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
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|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|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||74 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
- Change in the respiratory distress score (Tal) between the basal score and the final score after 3 salbutamol nebulizations [ Time Frame: 1 hour ]
- 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 ]
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|Ages Eligible for Study:||1 Month to 24 Months (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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%
- Congenital heart disease
- Chronic pulmonary disease: Asthma, cystic fibrosis, bronchopulmonary dysplasia
- Other chronic or genetic condition or disease
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
|Contact: Irmeli Roine, MD, PhDfirstname.lastname@example.org|
|Contact: Ricardo Mercado, MDemail@example.com|
|Santiago, Chile, 00300|
|Contact: Ricardo Mercado, MD +56-2-8206500 firstname.lastname@example.org|
|Contact: Patricio Olivares, MD +56-2-8206500 email@example.com|
|Principal Investigator:||Irmeli Roine, MD, PhD||University Diego Portales|
|Study Director:||Ricardo Mercado, MD||Clinica Vespucio, Santiago, Chile|
|Responsible Party:||Irmeli Roine, Facultad de Ciencias de la Salud, Universidad Diego Portales, Santiago. Chile|
|Other Study ID Numbers:||
|First Posted:||June 12, 2008 Key Record Dates|
|Last Update Posted:||June 12, 2008|
|Last Verified:||June 2008|
Bronchiolitis, respiratory distress, hypertonic saline
Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases, Obstructive
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Molecular Mechanisms of Pharmacological Action