Bronchiolitis AcuteB-CLASSNCT06177197
Bronchiolitis Clearance Airways With Seaserum
A study testing Physiomer and Saline solution in people with Bronchiolitis Acute, run by University Hospital, Brest at 8 sites in France.
Trial summary
The objective of this study is to show that the use of electrodialyzed seawater reduces the duration (in days) of symptoms in acute infant bronchiolitis compared with the use of saline solution in infants aged 1 month to less than one year. Read more about this study
- Who is it for?
- Ages 1 month to 1 year
- Conditions the study is for
- Bronchiolitis Acute
- What is being tested?
- Physiomer and Saline solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 458 participants
- Where
- 8 sitesFrance
- Study dates
- 10 Jan 2025to 1 Dec 2028
- 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 1 month to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants aged more than 1 month and less than 1 year
- First episode of acute bronchiolitis
- Emergency consultation
- Existence of nasal obstruction
- Onset of symptoms \< 48 hours before emergency consultation
- Outpatient care after emergency consultation
Show all 10Show fewer
- Mild to moderate bronchiolitis according to the \"Haute Autorité de Santé 2019\" criteria:
- Respiratory rate over 1 minute \>30/minutes and \<60/minute ; Heart rate \>80/minutes and \<180/minutes; Absence of respiratory pauses; Absence of superficial breathing; Absence of signs of intense respiratory struggle: involvement of the lower intercostal accessory muscles, sternocleidomastoid muscles, thoracoabdominal swinging, or flapping of the wings of the nose; Feeding \>50% of the usual quantity over 3 consecutive doses; SpO2 \> 92% during sleep ; \>94% when awake; \>2 months corrected age
- Parental consent
- Affiliate to a social security system
Who cannot join
- Hospitalization (excluding short stay unit) after emergency consultation
- Oxygen therapy
- History of prematurity (birth \<36 weeks of amenorrhea)
- History of invasive ventilation in the neonatal period
- History of chronic pulmonary or cardiac pathology
- History of immune deficiency
Show all 9Show fewer
- History of polyhandicap or neuromuscular pathology
- History of malformative Ear Nose and Throat pathology affecting the upper airways
- Impossibility of ensuring the follow-up made necessary by participation in this study
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Léa GAITAN, MD contact
8 sites in 1 country
France8 sites, 8 recruiting
- Recruiting
Brest, University Hospital
Brest, 29609
Pierrick CROS, MD, 02 98 22 36 59, pierrick.cros@chu-brest.fr
Guillaume DEVERRIERE, MD, guillaume.deverriere@chu-brest.fr
- Recruiting
Le Mans hospital
Le Mans, 72037
Aude FORGERON, MD
- Not yet recruiting
Lille, University hospital
Lille, 59000
François DUBOS, MD
- Recruiting
Saint-Joseph hospital
Marseille, 13008
Ania CARSIN, MD
- Recruiting
Morlaix hospital
Morlaix, 29600
Thomas BRIAND, MD
- Recruiting
Nantes, University Hospital
Nantes, 44400
Anne-Claire VIGUIE, MD
- Recruiting
Rennes, University hospital
Rennes, 35033
Tommasco DE GIORGIS, MD
- Recruiting
Tours, University hospital
Tours, 37000
Yves MAROT, MD
About this study
Official title: Bronchiolitis Clearance Airways With Seaserum : a Doubled Blind Randomized Study
The objective of this study is to show that the use of electrodialyzed seawater reduces the duration (in days) of symptoms in acute infant bronchiolitis compared with the use of saline solution in infants aged 1 month to less than one year.
B-CLASS study is a multicenter, prospective, controlled, randomized, double label blind.
Read the detailed description
This is a multicenter, prospective, controlled, randomized in 2 parrallel arms, double blind study. The Infants will be included after written informed consent will be obtained from the patients' parents or legally authorized representatives. Patients will be randomized either in the experimental group (electrodialyzed seawater) or in the control group (saline solution).
Patients' parents will be call by phone at day 1, day 3, day 6, day 10 and day 21 after baseline.
- Conditions
- Bronchiolitis Acute
- Being tested
- Physiomer, Saline solution
- Keywords
- Infant, Nasopharyngeal decongestion, Bronchiolitis
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiomerDevice
Also called Electrodilysed seawater solution
Infants randomized to the experimental group will be given an electrolyzed seawater solution by their parents for up to 10 days. Dosage is adapted according to the child's age and discomfort:
- Infant < 6 months: half a dose to a single dose administered per nostril 8 times a day.
- Infant > 6 months: one single dose administered per nostril 6 times a day.
Saline solutionDevice
Infants randomized to the control group will be given a saline solution by their parents for up to 10 days. Dosage is adapted according to the child's age and discomfort:
- Infant < 6 months: half a dose to a single dose administered per nostril 8 times a day.
