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Hypertonic Saline for Outpatient Bronchiolitis (Hypertonic)

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ClinicalTrials.gov Identifier: NCT00696540
Recruitment Status : Unknown
Verified June 2008 by University Diego Portales.
Recruitment status was:  Recruiting
First Posted : June 12, 2008
Last Update Posted : June 12, 2008
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Bronchiolitis Respiratory Distress Drug: Inhalation of salbutamol diluted in hypertonic saline Drug: Inhalation of salbutamol diluted in normal saline Phase 2

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Study Start Date : June 2008
Estimated Primary Completion Date : September 2008
Estimated Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Salbutamol is diluted in hypertonic (3%) saline.
Drug: Inhalation 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.
Other Name: Albuterol diluted in hypertonic saline
Active Comparator: 2
Salbutamol is diluted in normal (0.9%) saline.
Drug: Inhalation 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.
Other Name: Albuterol diluted in normal saline


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria

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Ages Eligible for Study:   1 Month to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00696540


Contacts
Contact: Irmeli Roine, MD, PhD +56-2-6762916 irmeli.roine@prof.udp.cl
Contact: Ricardo Mercado, MD +56-9-3320792 rmercado@ssmso.cl

Locations
Chile
Clínica Vespucio Recruiting
Santiago, Chile, 00300
Contact: Ricardo Mercado, MD    +56-2-8206500    rmercado@ssmso.cl   
Contact: Patricio Olivares, MD    +56-2-8206500    patovares@gmail.com   
Sponsors and Collaborators
University Diego Portales
Clínica Vespucio, Santiago, Chile
Investigators
Principal Investigator: Irmeli Roine, MD, PhD University Diego Portales
Study Director: Ricardo Mercado, MD Clinica Vespucio, Santiago, Chile
More Information

Publications:
Responsible Party: Irmeli Roine, Facultad de Ciencias de la Salud, Universidad Diego Portales, Santiago. Chile
ClinicalTrials.gov Identifier: NCT00696540     History of Changes
Other Study ID Numbers: UDP-CT1-08
First Posted: June 12, 2008    Key Record Dates
Last Update Posted: June 12, 2008
Last Verified: June 2008

Keywords provided by University Diego Portales:
Bronchiolitis, respiratory distress, hypertonic saline

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action