NCT00962299

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2010

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 19, 2009

Completed
9 months until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

January 4, 2018

Status Verified

January 1, 2018

Enrollment Period

1.7 years

First QC Date

August 18, 2009

Last Update Submit

January 3, 2018

Conditions

WheezingDyspnea

Keywords

ChildWheezingDyspneaInhaled corticosteroids

Outcome Measures

Primary Outcomes (1)

  • Number of unscheduled doctor visits for dyspnea and wheezing

    One and a half, 3, 6 and 9 months after discharge.

Secondary Outcomes (1)

  • PACQLQ scores and the use of additional asthma medication

    One and a half, 3, 6 and 9 months after discharge.

Study Arms (2)

Beclomethasone

ACTIVE COMPARATOR

Inhaled corticosteroids

Drug: Beclomethasone

Placebo

PLACEBO COMPARATOR

Placebo Comparator

Drug: Placebo

Interventions

BeclomethasoneDRUG

Beclometasone 100 ug b.i.d. by metered dose inhaler with spacer for 6 months

Also known as: Qvar
Beclomethasone
PlaceboDRUG

Placebo once a day by metered dose inhaler with spacer for 6 months

Placebo

Eligibility Criteria

Age1 Year - 4 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Amalia Children's Clinic

Zwolle, Overijssel, 8025 AB, Netherlands

Location

Related Publications (13)

  • 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. doi: 10.1056/NEJM199501193320301.

    PMID: 7800004RESULT

  • Hess J, De Jongste JC. Epidemiological aspects of paediatric asthma. Clin Exp Allergy. 2004 May;34(5):680-5. doi: 10.1111/j.1365-2222.2004.1961.x. No abstract available.

    PMID: 15144456RESULT

  • 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 Souef 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. doi: 10.1183/09031936.00002108.

    PMID: 18827155RESULT

  • Kaditis AG, Winnie G, Syrogiannopoulos GA. Anti-inflammatory pharmacotherapy for wheezing in preschool children. Pediatr Pulmonol. 2007 May;42(5):407-20. doi: 10.1002/ppul.20591.

    PMID: 17358042RESULT

  • McKean M, Ducharme F. Inhaled steroids for episodic viral wheeze of childhood. Cochrane Database Syst Rev. 2000;2000(2):CD001107. doi: 10.1002/14651858.CD001107.

    PMID: 10796596RESULT

  • 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. doi: 10.1001/archpedi.158.2.127.

    PMID: 14757604RESULT

  • 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.

    PMID: 11332164RESULT

  • Kajosaari M, Syvanen P, Forars 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. doi: 10.1034/j.1399-3038.2000.00068.x.

    PMID: 10981531RESULT

  • 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. doi: 10.1001/archpedi.1996.02170300066013.

    PMID: 8620234RESULT

  • 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. doi: 10.1056/NEJMoa051378.

    PMID: 16687711RESULT

  • 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/NEJMoa0808907.

    PMID: 19164187RESULT

  • 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.

    PMID: 15789960RESULT

  • 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. doi: 10.1136/bmj.b897.

    PMID: 19336497RESULT

MeSH Terms

Conditions

Respiratory SoundsDyspnea

Interventions

Beclomethasone

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Chlorinated

Study Officials

  • N Doornebal, MD

    Princess Amalia Children's Clinic

    PRINCIPAL INVESTIGATOR

  • J Bekhof, MD

    Princess Amalia Children's Clinic

    STUDY DIRECTOR

  • P LP Brand, MDPhD

    Princess Amalia Children's Clinic

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Pediatrician

Study Record Dates

First Submitted

August 18, 2009

First Posted

August 19, 2009

Study Start

May 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

January 4, 2018

Record last verified: 2018-01

Locations

NL(1)