---
title: Efficacy and Safety of 3% Hypertonic Saline Inhalation (24h vs 72h) to Treat Acute Bronchiolitis in Hospitalized Infants
nct_id: NCT02538458
overall_status: COMPLETED
phase: PHASE4
sponsor: University Hospital, Grenoble
study_type: INTERVENTIONAL
primary_condition: Bronchiolitis
countries: France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02538458.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02538458"
ct_last_update_post_date: 2017-11-06
last_seen_at: "2026-05-12T06:44:11.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Efficacy and Safety of 3% Hypertonic Saline Inhalation (24h vs 72h) to Treat Acute Bronchiolitis in Hospitalized Infants

**Official Title:** Effects of Reduction of the Length of Treatment by Nebulized 3% Hypertonic Saline From 72 to 24 Hours on Clinical Remission, in Children Younger Than 12 Month Hospitalized for Acute Bronchiolitis. BRONDUSAL

**NCT ID:** [NCT02538458](https://clinicaltrials.gov/study/NCT02538458)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 120
- **Lead Sponsor:** University Hospital, Grenoble
- **Collaborators:** AGIR à Dom
- **Conditions:** Bronchiolitis
- **Start Date:** 2014-11
- **Completion Date:** 2016-03
- **CT.gov Last Update:** 2017-11-06

## Brief Summary

Efficacy/Safety of 3% hypertonic saline inhalation (24H vs 72H) to treat acute bronchiolitis in infants.

## Detailed Description

In acute bronchiolitis in infants, 3% hypertonic saline nebulizations proved to be efficient, reducing the hospitalization length and clinical severity scores. Among the questions remaining, treatment length is still being discussed in the literature. The trial hypothesis is that the efficiency of a 24 hours treatment by 3% hypertonic saline is not inferior to a 72 hours treatment, in acute bronchiolitis in infants. The primary objective of the study is to compare the efficiency of a 24 hours treatment by 3 % hypertonic saline, versus a 72 hours treatment maximum, on clinical remission, judged by the Wang score measured 72 hours after starting treatment, in children younger than 12 month hospitalized for acute bronchiolitis.

## Eligibility

- **Minimum age:** 1 Minute
- **Maximum age:** 12 Months
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* 1st or 2nd episode of acute bronchiolitis, defined by respiratory symptoms episode with initial rhinitis, then cough, then one of the following symptoms : wheezing, crackling, respiratory distress
* Winter epidemic period from November, the 15th, to March the 15th
* Age \< 12 months
* Admission Wang score included between 4 and 8
* Infant hospitalized for gravity clinical criteria of severity
* Nebulized 3 % hypertonic saline treatment since less than 24 hours
* Infant with social security card coverage
* Free consent of at least one of the parental authority holder

Exclusion Criteria:

* Pulmonary, cardiac or neurologic chronic underlying disease
* Prematurity \< 32 GW
* Asthma (3rd episode or more)
* Admission oxygen saturation level \< 85 %, Wang score ≥ 9
```

## Arms

- **Test group** (ACTIVE_COMPARATOR) — 3 % hypertonic saline up to 72H.
- **Placebo control group** (PLACEBO_COMPARATOR) — * 3 % hypertonic saline up to 24H.
* Followed by 48 hours of placebo (nebulized 0.9% normal saline).

## Interventions

- **3 % hypertonic saline up to 72H** (DRUG) — Treatment by inhalation of 3 % hypertonic saline, up to 72H. Test group.
- **3 % hypertonic saline up to 24H** (DRUG) — * Treatment by inhalation of 3 % hypertonic saline, up to 24H.
* followed by 48h of placebo : isotonic saline inhalation. Placebo control group.

## Primary Outcomes

- **Wang score after 72 hours of treatment** _(time frame: 72 hours)_

## Secondary Outcomes

- **Recovery time** _(time frame: From Day 1 to end of the hospitalisation within 2 weeks, assessed at EOS (End of study for the patient, meaning discharge from hospital))_
- **To determine percentage of patient needing transfer to the PICU or use of mechanical ventilation** _(time frame: From Day 1 to end of the hospitalisation, assessed at EOS (End of study for the patient, meaning discharge from hospital))_
- **To assess average time of Oxygen therapy** _(time frame: From Day 1 to end of the hospitalisation, assessed at EOS (End of study for the patient, meaning discharge from hospital))_
- **To assess average time of Tube feeding** _(time frame: From Day 1 to end of the hospitalisation, assessed at EOS (End of study for the patient, meaning discharge from hospital))_
- **To determine variation of Wang score during hospitalisation** _(time frame: measured at Day 1, 2, 3, 4 and day of discharge.)_
- **To determine percentage of patient with Adverse Event** _(time frame: From Day 1 to end of the hospitalisation, assessed at EOS (End of study for the patient, meaning discharge from hospital))_

## Locations (1)

- Hôpital Couple Enfant, Grenoble, France

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.hôpital couple enfant|grenoble||france` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT02538458*  
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