BronchiolitisPhase 2NHSABNCT02760719
The Effectiveness of Nebulized Hypertonic Saline Solution for Acute Bronchiolitis
A Phase 2 study testing nebulized 3% hypertonic solution in people with Bronchiolitis, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
This study evaluates the effectiveness of nebulized 3% hypertonic saline solution with salbutamol in the treatment of children under 2 years, hospitalised for acute viral bronchiolitis. Read more about this study
- Who is it for?
- Ages 1 month to 24 months
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- nebulized 3% hypertonic solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSlovenia
- Study dates
- Dec 2015to Jul 2019
- Phase
- Phase 2
- 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 month to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- first episode of bronchiolitis: viral lower respiratory tract infection with signs of airway obstruction (hyperinflated lungs, tachypnea, increased work of breathing) and crepitations on auscultations
- admission to the hospital
- Wang CSS between 3 and 9
- randomisation within 4 hours of admission
Who cannot join
- a history or previous episodes of bronchiolitis/bronchitis
- primary diseases: gastro-oesophageal reflux, chronic cardiac or pulmonary diseases including suspected asthma, immunodeficiency, conditions with hypotonia where more severe course of bronchiolitis is expected
- newborns
- premature infants born < 36 weeks of gestation
- oxygen saturation < 85% and patients requiring admission to high dependency or intensive care units at presentation
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
Department of infectious disease, University Medical Centre, Ljubljana
Ljubljana, 1000
About this study
Official title: The Effectiveness of Nebulized 3% Hypertonic Saline With Salbutamol in Acute Bronchiolitis in Hospitalised Children- a Randomized Clinical Trial
This study evaluates the effectiveness of nebulized 3% hypertonic saline solution with salbutamol in the treatment of children under 2 years, hospitalised for acute viral bronchiolitis. Half of the participants will receive nebulized 3% hypertonic saline solution with salbutamol three times daily, the other half will receive standard supportive care, which is the cornerstone of the bronchiolitis management.
Read the detailed description
Acute viral bronchiolitis is the most common lower respiratory tract infection in infants up to two years old. Currently there is no effective treatment so standard treatment remains supportive care with supplemental oxygen to correct hypoxia, minimal handling to minimise the risk of exhaustion and the provision of fluids.
In recent years some studies have suggested that nebulised hypertonic saline, which improve airway hygiene, may influence the course of the illness and reduce the duration of hospitalisation without significant side effects.
Study protocol: half of the included patients will receive standard treatment for bronchiolitis, which includes only supportive care, the other half will additionally receive nebulized 3% hypertonic saline solution with salbutamol (to avoid potential bronchial obstruction) three times daily.
- Conditions
- Bronchiolitis
- Being tested
- nebulized 3% hypertonic solution
- Keywords
- 3% hypertonic solution, duration of hospitalisation
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nebulized 3% hypertonic solutionDrug
already described
| Study group | Role | What they receive |
|---|---|---|
| hypertonic saline | Experimental | 4 ml of nebulized 3 % hypertonic saline + salbutamol 0,03 ml/kg every 8 hours for the time of hospitalisation and standard supportive care (oxygen to correct hypoxia, minimal handling to minimise the risk of exhaustion, provision of fluids, gentle nasal aspiration) Receives: Drug: nebulized 3% hypertonic solution |
| supportive care | No intervention | Standard supportive care (oxygen to correct hypoxia, minimal handling to minimise the risk of exhaustion, provision of fluids, gentle nasal aspiration) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fit to discharge time
Fit to discharge time: as the point (measured in hours) at which the infant was feeding adequately (taking >75% of their usual intake) and had been in air with a saturation of at least 92% for 6 h.
Measured: Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years
Secondary outcomes (9)
Duration of hospitalisation
Actual time to discharge in hours, which could be prolonged for other reasons than just bronchiolitis
Measured: Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years
Duration of hypoxia
For how long (in hours) participants need the oxygen therapy (have saturation on air bellow 92%).
Measured: Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years
Clinical severity score (CSS) assessed by Wang score
Wang 1992 CSS as an outcome: measured two times daily
Measured: Through study completion - estimated to 2 years, the patients will be assessed through whole hospitalisation time
Number of participants with treatment related adverse events assessed by questionnaire
To asses all possible side effects related to the inhalation of hypertonic saline
Measured: Through study completion - estimated to 2 years, the patients will be assessed through whole hospitalisation time
Number of participants transferred to the intensive care unit (ICU)
The need to be transferred to the ICU because of the respiratory failure
Measured: Through study completion - estimated to 2 years, the patients will be assessed through whole hospitalisation time
Number of patients readmitted to the hospital because of the same diagnose
Rate of readmission within one month after discharge because of the same disease
Measured: Through study completion - estimated to 2 years; the patients will be assessed up to one month after discharge
Comparison of fit to discharge time between patients treated with nebulized hypertonic saline with respiratory syncytial virus (RSV) versus non-RSV bronchiolitis.
