Trial | NCT01812525  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    120
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.
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.
Study Started
Mar 31
2013
Primary Completion
Apr 30
2016
Study Completion
Apr 30
2016
Last Update
Aug 19
2016
Estimate

Drug NaCl 3%

NaCl 3%: 4ml QID

  • Other names: Mucoclear 3%

Other Standard therapy

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

NaCl 3% inhalations + standard therapy Active Comparator

In this group, patients receive NaCl 3% inhalations ( 4ml QID) together with standard therapy. Standard therapy includes suctioning nasal secretions, water-electrolyte balance maintenance and oxygen supplementation when needed.

Standard therapy Placebo Comparator

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

Criteria 

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
No Results Posted