- Infant > 6 months: one single dose administered per nostril 6 times a day.
| Study group | Role | What they receive |
|---|---|---|
| Physiomer | Experimental | It is a sterile, isotonic seawater-based solution, with a concentration equivalent to 9 g/L sodium chloride. This solution is packaged in 5 mL single-dose units.
It is a Class IIa medical device manufactured by Laboratoire de la mer, and is CE marked.
Electrodialyzed seawater solution is administered via the nasal passage, in line with current recommendations. Dosage varies according to age, and the pressure exerted on the unit dose enables the product to be administered into the nostril. Receives: Device: Physiomer |
| Saline solution | Active comparator | It is a sterile, isotonic seawater-based solution, with a concentration egal to 0,9 g/L sodium chloride. This solution is packaged in 5 mL single-dose units.
It is a Class IIa medical device manufactured by GiLBERT, and is CE marked. The saline solution is administered via the nasal passage, in line with current recommendations. Dosage varies according to age, and the pressure exerted on the unit dose enables the product to be administered into the nostril. Receives: Device: Saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of resolution of illness (ROI)
It is the time it takes for the child to return to baseline according to the person administering the care.
ROI is defined by ordinal scale from 0 to 4 on which parents globally rate symptoms according to the following categories: (1) worsened, (2) same, (3) improved, (4) resolved. The duration of ROI is the time it takes to obtain a score of 4.
Measured: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10
Secondary outcomes (14)
An again medical consultation
Parents will be given a notebook to fill in on a daily basis. For this outcome, the following question will be asked: "Have you seen a doctor today for bronchiolitis?" YES/NO
Measured: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10
Hospitalization
Parents will be given a notebook to fill in on a daily basis. For this outcome, the following question will be asked: "Is your child in hospital?" YES/NO. If yes, the length of hospital stay in hours will be collected.
Measured: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10
Time to improvement of cough in days
Parents will be given a notebook to fill in on a daily basis. For this outcome, the following question will be asked: "How is the cough today?", with four possible answers (1) worsened, (2) same, (3) improved, (4) resolved.
Measured: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10
Time to improvement of nasal congestion in days
Parents will be given a notebook to fill in on a daily basis. For this outcome, the following question will be asked: "How are colds today??", with four possible answers (1) worsened, (2) same, (3) improved, (4) resolved.
Measured: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10
Length with nasopharyngeal decongestion in days
Parents will be given a notebook to fill in on a daily basis. For this outcome, the following question will be asked: "How many nasopharyngeal decongestion did you make today?". The duration of nasopharyngeal decongestion is the time it takes to obtain a score of 0.
Measured: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10
Number of nasopharyngeal decongestion by day
Parents will be given a notebook to fill in on a daily basis. For this outcome, the following question will be asked: "How many nasopharyngeal decongestion did you make today?".
Measured: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10
Length of dietary resumption greater than 2/3 of usual intake.
Parents will be given a notebook to fill in on a daily basis. For this outcome, the following question will be asked: "How does your child eat today?". Two responses are possible : More than two-thirds, less than two-thirds.
The duration of dietary resumption greater than 2/3 of usual intake is the number of days until the response is "More than half".
Measured: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10
Antibiotic use
Parents will be given a notebook to fill in on a daily basis. For this outcome, the following question will be asked: "Is your child taking antibiotics?". YES/NO
Measured: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10
Length of community eviction en days
Parents will be given a notebook to fill in on a daily basis. For this outcome, the following question will be asked: "Did your child have to be looked after today?". YES/NO. The duration of community eviction is the time to the child doesn't need to be looked after anymore.
Measured: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10
Length of parental absence from work (in days)
Parents will be given a notebook to fill in on a daily basis. For this outcome, the following question will be asked: "Did you have to miss work today?". YES/NO. The duration of parental absence is the number of day until that parent returns to work.
Measured: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10
Occurrence of secondary events: epistaxis, vomiting, malaise, apnea
Parents will be given a notebook to fill in on a daily basis. For this outcome, the following question will be asked: "Have you noticed any side effects from nasopharyngeal decongestion?". YES/NO.
Measured: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10
Time to improvement in respiratory discomfort in days
Parents will be given a notebook to fill in on a daily basis. For this outcome, the following question will be asked: "Is your child suffering from respiratory problems today?", with four possible answers (1) worsened, (2) same, (3) improved, (4) resolved.
Measured: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10
Time to improvement in sleep quality in days
Parents will be given a notebook to fill in on a daily basis. For this outcome, the following question will be asked: "How do you rate the quality of your child's sleep?", with four possible answers (1) worsened, (2) same, (3) improved, (4) resolved.
