Viral BronchiolitisPhase 2NCT00677729
Hypertonic Saline to Reduce Hospital Admissions in Bronchiolitis
A Phase 2 study testing solution contains 1 mg salbutamol plus 3% hypertonic saline and solution contains 1 mg salbutamol plus 0.9% saline in people with Viral Bronchiolitis, run by Queen's University at 3 sites in Canada.
Trial summary
Inhaled 3% hypertonic saline (HS) administered every 2-8 hours to infants admitted to hospital with viral bronchiolitis has been shown to improve airway clearance and reduces length of stay. Read more about this study
- Who is it for?
- Ages Up to 24 months
- Conditions the study is for
- Viral Bronchiolitis
- What is being tested?
- solution contains 1 mg salbutamol plus 3% hypertonic saline and solution contains 1 mg salbutamol plus 0.9% saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 3 sitesCanada
- Study dates
- Nov 2008to May 2009
- 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 Up to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- < 24 months.
- presenting to ER or outpatient department with moderately severe viral bronchiolitis defined as:
- history of viral upper respiratory tract infection within previous 7 days, plus
- presence of wheezing and/or crackles on chest auscultation, plus
- Respiratory Distress Assessment Instrument (RDAI, appendix B) score > 4 (of 17) or transcutaneous oxygen saturation (SaO2) < 94% in room air.
- Patient exclusion criteria:
Show all 10Show fewer
- history of immunodeficiency or chronic cardiopulmonary disease (other than past history of wheezing).
- critical illness at presentation.
- use of nebulized HS within previous 12 hr.
- prematurity (gestational age < 34 weeks).
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
The Royal Victoria Hospital
Barrie, Ontario, L4M 6M2
Kingston General Hospital
Kingston, Ontario, K7L 2V7
Religious Hospitallers of Saint Joseph of the Hotel Dieu of Kingston
Kingston, Ontario
About this study
Official title: Inhaled Hypertonic Saline to Reduce Hospital Admissions in Infants With Viral Bronchiolitis (HS in ER Study)
Inhaled 3% hypertonic saline (HS) administered every 2-8 hours to infants admitted to hospital with viral bronchiolitis has been shown to improve airway clearance and reduces length of stay.
Hypothesis: When infants first present to the ER, frequent administration of HS over a brief time period will provide significant symptom improvement such that the need for hospital admission will be reduced.
Objective: To determine in a randomized, controlled and double-blind fashion if the short term intensive use of inhaled 3% hypertonic saline (HS) in the Emergency Room (ER) can reduce the rate of hospital admission for infants presenting with moderately severe viral bronchiolitis.
Read the detailed description
Patients presenting to the Emergency Room (ER) or out-patient department with a diagnosis of moderately severe bronchiolitis (as defined by inclusion/exclusion criteria below) will be approached for entry into the study. After the initial routine assessment by the ER medical and nursing staff, informed consent will be obtained and the infant will be randomized to receive treatment in a double-blinded fashion with 4 ml of nebulized study solution containing 1 mg salbutamol (bronchodilator) plus either 3% hypertonic saline (HS, study group) or 0.9% saline (NS, control group) every 20 minutes for a total of 3 doses. After an observation period of 1 hour following the last dose, the infant will be reassessed by the attending physician in the ER for disposition (admit, discharge home, remain in ER for further treatment) at which point the infant's active involvement in the study will end. All subsequent therapy, if needed, will be at the sole discretion of the attending physician. The family of each recruited subject will be contacted by phone 7 days later to assess resolution of symptoms or the presence of any unexpected adverse effects.
Clinical response to the above treatment will also be determined independently by the study physician or designate utilizing a standardized respiratory scoring system, the Respiratory Distress Assessment Instrument (RDAI), at study entry and after the post-treatment observation period. The primary outcome measure is to compare the rate of admission to hospital between the study and control groups. A secondary outcome measure will involve the assessment of change in the RDAI between study entry and post-treatment.
The infant will remain in the ER throughout the study period and receive standard ongoing monitoring by the nursing staff. In the unlikely event of significant clinical worsening during this period, the ER physician on duty will be notified to assess and intervene as he/she feels appropriate. The site study investigator will be immediately notified of all such occurrences by the research assistant involved.
