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Effectiveness of Inhaled Corticosteroids in Preschool Children With Acute Dyspnea and Wheeze (ICS@ADP)

Primary Purpose

Wheezing, Dyspnea

Status
Terminated
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Beclomethasone
Placebo
Sponsored by
Princess Amalia Children's Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wheezing focused on measuring Child, Wheezing, Dyspnea, Inhaled corticosteroids

Eligibility Criteria

1 Year - 4 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children that are admitted to the paediatric ward of the Isala Klinieken in Zwolle for the first time with acute dyspnea and wheezing
  • Age 1 - 4 years
  • Child and parents must understand the Dutch language well
  • Informed consent

Exclusion Criteria:

  • Previous use of medication different than short-acting β2-agonists before hospital admission
  • Proven RSV bronchiolitis
  • Crackles during auscultation of the lungs (suggestive for RSV bronchiolitis)

Sites / Locations

  • Princess Amalia Children's Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Beclomethasone

Placebo

Arm Description

Inhaled corticosteroids

Placebo Comparator

Outcomes

Primary Outcome Measures

Number of unscheduled doctor visits for dyspnea and wheezing

Secondary Outcome Measures

PACQLQ scores and the use of additional asthma medication

Full Information

First Posted
August 18, 2009
Last Updated
January 3, 2018
Sponsor
Princess Amalia Children's Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT00962299
Brief Title
Effectiveness of Inhaled Corticosteroids in Preschool Children With Acute Dyspnea and Wheeze
Acronym
ICS@ADP
Official Title
Effectiveness of Inhaled Corticosteroids in Preschool Children Following Hospital Admission for Acute Dyspnea and Wheeze
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Why Stopped
recruitment was unsuccesfull, only 7 patient have been included untill 2012
Study Start Date
May 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Princess Amalia Children's Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the study is to investigate whether inhaled corticosteroids after a first hospital admission for acute dyspnea and wheeze is effective in reducing subsequent episodes of these complaints in children aged 1 to 4 years.
Detailed Description
Symptoms of dyspnea and wheeze occur frequently in young children with a cumulative incidence of 33% before the age of 3 and up to 50% by the age of 6 years. Most wheezing episodes in preschool children are associated with viral upper respiratory tract infections (episodic viral wheeze). The majority of children with episodic viral wheeze have become asymptomatic by the age of 6 years. About one in three preschool children with recurrent wheeze continue to wheeze after the age of six years, and these children are usually diagnosed with asthma. Two clinical phenotypes of recurrent wheezing in preschool children can be distinguished. Children with episodic viral wheeze only wheeze with viral upper respiratory tract infections and are symptom free in between episodes. A minority of children wheeze during upper respiratory tract infection and with other trigger factors (such as smoke, fog, exercise) and this is defined as multiple trigger wheeze. Inhaled corticosteroids (ICS) have been shown to be effective in preschool children with multiple trigger wheeze, but the effect is smaller than that in older children. This justifies a more critical approach towards such therapy, for example by prescribing a trial of ICS for a period of 3 months and evaluating the effect afterwards. Little research has been performed on the effect of ICS in preschool children with episodic viral wheeze. A high dose of ICS (>1600 ug/d) during an acute episode of dyspnea and wheezing has been shown to be effective, but in a number of small clinical trials maintenance treatment with ICS did not have an effect on the number and severity of episodes of viral wheezing. Contradictory results have been published about the effect of ICS in infants and preschool children with Respiratory Syncytial Virus bronchiolitis. Some studies showed a reduction of wheezing episodes after RSV bronchiolitis in children treated with ICS, two other studies did not show any positive effect. Prescribing ICS in preschool children can result in adverse effects such as a reduced height growth. Because of the lack of evidence of effect of ICS in episodic viral wheeze, guidelines advise a critical approach towards prescribing ICS in episodic viral wheeze.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wheezing, Dyspnea
Keywords
Child, Wheezing, Dyspnea, Inhaled corticosteroids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Beclomethasone
Arm Type
Active Comparator
Arm Description
Inhaled corticosteroids
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Beclomethasone
Other Intervention Name(s)
Qvar
Intervention Description
Beclometasone 100 ug b.i.d. by metered dose inhaler with spacer for 6 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo once a day by metered dose inhaler with spacer for 6 months
Primary Outcome Measure Information:
Title
Number of unscheduled doctor visits for dyspnea and wheezing
Time Frame
One and a half, 3, 6 and 9 months after discharge.
Secondary Outcome Measure Information:
Title
PACQLQ scores and the use of additional asthma medication
Time Frame
One and a half, 3, 6 and 9 months after discharge.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children that are admitted to the paediatric ward of the Isala Klinieken in Zwolle for the first time with acute dyspnea and wheezing Age 1 - 4 years Child and parents must understand the Dutch language well Informed consent Exclusion Criteria: Previous use of medication different than short-acting β2-agonists before hospital admission Proven RSV bronchiolitis Crackles during auscultation of the lungs (suggestive for RSV bronchiolitis)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
N Doornebal, MD
Organizational Affiliation
Princess Amalia Children's Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
J Bekhof, MD
Organizational Affiliation
Princess Amalia Children's Clinic
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
P LP Brand, MDPhD
Organizational Affiliation
Princess Amalia Children's Clinic
Official's Role
Study Director
Facility Information:
Facility Name
Princess Amalia Children's Clinic
City
Zwolle
State/Province
Overijssel
ZIP/Postal Code
8025 AB
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
7800004
Citation
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Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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PubMed Identifier
10796596
Citation
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Citation
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Effectiveness of Inhaled Corticosteroids in Preschool Children With Acute Dyspnea and Wheeze

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