Effectiveness of Inhaled Corticosteroids in Preschool Children With Acute Dyspnea and Wheeze - Full Text View

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:

MedlinePlus related topics: Breathing Problems Steroids Toddler Health

Drug Information available for: Beclomethasone dipropionate Beclomethasone dipropionate monohydrate

U.S. FDA Resources

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:

Martinez FD, Wright AL, Taussig LM, Holberg CJ, Halonen M, Morgan WJ. Asthma and wheezing in the first six years of life. The Group Health Medical Associates. N Engl J Med. 1995 Jan 19;332(3):133-8.

Hess J, De Jongste JC. Epidemiological aspects of paediatric asthma. Clin Exp Allergy. 2004 May;34(5):680-5. Review. No abstract available.

Brand PL, Baraldi E, Bisgaard H, Boner AL, Castro-Rodriguez JA, Custovic A, de Blic J, de Jongste JC, Eber E, Everard ML, Frey U, Gappa M, Garcia-Marcos L, Grigg J, Lenney W, Le Souëf P, McKenzie S, Merkus PJ, Midulla F, Paton JY, Piacentini G, Pohunek P, Rossi GA, Seddon P, Silverman M, Sly PD, Stick S, Valiulis A, van Aalderen WM, Wildhaber JH, Wennergren G, Wilson N, Zivkovic Z, Bush A. Definition, assessment and treatment of wheezing disorders in preschool children: an evidence-based approach. Eur Respir J. 2008 Oct;32(4):1096-110. Review.

Kaditis AG, Winnie G, Syrogiannopoulos GA. Anti-inflammatory pharmacotherapy for wheezing in preschool children. Pediatr Pulmonol. 2007 May;42(5):407-20. Review.

McKean M, Ducharme F. Inhaled steroids for episodic viral wheeze of childhood. Cochrane Database Syst Rev. 2000;(2):CD001107. Review.

King VJ, Viswanathan M, Bordley WC, Jackman AM, Sutton SF, Lohr KN, Carey TS. Pharmacologic treatment of bronchiolitis in infants and children: a systematic review. Arch Pediatr Adolesc Med. 2004 Feb;158(2):127-37. Review.

Hesselmar B, Adolfsson S. Inhalation of corticosteroids after hospital care for respiratory syncytial virus infection diminishes development of asthma in infants. Acta Paediatr. 2001 Mar;90(3):260-3.

Kajosaari M, Syvänen P, Förars M, Juntunen-Backman K. Inhaled corticosteroids during and after respiratory syncytial virus-bronchiolitis may decrease subsequent asthma. Pediatr Allergy Immunol. 2000 Aug;11(3):198-202.

Reijonen T, Korppi M, Kuikka L, Remes K. Anti-inflammatory therapy reduces wheezing after bronchiolitis. Arch Pediatr Adolesc Med. 1996 May;150(5):512-7.

Guilbert TW, Morgan WJ, Zeiger RS, Mauger DT, Boehmer SJ, Szefler SJ, Bacharier LB, Lemanske RF Jr, Strunk RC, Allen DB, Bloomberg GR, Heldt G, Krawiec M, Larsen G, Liu AH, Chinchilli VM, Sorkness CA, Taussig LM, Martinez FD. Long-term inhaled corticosteroids in preschool children at high risk for asthma. N Engl J Med. 2006 May 11;354(19):1985-97.

Ducharme FM, Lemire C, Noya FJ, Davis GM, Alos N, Leblond H, Savdie C, Collet JP, Khomenko L, Rivard G, Platt RW. Preemptive use of high-dose fluticasone for virus-induced wheezing in young children. N Engl J Med. 2009 Jan 22;360(4):339-53.

Raat H, Bueving HJ, de Jongste JC, Grol MH, Juniper EF, van der Wouden JC. Responsiveness, longitudinal- and cross-sectional construct validity of the Pediatric Asthma Quality of Life Questionnaire (PAQLQ) in Dutch children with asthma. Qual Life Res. 2005 Feb;14(1):265-72.

Ermers MJ, Rovers MM, van Woensel JB, Kimpen JL, Bont LJ; RSV Corticosteroid Study Group. The effect of high dose inhaled corticosteroids on wheeze in infants after respiratory syncytial virus infection: randomised double blind placebo controlled trial. BMJ. 2009 Mar 31;338:b897.

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 June 17, 2013

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