The study will be conducted over a single bronchiolitis season from November 1, 2008 to April 1, 2009. There will be 2 study sites as listed below with the name of the study site director.
- Royal Victoria Hospital of Barrie (Emergency Department), Barrie ON (B.A. Kuzik, MD, FRCP (lead investigator))
- Kingston General Hospital (Emergency Department) and Hotel Dieu Hospital (Emergency Department, Children's Outpatient Centre), Kingston ON (M. P. Flavin, MB, MRCP, FRCP)
- Conditions
- Viral Bronchiolitis
- Being tested
- solution contains 1 mg salbutamol plus 3% hypertonic saline, solution contains 1 mg salbutamol plus 0.9% saline
- Keywords
- bronchiolitis, hypertonic saline, infants
- Medical subject headings
- Bronchiolitis, Viral, Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
solution contains 1 mg salbutamol plus 3% hypertonic salineDrug
4 ml of nebulized study solution containing 1 mg salbutamol plus 3% hypertonic saline every 20 minutes for a total of 3 doses
solution contains 1 mg salbutamol plus 0.9% salineDrug
4 ml of nebulized study solution containing 1 mg salbutamol plus 0.9% saline (NaCl) every 20 minutes for a total of 3 doses
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 4 ml of nebulized study solution containing 1 mg salbutamol plus 3% hypertonic saline (NaCl) Receives: Drug: solution contains 1 mg salbutamol plus 3% hypertonic saline |
| 2 | Placebo comparator | 4 ml of nebulized study solution containing 1 mg salbutamol plus 0.9% saline (NaCl) Receives: Drug: solution contains 1 mg salbutamol plus 0.9% saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare the rate of admission to hospital between the study and control groups
Measured: 1 hour after treatment ends
Secondary outcomes (1)
change in the RDAI between study entry and post-treatment.
Measured: 1 hour after treatment ends
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2008 (estimated)
- Study startNov 2008
- Primary completionApr 2009
- Study completionMay 2009
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 Viral 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- Kingston Health Sciences Centre, Religious Hospitallers of Saint Joseph of the Hotel Dieu of Kingston, Royal Victoria Hospital Of Barrie
- Responsible party
- Principal investigator, Dr. Michael Flavin, Queen's University
- Investigators
- Brian Kuzik, MD, Principal investigator, The Royal Victoria Hospital of Barrie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00677729
- Sponsor's protocol ID
- HSERFLA
- Other IDs
- PAED-214-08
- Status last verified
- Nov 2015
- First submitted
- 2 May 2008
- Last updated
- 13 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kuzik BA, Flavin MP, Kent S, Zielinski D, Kwan CW, Adeleye A, Vegsund BC, Rossi C. Effect of inhaled hypertonic saline on hospital admission rate in children with viral bronchiolitis: a randomized trial. CJEM. 2010 Nov;12(6):477-84. doi: 10.1017/s1481803500012690.
PubMed 21073773
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaled Hypertonic Saline to Reduce Hospital Admissions in Infants With Viral Bronchiolitis (HS in ER Study)
- ClinicalTrials.gov ID
- NCT00677729
- Acronym / sponsor ID
- HSERFLA
- Conditions
- Viral Bronchiolitis
- Keywords
- bronchiolitis, hypertonic saline, infants
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- Kingston Health Sciences Centre, Religious Hospitallers of Saint Joseph of the Hotel Dieu of Kingston, Royal Victoria Hospital Of Barrie
- Study start
- Nov 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 14 May 2008 (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.
Inhaled 3% hypertonic saline (HS) administered every 2-8 hours to infants admitted to hospital with viral bronchiolitis has been shown to improve airway clearance and reduces length of stay.
Hypothesis: When infants first present to the ER, frequent administration of HS over a brief time period will provide significant symptom improvement such that the need for hospital admission will be reduced.
Objective: To determine in a randomized, controlled and double-blind fashion if the short term intensive use of inhaled 3% hypertonic saline (HS) in the Emergency Room (ER) can reduce the rate of hospital admission for infants presenting with moderately severe viral bronchiolitis.
