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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00962299
Recruitment Status : Terminated (recruitment was unsuccesfull, only 7 patient have been included untill 2012)
First Posted : August 19, 2009
Last Update Posted : January 4, 2018
Information provided by (Responsible Party):
Jolita Bekhof, Princess Amalia Children's Clinic

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.

Condition or disease Intervention/treatment Phase
Wheezing Dyspnea Drug: Beclomethasone Drug: Placebo Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Inhaled Corticosteroids in Preschool Children Following Hospital Admission for Acute Dyspnea and Wheeze
Study Start Date : May 2010
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Arm Intervention/treatment
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

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

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

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Ages Eligible for Study:   1 Year to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00962299

Princess Amalia Children's Clinic
Zwolle, Overijssel, Netherlands, 8025 AB
Sponsors and Collaborators
Princess Amalia Children's Clinic
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

Publications of Results:

Responsible Party: Jolita Bekhof, MD, Pediatrician, Princess Amalia Children's Clinic Identifier: NCT00962299     History of Changes
Other Study ID Numbers: NL26689.075.09
First Posted: August 19, 2009    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: January 2018

Keywords provided by Jolita Bekhof, Princess Amalia Children's Clinic:
Inhaled corticosteroids

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