WheezingViViNCT06093152
Video Assisted Study of Salbutamol Response in Viral Wheezing
An observational study of Wheezing, run by University of Oulu at 1 site in Finland.
Trial summary
The study is video assisted cross-over study evaluating the effect of inhaled salbutamol in wheeze in children 6-24 months old. Read more about this study
- Who is it for?
- Ages 6 to 24 months
- Conditions the study is for
- Wheezing
- What is being tested?
- Salbutamol
- How many people
- 50 participants
- Where
- 1 siteFinland
- Study dates
- 23 Oct 2023to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 6 to 24 months
- All sexes
- No healthy volunteers
- Child
Study population: Participants are 6-24 months old children presenting to the emergency department for wheezing.
Who may be able to join
- Wheezing
- Salbutamol-treatment in emergency department prescribed
Who cannot join
- Need for immediate resuscitation
- Immediate transfer to ICU
- Suspicion of pneumonia based on the auscultation finding
- Suspicion of airway foreign body
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Department of Pediatrics, Oulu University Hospital
Oulu, 90130
Ville Lindholm, MD, +35883155283, Ville.a.lindholm@student.oulu.fi
Terhi Tapiainen, MD, PhD, +358-8-315 5185, terhi.tapiainen@oulu.fi
About this study
The study is video assisted cross-over study evaluating the effect of inhaled salbutamol in wheeze in children 6-24 months old.
Read the detailed description
The object of the study is to evaluate the effect of inhaled salbutamol in wheeze in children 6-24 months old.
In despite of the lack of evidence of salbutamol, it is considered the gold standard in acute wheezing. Placebo-controlled study would be unethical so all participants are treated with salbutamol based on current guidelines. Instead, participants serve as control subjects of their own which is executed by a type video assisted cross-over study.
Participants are filmed before and after the treatment. Afterwards a panel of pediatricians not participating in the treatment of the participants independently evaluates the difficulty of the wheeze. Videos are randomly arranged and members of the panel are blinded to the time point (before/after) of videos.
In addition, collected videos are analyzed using machine vision. Biosignals are collected from the videos and evaluated using algorithms in order to show that machine vision can be utilized to evaluate the difficulty of wheezing. The machine vision analysis is compared to the evaluation of the panel of pediatricians.
- Conditions
- Wheezing
- Being tested
- Salbutamol
- Medical subject headings
- Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalbutamolDrug
Inhaled salbutamol (SABA, selective beta2-adrenergic receptor agonist) 0,1 mg 4-6 puffs 3-4 times every 20 minutes administered by OptiChamber holding chamber.
| Study group | Role | What they receive |
|---|---|---|
| Before salbutamol | Participants before the administration of salbutamol | |
| After salbutamol | Participants after the administration of salbutamol Receives: Drug: Salbutamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in modified RDAI
RDAI = Respiratory Distress Assessment Instrument, modified to not include auscultation findings. Range 0-18. Higher score indicates more difficult respiratory distress. Evaluated by the blinded panel afterwards using collected videos. Videos collected immediately before and after the intervention.
Measured: Within 3 hours of study entry
Secondary outcomes (4)
Change in saturation of peripheral oxygen
Change in saturation measured immediately before and after the intervention.
Measured: Within 3 hours of study entry
Change in auscultation finding
Evaluated by review of medical records (i.e. based on the findings of the physician treating the patient). Assessed as difficult (wheezing lasting all expiration and possibly inspiration in all 4 lung fields), medium (no inspiratory wheezing, lasting all expiratory OR in all lung 4 fields) of mild (no inspiratory wheezing, wheezing not lasting all expiratory and not in all lung fields). Assessed immediately before and after the intervention.
Measured: Within 3 hours of study entry
Change in the difficulty of the respiratory distress
Subjective evaluation of the respiratory distress based on the appearance of the patient on the video. Range 0-10, higher score indicating more difficult respiratory distress. Assessed by the blinded panel afterwards using videos collected immediately before and after the intervention.
Measured: Within 3 hours of study entry
Machine-vision assisted analysis of respiratory status
Machine vision analysis of the difficulty of wheezing (none - mild - difficult). Assessed using videos collected immediately before and after the intervention.
Measured: Within 3 hours of study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start23 Oct 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WheezingStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Terhi Tapiainen, University of Oulu
- Investigators
- Terhi Tapiainen, Professor, Principal investigator, University of Oulu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06093152
- Sponsor's protocol ID
- 223/2021
- Other IDs
- FIMEA/2023/003954
- Acronym
- ViVi
- Status last verified
- Feb 2025
- First submitted
- 5 Jul 2022
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Assisted Study of Salbutamol Response in Viral Wheezing
- ClinicalTrials.gov ID
- NCT06093152
- Acronym / sponsor ID
- ViVi / 223/2021
- Conditions
- Wheezing
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Oct 2023 (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.
The study is video assisted cross-over study evaluating the effect of inhaled salbutamol in wheeze in children 6-24 months old.
Detailed description
The object of the study is to evaluate the effect of inhaled salbutamol in wheeze in children 6-24 months old.
In despite of the lack of evidence of salbutamol, it is considered the gold standard in acute wheezing. Placebo-controlled study would be unethical so all participants are treated with salbutamol based on current guidelines. Instead, participants serve as control subjects of their own which is executed by a type video assisted cross-over study.
Participants are filmed before and after the treatment. Afterwards a panel of pediatricians not participating in the treatment of the participants independently evaluates the difficulty of the wheeze. Videos are randomly arranged and members of the panel are blinded to the time point (before/after) of videos.
In addition, collected videos are analyzed using machine vision. Biosignals are collected from the videos and evaluated using algorithms in order to show that machine vision can be utilized to evaluate the difficulty of wheezing. The machine vision analysis is compared to the evaluation of the panel of pediatricians.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before salbutamol | – | –Participants before the administration of salbutamol |
| After salbutamol | – | Drug: SalbutamolParticipants after the administration of salbutamol |
Who may qualify
- Ages
- 6 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Participants are 6-24 months old children presenting to the emergency department for wheezing.
Key inclusion criteria (2 listed)
- Wheezing
- Salbutamol-treatment in emergency department prescribed
Key exclusion criteria (4 listed)
- Need for immediate resuscitation
- Immediate transfer to ICU
- Suspicion of pneumonia based on the auscultation finding
- Suspicion of airway foreign body
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 |
|---|---|---|
| SalbutamolInhaled salbutamol (SABA, selective beta2-adrenergic receptor agonist) 0,1 mg 4-6 puffs 3-4 times every 20 minutes administered by OptiChamber holding chamber. | Drug | After salbutamol |
Primary outcome
Change in modified RDAI
Time frame: Within 3 hours of study entry
RDAI = Respiratory Distress Assessment Instrument, modified to not include auscultation findings. Range 0-18. Higher score indicates more difficult respiratory distress. Evaluated by the blinded panel afterwards using collected videos. Videos collected immediately before and after the intervention.
4 secondary outcomes
Change in saturation of peripheral oxygen
Time frame: Within 3 hours of study entry
Change in auscultation finding
Time frame: Within 3 hours of study entry
Change in the difficulty of the respiratory distress
Time frame: Within 3 hours of study entry
Machine-vision assisted analysis of respiratory status
Time frame: Within 3 hours of study entry
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Terhi Tapiainen, Professor principal investigator
University of Oulu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wheezing, run by University of Oulu at 1 site in Finland.
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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ville Lindholm, MD (+35883155283, Ville.a.lindholm@oulu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in modified RDAI (time frame: Within 3 hours of study entry). 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 13 Feb 2025.