratropium spray versus placebo spray in children with sialorrhea Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Sialorrhea
- What is being tested?
- Ipratropium bromide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2019to 1 Jan 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children and adolescents aged 5-18 with a history of excessive drooling
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
Agnieszka Dzioba, PhD contact
About this study
Official title: Ipratropium Bromide Spray as Treatment for Sialorrhea in Children: a Randomized, Double-blind, Placebo-controlled Crossover Study
Double-blind, clinical trial investigating the effects of ipratropium spray versus placebo spray in children with sialorrhea
Read the 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.
- Conditions
- Sialorrhea
- Being tested
- Ipratropium bromide, Placebo
- Keywords
- Ipratropium bromide, Sialorrhea, Pediatric
- Medical subject headings
- Sialorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ipratropium bromideDrug
Also called Atrovent
ipratropium bromide via metered dose spray (21 micrograms per spray)
PlaceboOther
normal saline delivered via metered dose spray
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from baseline sialorrhea at 2 weeks following each treatment arm
Secondary outcomes (3)
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
Measured: At start of trial and weekly self recording up to 8 weeks
Adverse effect
Documentation of all adverse effects encountered during study period
Measured: Intermittent up to 8 weeks
Patient feedback
Open ended patient comment related to the intervention. To be collected through patient booklet
Measured: Weekly self recording up to 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start1 Jan 2019 (estimated)
- Primary completion1 Oct 2019 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SialorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peng You, London Health Sciences Centre
- Investigators
- Julie Strychowsky, MD, Principal investigator, London Health Science Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03747536
- Sponsor's protocol ID
- LondonHSC
- Status last verified
- Nov 2018
- First submitted
- 14 Nov 2018
- Last updated
- 21 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ipratropium Bromide Spray as Treatment for Sialorrhea in Children: a Randomized, Double-blind, Placebo-controlled Crossover Study
- ClinicalTrials.gov ID
- NCT03747536
- Acronym / sponsor ID
- LondonHSC
- Conditions
- Sialorrhea
- Keywords
- Ipratropium bromide, Sialorrhea, Pediatric
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- London Health Sciences CentreUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 20 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Double-blind, clinical trial investigating the effects of ipratropium spray versus placebo spray in children with sialorrhea
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Ipratropium bromideipratropium 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 |
| Placebo | Placebo comparator | Other: Placebonormal saline administered via metered dose spray. 1-2 spray sublingual or to buccal mucosa every 6 hours up to 4 times a day |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Children and adolescents aged 5-18 with a history of excessive drooling
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ipratropium bromideAlso: Atroventipratropium bromide via metered dose spray (21 micrograms per spray) | Drug | Intervention |
| Placebonormal saline delivered via metered dose spray | Other | Placebo |
Primary outcome
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.
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.
3 secondary outcomes
Patient Global Impression of Improvement Scale
Time frame: At start of trial and weekly self recording up to 8 weeks
Adverse effect
Time frame: Intermittent up to 8 weeks
Patient feedback
Time frame: Weekly self recording up to 8 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agnieszka Dzioba, PhD contact
Julie Strychowsky, MD principal investigator
London Health Science Centre
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ipratropium bromide in people with Sialorrhea, run by London Health Sciences Centre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julie Strychowsky, MD (519 685 8500 ext. 58242, julie.strychowsky@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Drooling Severity and Frequency Scale (time frame: Change from baseline sialorrhea at 2 weeks following each treatment arm). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2018.