BronchiolitisPhase 2HypertonicNCT00696540
Hypertonic Saline for Outpatient Bronchiolitis
A Phase 2 study testing Inhalation of salbutamol diluted in hypertonic saline and Inhalation of salbutamol diluted in normal saline in people with Bronchiolitis and Respiratory Distress, run by University Diego Portales at 1 site in Chile.
Trial summary
We will study if small children who become ill with respiratory distress during the RSV epidemic are better relieved with salbutamol nebulizations diluted in hypertonic (3%), instead of normal (0.9%) saline. Read more about this study
- Who is it for?
- Ages 1 month to 24 months
- Conditions the study is for
- Bronchiolitis, Respiratory Distress
- What is being tested?
- Inhalation of salbutamol diluted in hypertonic saline and Inhalation of salbutamol diluted in normal saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteChile
- Study dates
- Jun 2008to Oct 2008
- 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
- Age 1 to 24 months
- Mild to moderate respiratory distress (Tal score below 9)
- Up to 5 days of respiratory symptoms, including today
- Expiratory wheezing heard on chest auscultation
- Indication of salbutamol nebulization treatment by attending physician
Who cannot join
- Two prior episodes of wheezing
- Premature birth (below 38 weeks), if below 6 months of age
- Lobar pneumonia
- Body temperature above 38 degree Celsius
- Use of salbutamol during the previous 6 hours
- Pulse oxymetry reading below 90%
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- Congenital heart disease
- Chronic pulmonary disease: Asthma, cystic fibrosis, bronchopulmonary dysplasia
- Other chronic or genetic condition or disease
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Clínica Vespucio
Santiago, 00300
Ricardo Mercado, MD, +56-2-8206500, rmercado@ssmso.cl
Patricio Olivares, MD, +56-2-8206500, patovares@gmail.com
About this study
Official title: Safety and Efficacy of Hypertonic Vrs. Normal Saline as Diluent of Salbutamol to Reduce Respiratory Distress in Outpatients With the Clinical Diagnosis of Bronchiolitis During the RSV Epidemic.
We will study if small children who become ill with respiratory distress during the RSV epidemic are better relieved with salbutamol nebulizations diluted in hypertonic (3%), instead of normal (0.9%) saline.
Read the detailed description
In Santiago, Chile, a near collapse of health services is a notorious feature of every winter when vast numbers of small children line for attention because of respiratory distress caused by a probable RSV infection.
Our study will examine if nebulized salbutamol diluted in hypertonic (3%), instead of normal (0.9%) saline, provides better relief in outpatients.
If hypertonic saline proves safe and effective, the patients could be better managed and the pressure for attention diminished at a low cost, by a simple change in the saline ampule.
- Conditions
- Bronchiolitis, Respiratory Distress
- Being tested
- Inhalation of salbutamol diluted in hypertonic saline, Inhalation of salbutamol diluted in normal saline
- Keywords
- Bronchiolitis, respiratory distress, hypertonic saline
- Medical subject headings
- Bronchiolitis, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhalation of salbutamol diluted in hypertonic salineDrug
Also called Albuterol diluted in hypertonic saline
The first of 3 nebulizations of 0.5 mg of Salbutamol is diluted in 3.5 ml of hypertonic (3%) saline. The second and the third are diluted in normal (0.9%) saline.
Inhalation of salbutamol diluted in normal salineDrug
Also called Albuterol diluted in normal saline
The 3 nebulizations of 0.5 mg of Salbutamol are diluted in 3.5 ml of normal (0.9%) saline.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Salbutamol is diluted in hypertonic (3%) saline. Receives: Drug: Inhalation of salbutamol diluted in hypertonic saline |
| 2 | Active comparator | Salbutamol is diluted in normal (0.9%) saline. Receives: Drug: Inhalation of salbutamol diluted in normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the respiratory distress score (Tal) between the basal score and the final score after 3 salbutamol nebulizations
Measured: 1 hour
Secondary outcomes (4)
Change in the respiratory distress score (Tal) between the basal score and the first nebulization
Measured: 15 to 20 minutes
Change in the respiratory distress score (Tal) between the basal score and the second nebulization
Measured: 15 to 20 minutes after the first nebulization
Change in pulse oxymetry reading between the basal score and after each of the three nebulizations
Measured: 1 hour
Change in cardiac frequency, irritability, general condition or anything else between the basal score and the first, second and third nebulization
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionSep 2008 (estimated)
- Study completionOct 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Diego Portales
- Sponsor type
- University, hospital or other
- Collaborators
- Clínica Vespucio, Santiago, Chile
- Investigators
- Irmeli Roine, MD, PhD, Principal investigator, University Diego PortalesRicardo Mercado, MD, Study director, Clinica Vespucio, Santiago, Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00696540
- Sponsor's protocol ID
- UDP-CT1-08
- Acronym
- Hypertonic
- Status last verified
- Jun 2008
- First submitted
- 9 Jun 2008
- Last updated
- 12 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sarrell EM, Tal G, Witzling M, Someck E, Houri S, Cohen HA, Mandelberg A. Nebulized 3% hypertonic saline solution treatment in ambulatory children with viral bronchiolitis decreases symptoms. Chest. 2002 Dec;122(6):2015-20. doi: 10.1378/chest.122.6.2015.
