NCT00733473

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 children who have hospitalized for acute wheezing.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4 asthma

Timeline
Completed

Started Sep 2007

Typical duration for phase_4 asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 13, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

December 20, 2011

Status Verified

December 1, 2011

Enrollment Period

2.3 years

First QC Date

August 12, 2008

Last Update Submit

December 17, 2011

Conditions

AsthmaAcute Asthma

Keywords

WheezingAcute asthmaChildren

Outcome Measures

Primary Outcomes (1)

  • Time to discharge from the hospital to home

    1-5 days

Secondary Outcomes (4)

  • Pulmonary index score

    1 to 5 days

  • Respiratory rate

    1 to 5 days

  • Oxygen saturation

    1 to 5 days

  • Adverse reactions.

    1 to 5 days

Study Arms (2)

1 Budesonide

ACTIVE COMPARATOR

This arm consist 50 children with recurrent wheezing who are hospitalized for wheezing epizode. They received 1 mg nebulized budesonide 2 times a day upto 5 days

Drug: Budesonide 0.5 mg/ml nebules

2 Placebo saline

PLACEBO COMPARATOR

This arm consist 50 children with recurrent wheezing who are hospitalized for wheezing epizode. They received 2ml of nebulized saline 2 times a day upto 5 days

Drug: % 0.9 Saline solution

Interventions

Budesonide 0.5 mg/ml nebulesDRUG

Children will receive 1 mg nebulized budesonide 2 times a day up to 5 days

Also known as: Pulmicort 0.5 mg/ml nebules
1 Budesonide
% 0.9 Saline solutionDRUG

Children will receive 2 ml of nebulized saline 2 times a day up to 5 days

2 Placebo saline

Eligibility Criteria

Age6 Months - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children who have recurrent wheezing attacks
  • Children who admitted to the hospital for acute wheezing
  • Clinical asthma score of 3-9
  • Parental/guardian permission (informed consent) and if appropriate, child assent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kecioren Education and Training Hospital

Ankara, Kecioren, 06380, Turkey (Türkiye)

Location

MeSH Terms

Conditions

AsthmaRespiratory Sounds

Interventions

BudesonideSaline Solution

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • C H Razi, MD

    Kecioren Education and Training Hospital

    STUDY DIRECTOR

  • C H Razi, MD

    Kecioren Education and Training Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 12, 2008

First Posted

August 13, 2008

Study Start

September 1, 2007

Primary Completion

December 1, 2009

Study Completion

January 1, 2010

Last Updated

December 20, 2011

Record last verified: 2011-12

Locations

TU(1)