Moderate to Severe Bronchiolitis: Standard Therapy Versus Therapy With NaCl 3% Inhalations

Moderate to Severe Bronchiolitis Clinical Trial

Official title:

Moderate to Severe Bronchiolitis: Standard Therapy Versus Therapy With NaCl 3%

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01812525
• Other study ID #: 453/12
• Status: Completed
• Phase: Phase 3
• First received: March 14, 2013
• Last updated: August 17, 2016
• Start date: March 2013
• Est. completion date: April 2016

Study information

• Verified date: August 2016
• Source: Hôpital de L'Enfance
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

Our study will investigate inhalation therapy of NaCl 3% compared to standard therapy with no inhalation in the treatment of moderate to severe bronchiolitis. The impact on length of hospital stay will be analyzed.

Description:

Acute viral bronchiolitis is the most common lower respiratory tract infection in the first year of life and leads to a large number of hospital admissions. The only recommended treatment is supportive. However many different types of drug inhalations have been studied but their efficacy remains controversial.

Our study will compare recommended supportive therapy to supportive therapy combined to hypertonic saline (NaCl 3%) inhalations in the treatment of moderate to severe bronchiolitis. This will be the first study to use a true control group with no inhalation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Weeks to 24 Months

Eligibility

Inclusion Criteria:

• children between ages 6 weeks to 24 months

• first episode of wheezing

• diagnosis of moderate to severe bronchiolitis: The patients are ranked as moderately to severely ill according to the Wang clinical severity score

Exclusion Criteria:

• Children with mild bronchiolitis (Wang score < 5)

• Children with pre-existent cardiac disease

• Children with clinically significant chronic respiratory disease

• Immunocompromised children

• Children with a gestational age at birth less than 34 weeks

• Children who received immunoprophylaxis therapy (i.e RSV immune globulin therapy)

• Children who received corticosteroid in any form in the preceding 2 weeks before presentation

• Children who received bronchodilators within 24 hours before presentation

• Children with critical illness at presentation requiring immediate admission to intensive care unit

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchiolitis
• Moderate to Severe Bronchiolitis

Intervention

Drug:
• NaCl 3%
NaCl 3%: 4ml QID

Other:
• Standard therapy
Standard therapy includes suctioning nasal secretions, water-electrolyte balance maintenance and oxygen supplementation when needed

Locations

Country	Name	City	State
Switzerland	Hôpital de l'Enfance	Lausanne	Vaud

Sponsors (2)

Lead Sponsor	Collaborator
Raphaelle Jaquet-Pilloud	Swiss Foundation for the Health of Children and Adolescents

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	length of hospital stay	The length of stay is defined as the time between study entry and the time at which the child reach protocol-defined discharge criteria as measured by the physician in charge.	2 years	No
Secondary	transfer rate to ICU		2 years	No
Secondary	readmission rate in the next 7 days following discharge		2 years	No
Secondary	Wang clinical severity score evolution		2 years	No
Secondary	adverse events		2 years	Yes
Secondary	Patients' ability to feed		2 years	No