To see if there are any differences in fit to discharge time (the point measured in hours at which the infant was feeding adequately - taking >75% of their usual intake and had been in air with a saturation of at least 92% for 6 h) between patients who received nebulized hypertonic saline and have RSV bronchiolitis and patients who received nebulized hypertonic saline and have non-RSV bronchiolitis (to see if hypertonic saline has better effect on fit to discharge time in patients who have RSV bronchiolitis compared to patients who have non-RSV bronchiolitis).
Measured: Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years
Comparison of hypoxia duration between patients treated with nebulized hypertonic saline with respiratory syncytial virus (RSV) versus non-RSV bronchiolitis.
To see if there are any differences in hypoxia (for how long in hours participants need the oxygen therapy: have saturation bellow 92%) between patients who received nebulized hypertonic saline and have RSV bronchiolitis and patients who received nebulized hypertonic saline and have non-RSV bronchiolitis.
Measured: Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years
Number of participants with treatment related adverse events assessed by questionnaire: comparison of patients with RSV bronchiolitis and patients with non-RSV bronchiolitis.
To asses all possible side effects related to the inhalation of hypertonic saline in patients who have RSV bronchiolitis compared to the patients who have non-RSV bronchiolitis.
Measured: through study completion - estimated to 2 years, the patients will be assessed through whole hospitalisation time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startDec 2015
- Primary completionJul 2019
- Study completionJul 2019
Why it stopped: No relevant data
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 Medical Centre LjubljanaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tina Plankar Srovin, University Medical Centre Ljubljana
- Investigators
- Tatjana Lejko Zupanc, MD, PhD, Study chair, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02760719
- Sponsor's protocol ID
- 22k/12/12
- Acronym
- NHSAB
- Status last verified
- Aug 2019
- First submitted
- 6 Apr 2016
- Last updated
- 5 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Zhang L, Mendoza-Sassi RA, Wainwright C, Klassen TP. Nebulised hypertonic saline solution for acute bronchiolitis in infants. Cochrane Database Syst Rev. 2013 Jul 31;(7):CD006458. doi: 10.1002/14651858.CD006458.pub3.
PubMed 23900970Everard ML, Hind D, Ugonna K, Freeman J, Bradburn M, Cooper CL, Cross E, Maguire C, Cantrill H, Alexander J, McNamara PS; SABRE Study Team. SABRE: a multicentre randomised control trial of nebulised hypertonic saline in infants hospitalised with acute bronchiolitis. Thorax. 2014 Dec;69(12):1105-12. doi: 10.1136/thoraxjnl-2014-205953.
PubMed 25389139Zhang L, Mendoza-Sassi RA, Klassen TP, Wainwright C. Nebulized Hypertonic Saline for Acute Bronchiolitis: A Systematic Review. Pediatrics. 2015 Oct;136(4):687-701. doi: 10.1542/peds.2015-1914.
PubMed 26416925
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Nebulized 3% Hypertonic Saline With Salbutamol in Acute Bronchiolitis in Hospitalised Children- a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02760719
- Acronym / sponsor ID
- NHSAB / 22k/12/12
- Conditions
- Bronchiolitis
- Keywords
- 3% hypertonic solution, duration of hospitalisation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No relevant data
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 4 May 2016 (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.
This study evaluates the effectiveness of nebulized 3% hypertonic saline solution with salbutamol in the treatment of children under 2 years, hospitalised for acute viral bronchiolitis. Half of the participants will receive nebulized 3% hypertonic saline solution with salbutamol three times daily, the other half will receive standard supportive care, which is the cornerstone of the bronchiolitis management.
Detailed description
Acute viral bronchiolitis is the most common lower respiratory tract infection in infants up to two years old. Currently there is no effective treatment so standard treatment remains supportive care with supplemental oxygen to correct hypoxia, minimal handling to minimise the risk of exhaustion and the provision of fluids.
In recent years some studies have suggested that nebulised hypertonic saline, which improve airway hygiene, may influence the course of the illness and reduce the duration of hospitalisation without significant side effects.
