Completed

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

What is being tested

NaCl 3%

+ Standard therapy

DrugOther

Who is being recruted

Bronchial Diseases+5

+ Bronchitis

+ Infections

+12 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 3

Interventional

Study Start: March 2013

See protocol details

Summary

Principal SponsorRaphaelle Jaquet-Pilloud

Last updated: August 19, 2016

Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01812525

Principal SponsorRaphaelle Jaquet-Pilloud

Last updated: August 19, 2016

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

120 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial DiseasesBronchitisInfectionsLung DiseasesLung Diseases, ObstructiveRespiratory Tract DiseasesRespiratory Tract InfectionsBronchiolitis

Criteria

3 inclusion criteria required to participate

children between ages 6 weeks to 24 months

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

first episode of wheezing

9 exclusion criteria prevent from participating

Children who received bronchodilators within 24 hours before presentation

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

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

Children with a gestational age at birth less than 34 weeks

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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.

Group II

Placebo

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Hôpital de l'Enfance

Lausanne, SwitzerlandOpen Hôpital de l'Enfance in Google Maps

CompletedOne Study Center