Detailed description
Patients presenting to the Emergency Room (ER) or out-patient department with a diagnosis of moderately severe bronchiolitis (as defined by inclusion/exclusion criteria below) will be approached for entry into the study. After the initial routine assessment by the ER medical and nursing staff, informed consent will be obtained and the infant will be randomized to receive treatment in a double-blinded fashion with 4 ml of nebulized study solution containing 1 mg salbutamol (bronchodilator) plus either 3% hypertonic saline (HS, study group) or 0.9% saline (NS, control group) every 20 minutes for a total of 3 doses. After an observation period of 1 hour following the last dose, the infant will be reassessed by the attending physician in the ER for disposition (admit, discharge home, remain in ER for further treatment) at which point the infant's active involvement in the study will end. All subsequent therapy, if needed, will be at the sole discretion of the attending physician. The family of each recruited subject will be contacted by phone 7 days later to assess resolution of symptoms or the presence of any unexpected adverse effects.
Clinical response to the above treatment will also be determined independently by the study physician or designate utilizing a standardized respiratory scoring system, the Respiratory Distress Assessment Instrument (RDAI), at study entry and after the post-treatment observation period. The primary outcome measure is to compare the rate of admission to hospital between the study and control groups. A secondary outcome measure will involve the assessment of change in the RDAI between study entry and post-treatment.
The infant will remain in the ER throughout the study period and receive standard ongoing monitoring by the nursing staff. In the unlikely event of significant clinical worsening during this period, the ER physician on duty will be notified to assess and intervene as he/she feels appropriate. The site study investigator will be immediately notified of all such occurrences by the research assistant involved.
The study will be conducted over a single bronchiolitis season from November 1, 2008 to April 1, 2009. There will be 2 study sites as listed below with the name of the study site director.
- Royal Victoria Hospital of Barrie (Emergency Department), Barrie ON (B.A. Kuzik, MD, FRCP (lead investigator))
- Kingston General Hospital (Emergency Department) and Hotel Dieu Hospital (Emergency Department, Children's Outpatient Centre), Kingston ON (M. P. Flavin, MB, MRCP, FRCP)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: solution contains 1 mg salbutamol plus 3% hypertonic saline4 ml of nebulized study solution containing 1 mg salbutamol plus 3% hypertonic saline (NaCl) |
| 2 | Placebo comparator | Drug: solution contains 1 mg salbutamol plus 0.9% saline4 ml of nebulized study solution containing 1 mg salbutamol plus 0.9% saline (NaCl) |
Who may qualify
- Ages
- Up to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- < 24 months.
- presenting to ER or outpatient department with moderately severe viral bronchiolitis defined as:
- history of immunodeficiency or chronic cardiopulmonary disease (other than past history of wheezing).
- critical illness at presentation.
- use of nebulized HS within previous 12 hr.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| solution contains 1 mg salbutamol plus 3% hypertonic saline4 ml of nebulized study solution containing 1 mg salbutamol plus 3% hypertonic saline every 20 minutes for a total of 3 doses | Drug | 1 |
| solution contains 1 mg salbutamol plus 0.9% saline4 ml of nebulized study solution containing 1 mg salbutamol plus 0.9% saline (NaCl) every 20 minutes for a total of 3 doses | Drug | 2 |
Primary outcome
compare the rate of admission to hospital between the study and control groups
Time frame: 1 hour after treatment ends
1 secondary outcome
change in the RDAI between study entry and post-treatment.
Time frame: 1 hour after treatment ends
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 13 Nov 2015.
- Derived from this study: PubMed 21073773Kuzik BA, Flavin MP, Kent S, Zielinski D, Kwan CW, Adeleye A, Vegsund BC, Rossi C. Effect of inhaled hypertonic saline on hospital admission rate in children with viral bronchiolitis: a randomized trial. CJEM. 2010 Nov;12(6):477-84. doi: 10.1017/s1481803500012690.
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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.
Brian Kuzik, MD principal investigator
The Royal Victoria Hospital of Barrie
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing solution contains 1 mg salbutamol plus 3% hypertonic saline and solution contains 1 mg salbutamol plus 0.9% saline in people with Viral Bronchiolitis, run by Queen's University at 3 sites in Canada.
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 0 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 13 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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 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 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?
compare the rate of admission to hospital between the study and control groups (time frame: 1 hour after treatment ends). 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 NCT00677729, 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 13 Nov 2015.