Acute Bronchiolitis Due to Respiratory Syncytial VirusCLEARBRONCHNCT06689631
Mucociliary Clearance Techniques for Acute Bronchiolitis
A study testing Respiratory Physiotherapy in people with Acute Bronchiolitis Due to Respiratory Syncytial Virus and Bronchiolitis Acute, run by Universidad de León.
Trial summary
To assess the efficacy of mucociliary clearance techniques in non-hospitalised infants with a first episode of mild to moderate acute bronchiolitis. Read more about this study
- Who is it for?
- Ages 28 days to 12 months
- Conditions the study is for
- Acute Bronchiolitis Due to Respiratory Syncytial Virus, Bronchiolitis Acute, Bronchiolitis Acute Viral
- What is being tested?
- Respiratory Physiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 31 May 2025
- Phase
- Interventional
- 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 28 days to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Medical diagnosis of first episode of acute Bronchiolitis.
- Acute Bronchiolitis with mild (ESBA score = 1-4) or moderate (ESBA score =5-9) severity according to the ESBA.
- Informed consent signed by parents or legal guardians.
Who cannot join
- Infants previously diagnosed with chronic respiratory disease.
- Previous episodes of wheezing.
- Presence of any type of contraindication to receive Respiratory Physiotherapy treatment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy of Mucociliary Clearance Techniques in Non-hospitalised Infants with Acute Bronchiolitis
To assess the efficacy of mucociliary clearance techniques in non-hospitalised infants with a first episode of mild to moderate acute bronchiolitis.
- Conditions
- Acute Bronchiolitis Due to Respiratory Syncytial Virus, Bronchiolitis Acute, Bronchiolitis Acute Viral
- Being tested
- Respiratory Physiotherapy
- Keywords
- mucociliary clearance, respiratory physiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory PhysiotherapyProcedure or surgery
Mucociliary clearance techniques (prolonged slow expiration and provoked cough), bronchodilator when prescribed and nebulisation with 3% hypertonic saline.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | The intervention consisted of a Respiratory Physiotherapy session including: mucociliary clearance techniques (prolonged slow expiration and provoked cough), bronchodilator when prescribed and nebulisation with 3% hypertonic saline. Receives: Procedure: Respiratory Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
ESBA
The variables collected using the ESBA scale were: wheezing, crackles, inspiratory effort, Inspiratory/Expiratory ratio, respiratory rate and heart rate.
Measured: 1 session (45 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Bronchiolitis Due to Respiratory Syncytial VirusStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de León
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raquel Leirós-Rodríguez, Universidad de León
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06689631
- Sponsor's protocol ID
- ETICA-ULE-062-2023
- Other IDs
- ULE
- Acronym
- CLEARBRONCH
- Status last verified
- Nov 2024
- First submitted
- 13 Nov 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gonzalez Bellido V, Velaz Baza V, Esteo MDCJ, Carballo RG, Colombo A, Zaldivar JNC, Donadio MVF. Safety of airway clearance combined with bronchodilator and hypertonic saline in non-hospitalized infants with acute bronchiolitis. Arch Pediatr. 2021 Nov;28(8):707-711. doi: 10.1016/j.arcped.2021.09.007. Epub 2021 Oct 5.
PubMed 34625378
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Mucociliary Clearance Techniques in Non-hospitalised Infants with Acute Bronchiolitis
- ClinicalTrials.gov ID
- NCT06689631
- Acronym / sponsor ID
- CLEARBRONCH / ETICA-ULE-062-2023
- Conditions
- Acute Bronchiolitis Due to Respiratory Syncytial Virus, Bronchiolitis Acute, Bronchiolitis Acute Viral
- Keywords
- mucociliary clearance, respiratory physiotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Universidad de LeónUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 14 Nov 2024 (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.
To assess the efficacy of mucociliary clearance techniques in non-hospitalised infants with a first episode of mild to moderate acute bronchiolitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Procedure: Respiratory PhysiotherapyThe intervention consisted of a Respiratory Physiotherapy session including: mucociliary clearance techniques (prolonged slow expiration and provoked cough), bronchodilator when prescribed and nebulisation with 3% hypertonic saline. |
Who may qualify
- Ages
- 28 days to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Medical diagnosis of first episode of acute Bronchiolitis.
- Acute Bronchiolitis with mild (ESBA score = 1-4) or moderate (ESBA score =5-9) severity according to the ESBA.
- Informed consent signed by parents or legal guardians.
Key exclusion criteria (3 listed)
- Infants previously diagnosed with chronic respiratory disease.
- Previous episodes of wheezing.
- Presence of any type of contraindication to receive Respiratory Physiotherapy treatment.
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 |
|---|---|---|
| Respiratory PhysiotherapyMucociliary clearance techniques (prolonged slow expiration and provoked cough), bronchodilator when prescribed and nebulisation with 3% hypertonic saline. | Procedure or surgery | Treatment group |
Primary outcome
ESBA
Time frame: 1 session (45 minutes)
The variables collected using the ESBA scale were: wheezing, crackles, inspiratory effort, Inspiratory/Expiratory ratio, respiratory rate and heart rate.
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 19 Nov 2024.
- Background: PubMed 34625378Gonzalez Bellido V, Velaz Baza V, Esteo MDCJ, Carballo RG, Colombo A, Zaldivar JNC, Donadio MVF. Safety of airway clearance combined with bronchodilator and hypertonic saline in non-hospitalized infants with acute bronchiolitis. Arch Pediatr. 2021 Nov;28(8):707-711. doi: 10.1016/j.arcped.2021.09.007. Epub 2021 Oct 5.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory Physiotherapy in people with Acute Bronchiolitis Due to Respiratory Syncytial Virus and Bronchiolitis Acute, run by Universidad de León.
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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 19 Nov 2024. 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. 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 Raquel Leirós-Rodríguez, PhD. (+34 987 44 20 00, rleir@unileon.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ESBA (time frame: 1 session (45 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06689631, which also lists 1 linked publication.
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 19 Nov 2024.