BronchiolitisPhase 2/3NCT00151905
The Use of an Inhaled Salt Solution to Treat Viral Lung Infections in Infants.
A Phase 2/3 study testing 3 % hypertonic saline in people with Bronchiolitis, run by Sheikh Khalifa Medical City at 3 sites in 2 countries.
Trial summary
Bronchiolitis is a common viral lung infection in infants. Standard treatment often includes the use of inhaled medications which are usually first mixed with a standard salt solution. Read more about this study
- Who is it for?
- Ages Up to 18 months
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- 3 % hypertonic saline
- How many people
- Not given
- Where
- 3 sitesin 2 countries
- Study dates
- Nov 2003to Sep 2006
- Phase
- Phase 2/3
- 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 Up to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Corrected age maximum 18 months, plus
- History of preceding viral upper respiratory tract infection, plus
- Presence of wheezing and/or crackles on auscultation, plus
- Respiratory Distress Assessment Instrument (RDAI) score of 4 or greater, or oxygen saturation of 93% or less in room air, plus
- Admitted to hospital
Who cannot join
- Prior history of wheezing, or
- History of chronic cardiopulmonary disease or immunodeficiency, or
- Critical illness at presentation requiring admission to ICU, or
- Use of nebulized hypertonic saline within previous 12 hours, or
- Prematurity (gestational age 34 weeks or less).
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Canada2 sites
Kingston General Hospital
Kingston, Ontario, K7L 2V7
Victoria General Hospital
Victoria, British Columbia
United Arab Emirates1 site
Sheikh Khalifa Medical City
Abu Dhabi, Abu Dhabi Emirate, 51900
About this study
Official title: Nebulized Hypertonic Saline in the Treatment of Bronchiolitis in Infants
Bronchiolitis is a common viral lung infection in infants. Standard treatment often includes the use of inhaled medications which are usually first mixed with a standard salt solution. Inhalation of a more concentrated salt solution (hypertonic saline) has been successfully used to treat other types of lung disease in children and adults. The purpose of this study is to see if using inhaled hypertonic saline helps infants with bronchiolitis get better more quickly.
Read the detailed description
Bronchiolitis is a common illness in infants and is associated with a significant morbidity. Standard therapy is controversial and largely ineffective; care is mostly supportive although nebulized medications continue to be commonly used. These medications are typically mixed with normal saline to produce a sufficient volume for efficient nebulization.
Inhaled hypertonic saline has been used to aid airway clearance in children with cystic fibrosis. It has also been used, in low dose, in two small studies in children with bronchiolitis. The current study is a randomized, double-blind, placebo-controlled, multi-center trial comparing frequent dosing with 3% hypertonic saline compared to normal saline in the treatment of infants hospitalized with bronchiolitis.
- Conditions
- Bronchiolitis
- Being tested
- 3 % hypertonic saline
- Keywords
- bronchiolitis, hypertonic saline
- 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 salineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2005 (estimated)
- Study startNov 2003
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Sheikh Khalifa Medical City
- Sponsor type
- University, hospital or other
- Investigators
- Brian A Kuzik, MD, FRCP, Principal investigator, Sheikh Khalifa Medical City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00151905
- Sponsor's protocol ID
- RC-09
- Status last verified
- Sep 2005
- First submitted
- 7 Sep 2005
- Last updated
- 7 May 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nebulized Hypertonic Saline in the Treatment of Bronchiolitis in Infants
- ClinicalTrials.gov ID
- NCT00151905
- Acronym / sponsor ID
- RC-09
- Conditions
- Bronchiolitis
- Keywords
- bronchiolitis, hypertonic saline
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Sheikh Khalifa Medical CityUniversity, hospital or other
- Study start
- Nov 2003
- Study completion
- Sep 2006
- First posted
- 9 Sep 2005 (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.
Bronchiolitis is a common viral lung infection in infants. Standard treatment often includes the use of inhaled medications which are usually first mixed with a standard salt solution. Inhalation of a more concentrated salt solution (hypertonic saline) has been successfully used to treat other types of lung disease in children and adults. The purpose of this study is to see if using inhaled hypertonic saline helps infants with bronchiolitis get better more quickly.
Detailed description
Bronchiolitis is a common illness in infants and is associated with a significant morbidity. Standard therapy is controversial and largely ineffective; care is mostly supportive although nebulized medications continue to be commonly used. These medications are typically mixed with normal saline to produce a sufficient volume for efficient nebulization.
Inhaled hypertonic saline has been used to aid airway clearance in children with cystic fibrosis. It has also been used, in low dose, in two small studies in children with bronchiolitis. The current study is a randomized, double-blind, placebo-controlled, multi-center trial comparing frequent dosing with 3% hypertonic saline compared to normal saline in the treatment of infants hospitalized with bronchiolitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- Up to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Corrected age maximum 18 months, plus
- History of preceding viral upper respiratory tract infection, plus
- Presence of wheezing and/or crackles on auscultation, plus
- Respiratory Distress Assessment Instrument (RDAI) score of 4 or greater, or oxygen saturation of 93% or less in room air, plus
- Admitted to hospital
Key exclusion criteria (5 listed)
- Prior history of wheezing, or
- History of chronic cardiopulmonary disease or immunodeficiency, or
- Critical illness at presentation requiring admission to ICU, or
- Use of nebulized hypertonic saline within previous 12 hours, or
- Prematurity (gestational age 34 weeks or less).
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 | Drug | – |
Primary outcome
Length of stay.
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 7 May 2007.
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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 A Kuzik, MD, FRCP principal investigator
Sheikh Khalifa Medical City
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 3 % hypertonic saline in people with Bronchiolitis, run by Sheikh Khalifa Medical City at 3 sites in 2 countries.
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 5 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: finished, as of the sponsor's last update on 7 May 2007. 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, United Arab Emirates. 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 combined 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.
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 stay.. 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 7 May 2007.