Moderate to Severe BronchiolitisPhase 3NCT01812525
Moderate to Severe Bronchiolitis: Standard Therapy Versus Therapy With NaCl 3% Inhalations
A Phase 3 study testing NaCl 3% and Standard therapy in people with Moderate to Severe Bronchiolitis, run by Raphaelle Jaquet-Pilloud at 1 site in Switzerland.
Trial summary
Our study will investigate inhalation therapy of NaCl 3% compared to standard therapy with no inhalation in the treatment of moderate to severe bronchiolitis. The impact on length of hospital stay will be analyzed. Read more about this study
- Who is it for?
- Ages 6 weeks to 24 months
- Conditions the study is for
- Moderate to Severe Bronchiolitis
- What is being tested?
- NaCl 3% and Standard therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2013to Apr 2016
- Phase
- Phase 3
- 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 6 weeks to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children between ages 6 weeks to 24 months
- first episode of wheezing
- diagnosis of moderate to severe bronchiolitis: The patients are ranked as moderately to severely ill according to the Wang clinical severity score
Who cannot join
- Children with mild bronchiolitis (Wang score < 5)
- Children with pre-existent cardiac disease
- Children with clinically significant chronic respiratory disease
- Immunocompromised children
- Children with a gestational age at birth less than 34 weeks
- Children who received immunoprophylaxis therapy (i.e RSV immune globulin therapy)
Show all 9Show fewer
- Children who received corticosteroid in any form in the preceding 2 weeks before presentation
- Children who received bronchodilators within 24 hours before presentation
- Children with critical illness at presentation requiring immediate admission to intensive care unit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Moderate to Severe Bronchiolitis: Standard Therapy Versus Therapy With NaCl 3%
Our study will investigate inhalation therapy of NaCl 3% compared to standard therapy with no inhalation in the treatment of moderate to severe bronchiolitis. The impact on length of hospital stay will be analyzed.
Read the detailed description
Acute viral bronchiolitis is the most common lower respiratory tract infection in the first year of life and leads to a large number of hospital admissions. The only recommended treatment is supportive. However many different types of drug inhalations have been studied but their efficacy remains controversial.
Our study will compare recommended supportive therapy to supportive therapy combined to hypertonic saline (NaCl 3%) inhalations in the treatment of moderate to severe bronchiolitis. This will be the first study to use a true control group with no inhalation.
- Conditions
- Moderate to Severe Bronchiolitis
- Being tested
- NaCl 3%, Standard therapy
- Keywords
- Bronchiolitis, Moderate to Severe, Hypertonic saline, NaCl 3% inhalations, Standard therapy, Wang score, in-patients
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaCl 3%Drug
Also called Mucoclear 3%
NaCl 3%: 4ml QID
Standard therapyOther
Standard therapy includes suctioning nasal secretions, water-electrolyte balance maintenance and oxygen supplementation when needed
| Study group | Role | What they receive |
|---|---|---|
| NaCl 3% inhalations + standard therapy | Active comparator | In this group, patients receive NaCl 3% inhalations ( 4ml QID) together with standard therapy.
Standard therapy includes suctioning nasal secretions, water-electrolyte balance maintenance and oxygen supplementation when needed. Receives: Drug: NaCl 3%; Other: Standard therapy |
| Standard therapy | Placebo comparator | Standard therapy includes suctioning nasal secretions, water-electrolyte balance maintenance and oxygen supplementation when needed Receives: Other: Standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of hospital stay
The length of stay is defined as the time between study entry and the time at which the child reach protocol-defined discharge criteria as measured by the physician in charge.
Measured: 2 years
Secondary outcomes (5)
transfer rate to ICU
Measured: 2 years
readmission rate in the next 7 days following discharge
Measured: 2 years
Wang clinical severity score evolution
Measured: 2 years
adverse events
Measured: 2 years
Patients' ability to feed
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionApr 2016
- Study completionApr 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 Moderate to Severe BronchiolitisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Raphaelle Jaquet-Pilloud
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Foundation for the Health of Children and Adolescents
- Responsible party
- Sponsor-investigator, Raphaelle Jaquet-Pilloud, Hôpital de L'Enfance
- Investigators
- Jean-Yves Pauchard, Study director, Hôpital de l'Enfance, Lausanne, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01812525
- Sponsor's protocol ID
- 453/12
- Status last verified
- Aug 2016
- First submitted
- 14 Mar 2013
- Last updated
- 19 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jaquet-Pilloud R, Verga ME, Russo M, Gehri M, Pauchard JY. Nebulised hypertonic saline in moderate-to-severe bronchiolitis: a randomised clinical trial. Arch Dis Child. 2020 Mar;105(3):236-240. doi: 10.1136/archdischild-2019-317160. Epub 2019 Sep 5.