Study protocol: half of the included patients will receive standard treatment for bronchiolitis, which includes only supportive care, the other half will additionally receive nebulized 3% hypertonic saline solution with salbutamol (to avoid potential bronchial obstruction) three times daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hypertonic saline | Experimental | Drug: nebulized 3% hypertonic solution4 ml of nebulized 3 % hypertonic saline + salbutamol 0,03 ml/kg every 8 hours for the time of hospitalisation and standard supportive care (oxygen to correct hypoxia, minimal handling to minimise the risk of exhaustion, provision of fluids, gentle nasal aspiration) |
| supportive care | No intervention | –Standard supportive care (oxygen to correct hypoxia, minimal handling to minimise the risk of exhaustion, provision of fluids, gentle nasal aspiration) |
Who may qualify
- Ages
- 1 month to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- first episode of bronchiolitis: viral lower respiratory tract infection with signs of airway obstruction (hyperinflated lungs, tachypnea, increased work of breathing) and crepitations on auscultations
- admission to the hospital
- Wang CSS between 3 and 9
- randomisation within 4 hours of admission
Key exclusion criteria (5 listed)
- a history or previous episodes of bronchiolitis/bronchitis
- primary diseases: gastro-oesophageal reflux, chronic cardiac or pulmonary diseases including suspected asthma, immunodeficiency, conditions with hypotonia where more severe course of bronchiolitis is expected
- newborns
- premature infants born < 36 weeks of gestation
- oxygen saturation < 85% and patients requiring admission to high dependency or intensive care units at presentation
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 |
|---|---|---|
| nebulized 3% hypertonic solutionalready described | Drug | hypertonic saline |
Primary outcome
Fit to discharge time
Time frame: Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years
Fit to discharge time: as the point (measured in hours) at which the infant was feeding adequately (taking >75% of their usual intake) and had been in air with a saturation of at least 92% for 6 h.
9 secondary outcomes
Duration of hospitalisation
Time frame: Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years
Duration of hypoxia
Time frame: Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years
Clinical severity score (CSS) assessed by Wang score
Time frame: Through study completion - estimated to 2 years, the patients will be assessed through whole hospitalisation time
Number of participants with treatment related adverse events assessed by questionnaire
Time frame: Through study completion - estimated to 2 years, the patients will be assessed through whole hospitalisation time
Number of participants transferred to the intensive care unit (ICU)
Time frame: Through study completion - estimated to 2 years, the patients will be assessed through whole hospitalisation time
Number of patients readmitted to the hospital because of the same diagnose
Time frame: Through study completion - estimated to 2 years; the patients will be assessed up to one month after discharge
Comparison of fit to discharge time between patients treated with nebulized hypertonic saline with respiratory syncytial virus (RSV) versus non-RSV bronchiolitis.
Time frame: Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years
Comparison of hypoxia duration between patients treated with nebulized hypertonic saline with respiratory syncytial virus (RSV) versus non-RSV bronchiolitis.
Time frame: Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years
Number of participants with treatment related adverse events assessed by questionnaire: comparison of patients with RSV bronchiolitis and patients with non-RSV bronchiolitis.
Time frame: through study completion - estimated to 2 years, the patients will be assessed through whole hospitalisation time
Results and safety
The study was stopped early (reason given: No relevant data). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
- Results publication: PubMed 23900970Zhang L, Mendoza-Sassi RA, Wainwright C, Klassen TP. Nebulised hypertonic saline solution for acute bronchiolitis in infants. Cochrane Database Syst Rev. 2013 Jul 31;(7):CD006458. doi: 10.1002/14651858.CD006458.pub3.
- Results publication: PubMed 25389139Everard ML, Hind D, Ugonna K, Freeman J, Bradburn M, Cooper CL, Cross E, Maguire C, Cantrill H, Alexander J, McNamara PS; SABRE Study Team. SABRE: a multicentre randomised control trial of nebulised hypertonic saline in infants hospitalised with acute bronchiolitis. Thorax. 2014 Dec;69(12):1105-12. doi: 10.1136/thoraxjnl-2014-205953.
- Results publication: PubMed 26416925Zhang L, Mendoza-Sassi RA, Klassen TP, Wainwright C. Nebulized Hypertonic Saline for Acute Bronchiolitis: A Systematic Review. Pediatrics. 2015 Oct;136(4):687-701. doi: 10.1542/peds.2015-1914.
- 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. This study is not recruiting at the moment.
Tatjana Lejko Zupanc, MD, PhD study chair
University Medical Centre Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing nebulized 3% hypertonic solution in people with Bronchiolitis, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 5 Aug 2019. 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 Slovenia. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: No relevant data). Results are not available in the source record.
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?
Fit to discharge time (time frame: Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years). 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 NCT02760719, which also lists 3 linked publications.
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 5 Aug 2019.