PubMed 12475841Mandelberg A, Tal G, Witzling M, Someck E, Houri S, Balin A, Priel IE. Nebulized 3% hypertonic saline solution treatment in hospitalized infants with viral bronchiolitis. Chest. 2003 Feb;123(2):481-7. doi: 10.1378/chest.123.2.481.
PubMed 12576370
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Hypertonic Vrs. Normal Saline as Diluent of Salbutamol to Reduce Respiratory Distress in Outpatients With the Clinical Diagnosis of Bronchiolitis During the RSV Epidemic.
- ClinicalTrials.gov ID
- NCT00696540
- Acronym / sponsor ID
- Hypertonic / UDP-CT1-08
- Conditions
- Bronchiolitis, Respiratory Distress
- Keywords
- Bronchiolitis, respiratory distress, hypertonic saline
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- University Diego PortalesUniversity, hospital or other
- Collaborators
- Clínica Vespucio, Santiago, Chile
- Study start
- Jun 2008
- Primary completion
- Sep 2008 (estimated)
- Study completion
- Oct 2008 (estimated)
- First posted
- 12 Jun 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.
We will study if small children who become ill with respiratory distress during the RSV epidemic are better relieved with salbutamol nebulizations diluted in hypertonic (3%), instead of normal (0.9%) saline.
Detailed description
In Santiago, Chile, a near collapse of health services is a notorious feature of every winter when vast numbers of small children line for attention because of respiratory distress caused by a probable RSV infection.
Our study will examine if nebulized salbutamol diluted in hypertonic (3%), instead of normal (0.9%) saline, provides better relief in outpatients.
If hypertonic saline proves safe and effective, the patients could be better managed and the pressure for attention diminished at a low cost, by a simple change in the saline ampule.
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 |
|---|---|---|
| 1 | Experimental | Drug: Inhalation of salbutamol diluted in hypertonic salineSalbutamol is diluted in hypertonic (3%) saline. |
| 2 | Active comparator | Drug: Inhalation of salbutamol diluted in normal salineSalbutamol is diluted in normal (0.9%) saline. |
Who may qualify
- Ages
- 1 month to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age 1 to 24 months
- Mild to moderate respiratory distress (Tal score below 9)
- Up to 5 days of respiratory symptoms, including today
- Expiratory wheezing heard on chest auscultation
- Indication of salbutamol nebulization treatment by attending physician
Key exclusion criteria (9 listed)
- Two prior episodes of wheezing
- Premature birth (below 38 weeks), if below 6 months of age
- Lobar pneumonia
- Body temperature above 38 degree Celsius
- Use of salbutamol during the previous 6 hours
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 |
|---|---|---|
| Inhalation of salbutamol diluted in hypertonic salineAlso: Albuterol diluted in hypertonic salineThe first of 3 nebulizations of 0.5 mg of Salbutamol is diluted in 3.5 ml of hypertonic (3%) saline. The second and the third are diluted in normal (0.9%) saline. | Drug | 1 |
| Inhalation of salbutamol diluted in normal salineAlso: Albuterol diluted in normal salineThe 3 nebulizations of 0.5 mg of Salbutamol are diluted in 3.5 ml of normal (0.9%) saline. | Drug | 2 |
Primary outcome
Change in the respiratory distress score (Tal) between the basal score and the final score after 3 salbutamol nebulizations
Time frame: 1 hour
4 secondary outcomes
Change in the respiratory distress score (Tal) between the basal score and the first nebulization
Time frame: 15 to 20 minutes
Change in the respiratory distress score (Tal) between the basal score and the second nebulization
Time frame: 15 to 20 minutes after the first nebulization
Change in pulse oxymetry reading between the basal score and after each of the three nebulizations
Time frame: 1 hour
Change in cardiac frequency, irritability, general condition or anything else between the basal score and the first, second and third nebulization
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2008.
- Background: PubMed 12475841Sarrell EM, Tal G, Witzling M, Someck E, Houri S, Cohen HA, Mandelberg A. Nebulized 3% hypertonic saline solution treatment in ambulatory children with viral bronchiolitis decreases symptoms. Chest. 2002 Dec;122(6):2015-20. doi: 10.1378/chest.122.6.2015.
- Background: PubMed 12576370Mandelberg A, Tal G, Witzling M, Someck E, Houri S, Balin A, Priel IE. Nebulized 3% hypertonic saline solution treatment in hospitalized infants with viral bronchiolitis. Chest. 2003 Feb;123(2):481-7. doi: 10.1378/chest.123.2.481.
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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.
Irmeli Roine, MD, PhD principal investigator
University Diego Portales
Ricardo Mercado, MD study director
Clinica Vespucio, Santiago, Chile
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 Inhalation of salbutamol diluted in hypertonic saline and Inhalation of salbutamol diluted in normal saline in people with Bronchiolitis and Respiratory Distress, run by University Diego Portales at 1 site in Chile.
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 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: status not confirmed, as of the sponsor's last update on 12 Jun 2008. 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 Chile. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irmeli Roine, MD, PhD (+56-2-6762916, irmeli.roine@prof.udp.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the respiratory distress score (Tal) between the basal score and the final score after 3 salbutamol nebulizations (time frame: 1 hour). 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 NCT00696540, which also lists 2 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 12 Jun 2008.