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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2016-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Moderate to Severe Bronchiolitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NaCl 3% inhalations + standard therapy

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.

Group Type ACTIVE_COMPARATOR

NaCl 3%

Intervention Type DRUG

NaCl 3%: 4ml QID

Standard therapy

Intervention Type OTHER

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

Standard therapy

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

Group Type PLACEBO_COMPARATOR

Standard therapy

Intervention Type OTHER

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

Interventions

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NaCl 3%

NaCl 3%: 4ml QID

Intervention Type DRUG

Standard therapy

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

Intervention Type OTHER

Other Intervention Names

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Mucoclear 3%

Eligibility Criteria

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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

Minimum Eligible Age

6 Weeks

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No