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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: September 2008

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.

Intervention(s) in this Clinical Trial

• 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.
• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Salbutamol is diluted in hypertonic (3%) saline.
• Active Comparator: 2
  • Salbutamol is diluted in normal (0.9%) saline.

Primary Measures

• Change in the respiratory distress score (Tal) between the basal score and the final score after 3 salbutamol nebulizations
  • Time Frame: 1 hour
    Safety Issue?: No

Secondary Measures

• Change in the respiratory distress score (Tal) between the basal score and the first nebulization
  • Time Frame: 15 to 20 minutes
    Safety Issue?: No
• 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
    Safety Issue?: No
• Change in pulse oxymetry reading between the basal score and after each of the three nebulizations
  • Time Frame: 1 hour
    Safety Issue?: No
• 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
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 1 Month

Maximum Age for this Clinical Trial: 24 Months

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University Diego Portales

Overall Clinical Trial Officials and Contacts

Irmeli Roine, MD, PhD Principal Investigator University Diego Portales  

Overall Contact: Irmeli Roine, MD, PhD +56-2-6762916 irmeli.roine@prof.udp.cl

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00696540

Study ID Number: UDP-CT1-08

ClinicalTrials.gov Identifier: NCT00696540

Health Authority: Chile: Instituto de Salud Publica de Chile