---
title: Budesonide for Emergency Treatment of Acute Wheezing in Children
nct_id: NCT00733317
overall_status: COMPLETED
phase: PHASE4
sponsor: Kecioren Education and Training Hospital
study_type: INTERVENTIONAL
primary_condition: Asthma
countries: Turkey (Türkiye)
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00733317.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00733317"
ct_last_update_post_date: 2011-12-20
last_seen_at: "2026-05-12T06:50:00.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Budesonide for Emergency Treatment of Acute Wheezing in Children

**Official Title:** Phase 4 Study of Budesonide for Emergency Treatment of Acute Wheezing in Children

**NCT ID:** [NCT00733317](https://clinicaltrials.gov/study/NCT00733317)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 100
- **Lead Sponsor:** Kecioren Education and Training Hospital
- **Conditions:** Asthma, Acute Asthma
- **Start Date:** 2007-09
- **Completion Date:** 2009-12
- **CT.gov Last Update:** 2011-12-20

## Brief Summary

The purpose of this study is to determine if adding nebulized budesonide to the systemic steroid for treatment of acute wheezing has any additive benefit in the emergency room.

## Detailed Description

Context: Inhaled steroids reduced admission rates in patients with acute asthma, but it is unclear if there is a benefit of inhaled corticosteroids when used in addition to systemic corticosteroids. There is insufficient evidence that inhaled corticosteroids result in clinically important changes in pulmonary function or clinical scores when used in acute asthma. Similarly, it was mentioned in the Cochrane Database of Systematic Reviews that further research is needed to clarify if there is a benefit of inhaled corticosteroids when used in addition to systemic steroids.

Objective: To determine if adding nebulized budesonide to the systemic steroid for treatment of acute wheezing in the emergency room has any benefit on, symptom score, hospitalization rate and time to discharge from emergency room.

Study Design/Setting/Participants: A double-blind, randomized, controlled trial of nebulized budesonide versus placebo for children 6 months to 6 years of age who have admitted to the emergency room for acute wheezing.

Intervention: Participants will receive standard therapy including SCS, albuterol, and ipratropium bromide and will be randomly assigned to also receive either nebulized BIS or saline.

Study Measures: Differences in asthma scores, vital signs, and the need for hospitalization will be compared between treatment groups.

## Eligibility

- **Minimum age:** 6 Months
- **Maximum age:** 6 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Children who have recurrent wheezing attacks and admitted to the emergency room for acute wheezing
* Pulmonary index score of 7-13
* Parental/guardian permission (informed consent) and if appropriate, child assent

Exclusion Criteria:

* Systemic corticosteroid use in the last 30 days
* Chronic lung diseases including cystic fibrosis
* Immunodeficiency
* Cardiac disease requiring surgery or medications
* Adverse drug reaction or allergy to budesonide, albuterol, ipratropium bromide, prednisone, prednisolone, or methylprednisolone
* Known renal or hepatic dysfunction
* Impending respiratory failure requiring positive pressure ventilation
* Immune deficiency
* Gastroesophageal reflux disease
* Suspected foreign body aspiration or croup
* Anatomic abnormalities of the respiratory tract
```

## Arms

- **1-Budesonide nebulized suspension** (ACTIVE_COMPARATOR) — Children will receive 0.5 mg/ml budesonide nebules every 20 minutes for 3 times and will not give after 3 doses
- **2- 0.9% saline** (PLACEBO_COMPARATOR) — Children will receive 2 ml of saline every 20 minutes for 3 times and will not give after 3 doses

## Interventions

- **0.5 mg/ml budesonide nebules** (DRUG) — Children will receive 0.5 mg/ml budesonide nebules every 20 minutes for 3 times
- **Saline** (DRUG) — Children will receive 2 ml of saline every 20 minutes for 3 times

## Primary Outcomes

- **Pulmonary index score at 2 to 4 hours** _(time frame: 2 to 4 hours)_

## Secondary Outcomes

- **Hospital admission rates** _(time frame: 4 hours)_
- **Proportion of subjects improving from severe to moderate, severe to mild, and moderate to mild.** _(time frame: 4 hours)_
- **Respiratory rate** _(time frame: 2 hours)_
- **Oxygen saturation** _(time frame: 2 hours)_
- **Time to discharge from the Emergency Department to home** _(time frame: 2 to 4 hours)_
- **Adverse reactions.** _(time frame: 2-5 days)_

## Locations (1)

- Kecioren Education and Training Hospital, Ankara, Kecioren, Turkey (Türkiye)

## Recent Field Changes (last 30 days)

- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `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.maxAge` — 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)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.kecioren education and training hospital|ankara|kecioren|turkey (türkiye)` — added _(2026-05-12)_

---

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