BronchiolitisPhase 4BRONDUSALNCT02538458
Efficacy and Safety of 3% Hypertonic Saline Inhalation (24h vs 72h) to Treat Acute Bronchiolitis in Hospitalized Infants
A Phase 4 study testing 3 % hypertonic saline up to 72H and 3 % hypertonic saline up to 24H in people with Bronchiolitis, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Efficacy/Safety of 3% hypertonic saline inhalation (24H vs 72H) to treat acute bronchiolitis in infants. Read more about this study
- Who is it for?
- Ages 1 minute to 12 months
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- 3 % hypertonic saline up to 72H and 3 % hypertonic saline up to 24H
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2014to Mar 2016
- Phase
- Phase 4
- 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 1 minute to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1st or 2nd episode of acute bronchiolitis, defined by respiratory symptoms episode with initial rhinitis, then cough, then one of the following symptoms : wheezing, crackling, respiratory distress
- Winter epidemic period from November, the 15th, to March the 15th
- Age < 12 months
- Admission Wang score included between 4 and 8
- Infant hospitalized for gravity clinical criteria of severity
- Nebulized 3 % hypertonic saline treatment since less than 24 hours
- Infant with social security card coverage
- Free consent of at least one of the parental authority holder
Who cannot join
- Pulmonary, cardiac or neurologic chronic underlying disease
- Prematurity < 32 GW
- Asthma (3rd episode or more)
- Admission oxygen saturation level < 85 %, Wang score ≥ 9
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Reduction of the Length of Treatment by Nebulized 3% Hypertonic Saline From 72 to 24 Hours on Clinical Remission, in Children Younger Than 12 Month Hospitalized for Acute Bronchiolitis. BRONDUSAL
Efficacy/Safety of 3% hypertonic saline inhalation (24H vs 72H) to treat acute bronchiolitis in infants.
Read the detailed description
In acute bronchiolitis in infants, 3% hypertonic saline nebulizations proved to be efficient, reducing the hospitalization length and clinical severity scores. Among the questions remaining, treatment length is still being discussed in the literature. The trial hypothesis is that the efficiency of a 24 hours treatment by 3% hypertonic saline is not inferior to a 72 hours treatment, in acute bronchiolitis in infants. The primary objective of the study is to compare the efficiency of a 24 hours treatment by 3 % hypertonic saline, versus a 72 hours treatment maximum, on clinical remission, judged by the Wang score measured 72 hours after starting treatment, in children younger than 12 month hospitalized for acute bronchiolitis.
- Conditions
- Bronchiolitis
- Being tested
- 3 % hypertonic saline up to 72H, 3 % hypertonic saline up to 24H
- Keywords
- Saline Solution, Hypertonic (3 %), Infant
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 % hypertonic saline up to 72HDrug
Also called 3 % hypertonic saline
Treatment by inhalation of 3 % hypertonic saline, up to 72H. Test group.
3 % hypertonic saline up to 24HDrug
Also called palcebo
- Treatment by inhalation of 3 % hypertonic saline, up to 24H.
- followed by 48h of placebo : isotonic saline inhalation. Placebo control group.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Active comparator | 3 % hypertonic saline up to 72H. Receives: Drug: 3 % hypertonic saline up to 72H |
| Placebo control group | Placebo comparator | * 3 % hypertonic saline up to 24H.
* Followed by 48 hours of placebo (nebulized 0.9% normal saline). Receives: Drug: 3 % hypertonic saline up to 24H |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wang score after 72 hours of treatment
Measured: 72 hours
Secondary outcomes (6)
Recovery time
Secondary outcomes will be assessed during the hospital stay for acute bronchiolitis, from inclusion date until day of hospital discharge, within 2 weeks.
Measured: From Day 1 to end of the hospitalisation within 2 weeks, assessed at EOS (End of study for the patient, meaning discharge from hospital)
To determine percentage of patient needing transfer to the PICU or use of mechanical ventilation
Percentage of patient needing transfer to the PICU or use of mechanical ventilation
Measured: From Day 1 to end of the hospitalisation, assessed at EOS (End of study for the patient, meaning discharge from hospital)
To assess average time of Oxygen therapy
average time of Oxygen therapy in days
Measured: From Day 1 to end of the hospitalisation, assessed at EOS (End of study for the patient, meaning discharge from hospital)
To assess average time of Tube feeding
average time of Tube feeding in days.
Measured: From Day 1 to end of the hospitalisation, assessed at EOS (End of study for the patient, meaning discharge from hospital)
To determine variation of Wang score during hospitalisation
Wang score,
Measured: measured at Day 1, 2, 3, 4 and day of discharge.
To determine percentage of patient with Adverse Event
percentage of patient with Adverse Event
Measured: From Day 1 to end of the hospitalisation, assessed at EOS (End of study for the patient, meaning discharge from hospital)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study startNov 2014
- Primary completionMar 2016
- Study completionMar 2016
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 BronchiolitisStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- AGIR à Dom
- Responsible party
- Sponsor
- Investigators
- Catherine BARBIER, PHD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02538458
- Sponsor's protocol ID
- 2014-A01335-42
- Acronym
- BRONDUSAL
- Status last verified
- Nov 2017
- First submitted
- 5 Aug 2015
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Beal G, Barbier C, Thoret S, Rubio A, Bonnet M, Mazet R, Ego A, Pin I. Nebulized hypertonic saline 3% for 1 versus 3 days in hospitalized bronchiolitis: a blinded non-inferiority randomized controlled trial. BMC Pediatr. 2019 Nov 8;19(1):417. doi: 10.1186/s12887-019-1804-0.
