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

This study has been terminated.
(recruitment was unsuccesfull, only 7 patient have been included untill njanuary 2012)
Sponsor:
Information provided by (Responsible Party):
Jolita Bekhof, Princess Amalia Children's Clinic
ClinicalTrials.gov Identifier:
NCT00962299
First received: August 18, 2009
Last updated: January 4, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Wheezing
Dyspnea
Drug: Beclomethasone
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Inhaled Corticosteroids in Preschool Children Following Hospital Admission for Acute Dyspnea and Wheeze

Resource links provided by NLM:


Further study details as provided by Princess Amalia Children's Clinic:

Primary Outcome Measures:
  • Number of unscheduled doctor visits for dyspnea and wheezing [ Time Frame: One and a half, 3, 6 and 9 months after discharge. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • PACQLQ scores and the use of additional asthma medication [ Time Frame: One and a half, 3, 6 and 9 months after discharge. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 62
Study Start Date: May 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Beclomethasone
Inhaled corticosteroids
Drug: Beclomethasone
Beclometasone 100 ug b.i.d. by metered dose inhaler with spacer for 6 months
Other Name: Qvar
Placebo Comparator: Placebo
Placebo Comparator
Drug: Placebo
Placebo once a day by metered dose inhaler with spacer for 6 months
Other Name: Placebo

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.

  Eligibility

Ages Eligible for Study:   1 Year to 4 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00962299

Locations
Netherlands
Princess Amalia Children's Clinic
Zwolle, Overijssel, Netherlands, 8025 AB
Sponsors and Collaborators
Princess Amalia Children's Clinic
Investigators
Principal Investigator: N Doornebal, MD Princess Amalia Children's Clinic
Study Director: J Bekhof, MD Princess Amalia Children's Clinic
Study Director: P LP Brand, MDPhD Princess Amalia Children's Clinic
  More Information

Publications:

Responsible Party: Jolita Bekhof, MD, Pediatrician, Princess Amalia Children's Clinic
ClinicalTrials.gov Identifier: NCT00962299     History of Changes
Other Study ID Numbers: NL26689.075.09
Study First Received: August 18, 2009
Last Updated: January 4, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Princess Amalia Children's Clinic:
Child
Wheezing
Dyspnea
Inhaled corticosteroids

Additional relevant MeSH terms:
Dyspnea
Respiratory Sounds
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Beclomethasone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on April 17, 2014