Effectiveness of Inhaled Corticosteroids in Preschool Children With Acute Dyspnea and Wheeze

Dyspnea Clinical Trial

— ICS@ADP  

Official title:

Effectiveness of Inhaled Corticosteroids in Preschool Children Following Hospital Admission for Acute Dyspnea and Wheeze

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00962299
• Other study ID #: NL26689.075.09
• Status: Terminated
• Phase: Phase 4
• First received: August 18, 2009
• Last updated: January 3, 2018
• Start date: May 2010
• Est. completion date: January 2012

Study information

• Verified date: January 2018
• Source: Princess Amalia Children's Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 4 Years

Eligibility

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 ß2-agonists before hospital admission

• Proven RSV bronchiolitis

• Crackles during auscultation of the lungs (suggestive for RSV bronchiolitis)

Related Conditions & MeSH terms

• Dyspnea
• Respiratory Sounds
• Wheezing

Intervention

Drug:
• Beclomethasone
Beclometasone 100 ug b.i.d. by metered dose inhaler with spacer for 6 months
• Placebo
Placebo once a day by metered dose inhaler with spacer for 6 months

Locations

Country	Name	City	State
Netherlands	Princess Amalia Children's Clinic	Zwolle	Overijssel

Sponsors (1)

Lead Sponsor	Collaborator
Princess Amalia Children's Clinic

Country where clinical trial is conducted

Netherlands, 

References & Publications (13)

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, — View Citation

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. doi: 10.1056/N — View Citation

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. B — View Citation

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 corticoster — View Citation

Hess J, De Jongste JC. Epidemiological aspects of paediatric asthma. Clin Exp Allergy. 2004 May;34(5):680-5. Review. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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

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. 200 — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of unscheduled doctor visits for dyspnea and wheezing		One and a half, 3, 6 and 9 months after discharge.
Secondary	PACQLQ scores and the use of additional asthma medication		One and a half, 3, 6 and 9 months after discharge.