PubMed 31488402
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moderate to Severe Bronchiolitis: Standard Therapy Versus Therapy With NaCl 3%
- ClinicalTrials.gov ID
- NCT01812525
- Acronym / sponsor ID
- 453/12
- Conditions
- Moderate to Severe Bronchiolitis
- Keywords
- Bronchiolitis, Moderate to Severe, Hypertonic saline, NaCl 3% inhalations, Standard therapy, Wang score, in-patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Raphaelle Jaquet-PilloudUniversity, hospital or other
- Collaborators
- Swiss Foundation for the Health of Children and Adolescents
- Study start
- Mar 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 18 Mar 2013 (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.
Our study will investigate inhalation therapy of NaCl 3% compared to standard therapy with no inhalation in the treatment of moderate to severe bronchiolitis. The impact on length of hospital stay will be analyzed.
Detailed description
Acute viral bronchiolitis is the most common lower respiratory tract infection in the first year of life and leads to a large number of hospital admissions. The only recommended treatment is supportive. However many different types of drug inhalations have been studied but their efficacy remains controversial.
Our study will compare recommended supportive therapy to supportive therapy combined to hypertonic saline (NaCl 3%) inhalations in the treatment of moderate to severe bronchiolitis. This will be the first study to use a true control group with no inhalation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NaCl 3% inhalations + standard therapy | Active comparator | Drug: NaCl 3%, Other: Standard therapyIn this group, patients receive NaCl 3% inhalations ( 4ml QID) together with standard therapy. Standard therapy includes suctioning nasal secretions, water-electrolyte balance maintenance and oxygen supplementation when needed. |
| Standard therapy | Placebo comparator | Other: Standard therapyStandard therapy includes suctioning nasal secretions, water-electrolyte balance maintenance and oxygen supplementation when needed |
Who may qualify
- Ages
- 6 weeks to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children between ages 6 weeks to 24 months
- first episode of wheezing
- diagnosis of moderate to severe bronchiolitis: The patients are ranked as moderately to severely ill according to the Wang clinical severity score
Key exclusion criteria (9 listed)
- Children with mild bronchiolitis (Wang score < 5)
- Children with pre-existent cardiac disease
- Children with clinically significant chronic respiratory disease
- Immunocompromised children
- Children with a gestational age at birth less than 34 weeks
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 |
|---|---|---|
| NaCl 3%Also: Mucoclear 3%NaCl 3%: 4ml QID | Drug | NaCl 3% inhalations + standard therapy |
| Standard therapyStandard therapy includes suctioning nasal secretions, water-electrolyte balance maintenance and oxygen supplementation when needed | Other | NaCl 3% inhalations + standard therapy, Standard therapy |
Primary outcome
length of hospital stay
Time frame: 2 years
The length of stay is defined as the time between study entry and the time at which the child reach protocol-defined discharge criteria as measured by the physician in charge.
5 secondary outcomes
transfer rate to ICU
Time frame: 2 years
readmission rate in the next 7 days following discharge
Time frame: 2 years
Wang clinical severity score evolution
Time frame: 2 years
adverse events
Time frame: 2 years
Patients' ability to feed
Time frame: 2 years
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 19 Aug 2016.
- Derived from this study: PubMed 31488402Jaquet-Pilloud R, Verga ME, Russo M, Gehri M, Pauchard JY. Nebulised hypertonic saline in moderate-to-severe bronchiolitis: a randomised clinical trial. Arch Dis Child. 2020 Mar;105(3):236-240. doi: 10.1136/archdischild-2019-317160. Epub 2019 Sep 5.
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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.
Jean-Yves Pauchard study director
Hôpital de l'Enfance, Lausanne, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NaCl 3% and Standard therapy in people with Moderate to Severe Bronchiolitis, run by Raphaelle Jaquet-Pilloud at 1 site in Switzerland.
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 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: finished, as of the sponsor's last update on 19 Aug 2016. 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 Switzerland. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
length of hospital stay (time frame: 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 NCT01812525, 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 Aug 2016.