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Not yet recruitingNCT06689631CLEARBRONCHUpdated Nov 19, 2024

Mucociliary Clearance Techniques for Acute Bronchiolitis

An interventional study of Respiratory Physiotherapy in Acute Bronchiolitis Due to Respiratory Syncytial Virus, Bronchiolitis Acute and Bronchiolitis Acute Viral, sponsored by Universidad de León. Not yet recruiting. Open to participants aged 28 Days to 12 Months. Per ClinicalTrials.gov, last updated 2024-11-19.

Sponsored by Universidad de León · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 5 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Not applicable
Ages
28 Days to 12 Months
Sex
All
01

Study summary

To assess the efficacy of mucociliary clearance techniques in non-hospitalised infants with a first episode of mild to moderate acute bronchiolitis.

02

Conditions studied

  • Acute Bronchiolitis Due to Respiratory Syncytial Virus
  • Bronchiolitis Acute
  • Bronchiolitis Acute Viral

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Keywords

  • mucociliary clearance
  • respiratory physiotherapy
03

In context

Bronchiolitis

289 studies on the registry are indexed under Bronchiolitis; 51 are open to participants now.

This study's planned enrollment of 70 is below the median of 100 across 195 interventional studies indexed under Bronchiolitis.

Browse Bronchiolitis studies →

Lead sponsor

Universidad de León is the lead sponsor of 26 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
28 Days to 12 Months
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • 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.
  • signed by parents or legal guardians.

Exclusion criteria

Exclusion Criteria:

  • Infants previously diagnosed with chronic respiratory disease.
  • Previous episodes of wheezing.
  • Presence of any type of to receive Respiratory Physiotherapy treatment.
Terms in these criteria, in plain language(2)

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.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Treatment group

    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.

    Procedure: Respiratory Physiotherapy

Interventions

  • ProcedureRespiratory Physiotherapy

    Mucociliary clearance techniques (prolonged slow expiration and provoked cough), bronchodilator when prescribed and nebulisation with 3% hypertonic saline.

06

What researchers measure

Primary outcomes

  1. ESBA

    The variables collected using the ESBA scale were: wheezing, crackles, inspiratory effort, Inspiratory/Expiratory ratio, respiratory rate and heart rate.

    Time frame: 1 session (45 minutes)

07

Study locations

No study locations are listed for this record.

08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06689631
Lead sponsor
Universidad de León
Responsible party
Raquel Leirós-Rodríguez (Principal investigator and Associate Professor, Universidad de León) — Principal investigator
First posted
Nov 14, 2024
Start date
Dec 1, 2024 (estimated)
Primary completion
May 31, 2025 (estimated)
Completion
May 31, 2025 (estimated)
Last update
Nov 19, 2024

Study contacts

Raquel Leirós-Rodríguez, PhD.
Contact
rleir@unileon.es
+34 987 44 20 00

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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