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Status unknownNCT00696540HypertonicUpdated Jun 12, 2008

Hypertonic Saline for Outpatient Bronchiolitis

A Phase 2 interventional study of Inhalation of salbutamol diluted in hypertonic saline and Inhalation of salbutamol diluted in normal saline in Bronchiolitis and Respiratory Distress, sponsored by University Diego Portales. Status unknown at 1 site in Chile. Open to participants aged 1 Month to 24 Months. Per ClinicalTrials.gov, last updated 2008-06-12.

Sponsored by University Diego Portales · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2008), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
74
Allocation
Randomized
Ages
1 Month to 24 Months
Sex
All
01

Study 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 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.

02

Conditions studied

  • Bronchiolitis
  • Respiratory Distress

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Keywords

  • Bronchiolitis, respiratory distress, hypertonic saline
03

In context

Bronchiolitis

360 studies on the registry are indexed under Bronchiolitis; 43 are open to participants now.

This study's planned enrollment of 74 is close to the median of 80 across 249 interventional studies indexed under Bronchiolitis.

Browse Bronchiolitis studies →

Lead sponsor

University Diego Portales is the lead sponsor of 8 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Month to 24 Months
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age 1 to 24 months
  2. Mild to moderate respiratory distress (Tal score below 9)
  3. Up to 5 days of respiratory symptoms, including today
  4. Expiratory wheezing heard on chest auscultation
  5. Indication of salbutamol nebulization treatment by attending physician

Exclusion criteria

Exclusion Criteria:

  1. Two prior episodes of wheezing
  2. Premature birth (below 38 weeks), if below 6 months of age
  3. Lobar pneumonia
  4. Body temperature above 38 degree Celsius
  5. Use of salbutamol during the previous 6 hours
  6. Pulse oxymetry reading below 90%
  7. Congenital heart disease
  8. Chronic pulmonary disease: Asthma, cystic fibrosis, bronchopulmonary dysplasia
  9. Other chronic or genetic condition or disease
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
74 participants (estimated)

Study arms

  • Experimental
    1

    Salbutamol is diluted in hypertonic (3%) saline.

    Drug: Inhalation of salbutamol diluted in hypertonic saline

  • Active comparator
    2

    Salbutamol is diluted in normal (0.9%) saline.

    Drug: Inhalation of salbutamol diluted in normal saline

Interventions

  • DrugInhalation of salbutamol 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.

    Also known as: Albuterol diluted in hypertonic saline

  • DrugInhalation of salbutamol diluted in normal saline

    The 3 nebulizations of 0.5 mg of Salbutamol are diluted in 3.5 ml of normal (0.9%) saline.

    Also known as: Albuterol diluted in normal saline

06

What researchers measure

Primary outcomes

  1. Change in the respiratory distress score (Tal) between the basal score and the final score after 3 salbutamol nebulizations

    Time frame: 1 hour

Secondary outcomes

  1. Change in the respiratory distress score (Tal) between the basal score and the first nebulization

    Time frame: 15 to 20 minutes

  2. 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

  3. Change in pulse oxymetry reading between the basal score and after each of the three nebulizations

    Time frame: 1 hour

  4. 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

07

Study locations

1 of 1 sites recruiting
  • Clínica Vespucio
    Santiago, 00300, Chile
    Recruiting
08

References and documents

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 12475841 ↗
  • Mandelberg 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00696540
Lead sponsor
University Diego Portales
Collaborators
Clínica Vespucio, Santiago, Chile
First posted
Jun 12, 2008
Start date
Jun 2008
Primary completion
Sep 2008 (estimated)
Completion
Oct 2008 (estimated)
Last update
Jun 12, 2008

Study contacts

Irmeli Roine, MD, PhD
Contact
irmeli.roine@prof.udp.cl
+56-2-6762916
Ricardo Mercado, MD
Contact
rmercado@ssmso.cl
+56-9-3320792
Irmeli Roine, MD, PhD
principal investigator · University Diego Portales
Ricardo Mercado, MD
study director · Clinica Vespucio, Santiago, Chile

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.

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