Measured: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10
Decrease of number of acute middle ear
Number of patients with an acute middle ear
Measured: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start10 Jan 2025
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchiolitis AcuteStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- multicenter, prospective, controlled, randomized in two parallel arms, double label blind.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 458 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06177197
- Sponsor's protocol ID
- 29BRC23.0193
- Acronym
- B-CLASS
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2023
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bronchiolitis Clearance Airways With Seaserum : a Doubled Blind Randomized Study
- ClinicalTrials.gov ID
- NCT06177197
- Acronym / sponsor ID
- B-CLASS / 29BRC23.0193
- Conditions
- Bronchiolitis Acute
- Keywords
- Infant, Nasopharyngeal decongestion, Bronchiolitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 458 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 20 Dec 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 objective of this study is to show that the use of electrodialyzed seawater reduces the duration (in days) of symptoms in acute infant bronchiolitis compared with the use of saline solution in infants aged 1 month to less than one year.
B-CLASS study is a multicenter, prospective, controlled, randomized, double label blind.
Detailed description
This is a multicenter, prospective, controlled, randomized in 2 parrallel arms, double blind study. The Infants will be included after written informed consent will be obtained from the patients' parents or legally authorized representatives. Patients will be randomized either in the experimental group (electrodialyzed seawater) or in the control group (saline solution).
Patients' parents will be call by phone at day 1, day 3, day 6, day 10 and day 21 after baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- multicenter, prospective, controlled, randomized in two parallel arms, double label blind.
| Arm | Type | Receives |
|---|---|---|
| Physiomer | Experimental | Device: PhysiomerIt is a sterile, isotonic seawater-based solution, with a concentration equivalent to 9 g/L sodium chloride. This solution is packaged in 5 mL single-dose units. It is a Class IIa medical device manufactured by Laboratoire de la mer, and is CE marked. Electrodialyzed seawater solution is administered via the nasal passage, in line with current recommendations. Dosage varies according to age, and the pressure exerted on the unit dose enables the product to be administered into the nostril. |
| Saline solution | Active comparator | Device: Saline solutionIt is a sterile, isotonic seawater-based solution, with a concentration egal to 0,9 g/L sodium chloride. This solution is packaged in 5 mL single-dose units. It is a Class IIa medical device manufactured by GiLBERT, and is CE marked. The saline solution is administered via the nasal passage, in line with current recommendations. Dosage varies according to age, and the pressure exerted on the unit dose enables the product to be administered into the nostril. |
Who may qualify
- Ages
- 1 month to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Infants aged more than 1 month and less than 1 year
- First episode of acute bronchiolitis
- Emergency consultation
- Existence of nasal obstruction
- Onset of symptoms \&lt; 48 hours before emergency consultation
Key exclusion criteria (9 listed)
- Hospitalization (excluding short stay unit) after emergency consultation
- Oxygen therapy
- History of prematurity (birth \<36 weeks of amenorrhea)
- History of invasive ventilation in the neonatal period
- History of chronic pulmonary or cardiac pathology
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 |
|---|---|---|
| PhysiomerAlso: Electrodilysed seawater solutionInfants randomized to the experimental group will be given an electrolyzed seawater solution by their parents for up to 10 days. Dosage is adapted according to the child's age and discomfort: * Infant < 6 months: half a dose to a single dose administered per nostril 8 times a day. * Infant > 6 months: one single dose administered per nostril 6 times a day. | Device | Physiomer |
| Saline solutionInfants randomized to the control group will be given a saline solution by their parents for up to 10 days. Dosage is adapted according to the child's age and discomfort: * Infant < 6 months: half a dose to a single dose administered per nostril 8 times a day. * Infant > 6 months: one single dose administered per nostril 6 times a day. | Device | Saline solution |
Primary outcome
Duration of resolution of illness (ROI)
Time frame: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10
It is the time it takes for the child to return to baseline according to the person administering the care. ROI is defined by ordinal scale from 0 to 4 on which parents globally rate symptoms according to the following categories: (1) worsened, (2) same, (3) improved, (4) resolved. The duration of ROI is the time it takes to obtain a score of 4.
14 secondary outcomes
An again medical consultation
Time frame: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10
Hospitalization
Time frame: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10
Time to improvement of cough in days
Time frame: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10
Time to improvement of nasal congestion in days
Time frame: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10
Length with nasopharyngeal decongestion in days
Time frame: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10
Number of nasopharyngeal decongestion by day
Time frame: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10
Length of dietary resumption greater than 2/3 of usual intake.
Time frame: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10
Antibiotic use
Time frame: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10
Length of community eviction en days
Time frame: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10
Length of parental absence from work (in days)
Time frame: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10
Occurrence of secondary events: epistaxis, vomiting, malaise, apnea
Time frame: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10
Time to improvement in respiratory discomfort in days
Time frame: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10
Time to improvement in sleep quality in days
Time frame: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10
Decrease of number of acute middle ear
Time frame: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10
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 17 Dec 2025.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
Léa GAITAN, MD contact
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiomer and Saline solution in people with Bronchiolitis Acute, run by University Hospital, Brest at 8 sites in France.
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 10 inclusion and 9 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 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. 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 Pierrick CROS, MD (+33298223659, pierrick.cros@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of resolution of illness (ROI) (time frame: At day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10). 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 17 Dec 2025; AzTrials last refreshed its copy on 26 Oct 2026.