PubMed 31699072
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Reduction of the Length of Treatment by Nebulized 3% Hypertonic Saline From 72 to 24 Hours on Clinical Remission, in Children Younger Than 12 Month Hospitalized for Acute Bronchiolitis. BRONDUSAL
- ClinicalTrials.gov ID
- NCT02538458
- Acronym / sponsor ID
- BRONDUSAL / 2014-A01335-42
- Conditions
- Bronchiolitis
- Keywords
- Saline Solution, Hypertonic (3 %), Infant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- AGIR à Dom
- Study start
- Nov 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 2 Sep 2015 (estimated)
- 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.
Efficacy/Safety of 3% hypertonic saline inhalation (24H vs 72H) to treat acute bronchiolitis in infants.
Detailed description
In acute bronchiolitis in infants, 3% hypertonic saline nebulizations proved to be efficient, reducing the hospitalization length and clinical severity scores. Among the questions remaining, treatment length is still being discussed in the literature. The trial hypothesis is that the efficiency of a 24 hours treatment by 3% hypertonic saline is not inferior to a 72 hours treatment, in acute bronchiolitis in infants. The primary objective of the study is to compare the efficiency of a 24 hours treatment by 3 % hypertonic saline, versus a 72 hours treatment maximum, on clinical remission, judged by the Wang score measured 72 hours after starting treatment, in children younger than 12 month hospitalized for acute bronchiolitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Active comparator | Drug: 3 % hypertonic saline up to 72H3 % hypertonic saline up to 72H. |
| Placebo control group | Placebo comparator | Drug: 3 % hypertonic saline up to 24H* 3 % hypertonic saline up to 24H. * Followed by 48 hours of placebo (nebulized 0.9% normal saline). |
Who may qualify
- Ages
- 1 minute to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 1st or 2nd episode of acute bronchiolitis, defined by respiratory symptoms episode with initial rhinitis, then cough, then one of the following symptoms : wheezing, crackling, respiratory distress
- Winter epidemic period from November, the 15th, to March the 15th
- Age < 12 months
- Admission Wang score included between 4 and 8
- Infant hospitalized for gravity clinical criteria of severity
Key exclusion criteria (4 listed)
- Pulmonary, cardiac or neurologic chronic underlying disease
- Prematurity < 32 GW
- Asthma (3rd episode or more)
- Admission oxygen saturation level < 85 %, Wang score ≥ 9
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 |
|---|---|---|
| 3 % hypertonic saline up to 72HAlso: 3 % hypertonic salineTreatment by inhalation of 3 % hypertonic saline, up to 72H. Test group. | Drug | Test group |
| 3 % hypertonic saline up to 24HAlso: palcebo* Treatment by inhalation of 3 % hypertonic saline, up to 24H. * followed by 48h of placebo : isotonic saline inhalation. Placebo control group. | Drug | Placebo control group |
Primary outcome
Wang score after 72 hours of treatment
Time frame: 72 hours
6 secondary outcomes
Recovery time
Time frame: From Day 1 to end of the hospitalisation within 2 weeks, assessed at EOS (End of study for the patient, meaning discharge from hospital)
To determine percentage of patient needing transfer to the PICU or use of mechanical ventilation
Time frame: From Day 1 to end of the hospitalisation, assessed at EOS (End of study for the patient, meaning discharge from hospital)
To assess average time of Oxygen therapy
Time frame: From Day 1 to end of the hospitalisation, assessed at EOS (End of study for the patient, meaning discharge from hospital)
To assess average time of Tube feeding
Time frame: From Day 1 to end of the hospitalisation, assessed at EOS (End of study for the patient, meaning discharge from hospital)
To determine variation of Wang score during hospitalisation
Time frame: measured at Day 1, 2, 3, 4 and day of discharge.
To determine percentage of patient with Adverse Event
Time frame: From Day 1 to end of the hospitalisation, assessed at EOS (End of study for the patient, meaning discharge from hospital)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Derived from this study: PubMed 31699072Beal G, Barbier C, Thoret S, Rubio A, Bonnet M, Mazet R, Ego A, Pin I. Nebulized hypertonic saline 3% for 1 versus 3 days in hospitalized bronchiolitis: a blinded non-inferiority randomized controlled trial. BMC Pediatr. 2019 Nov 8;19(1):417. doi: 10.1186/s12887-019-1804-0.
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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.
Catherine BARBIER, PHD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 3 % hypertonic saline up to 72H and 3 % hypertonic saline up to 24H in people with Bronchiolitis, run by University Hospital, Grenoble at 1 site 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 8 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: finished, as of the sponsor's last update on 6 Nov 2017. 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 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wang score after 72 hours of treatment (time frame: 72 hours). 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 NCT02538458, 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 6 Nov 2017.