Efficacy of Systemic Glucocorticoid in the Treatment of Wheezing in Children

NCT00494624 | Unknown Phase 4

• 1 other identifier: VINKU
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

We can not predict which wheezing child younger than 3 years of age benefits from systemic glucocorticoid and which one does not. It is not known whether the differences in the efficacy are related to the differences in viral etiology, atopy, immunogical maturity or age of the patient. The study aims to answer the following questions: 1. What is the viral etiology of acute childhood expiratory wheezing? 2. What is the efficacy of prednisolone in relation to age, atopy and viral etiology in acute childhood wheezing? 3. Does prednisolone treatment increase risk for secundary bacterial infection in acute childhood expiratory wheezing? 4. What is the significance of inflammatory markers in predicting the efficacy of systemic steroid or patient outcome in acute childhood expiratory wheezing? Study will follow randomized, double blind, placebo-controlled parallel design. Study will start in Septemper 2000 and will be performed at the Department of Pediatrics, Turku University Hospital, Turku Finland. The study population will be 300 hospitalized wheezing children aged 3 months - 15 years. Investigational drug will be prednisolone, first dose 2 mg/kg, then 2 mg/kg/d/3 (max. 60 mg/vrk) p.o. for 3 d and comparative drug will be placebo tablet similar to investigational drug with the equal dosage. The primary outcome will be the time until ready for discharge. The study will provide new and important information for the diagnostics, treatment, disease outcome and prevention of acute childhood expiratory wheezing.

Conditions

Wheezing

Keywords

Wheezing; virus; child

Outcome Measures

Primary Outcomes (1)

• The time until ready for discharge

Secondary Outcomes (4)

• Oxygen saturation during hospital stay

• Wheeze and cough during two weeks after discharge from the hospital

• Readmission to the out-patient clinic or hospital for recurrent wheezing during a two-month period after discharge

• Blood eosinophil counts at discharge and two weeks later

Interventions

prednisolone DRUG

Eligibility Criteria

• Age: 3 Months - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• age 3 months to 16 years
• hospitalization for expiratory wheezing
• written informed consent from the parents

You may not qualify if:

• Any chronic disease (other than allergy or asthma), e.g. heart disease, immune deficiency, or diabetes
• varicella and exposure to varicella if not previously have had it
• Systemic glucocorticoid 4 weeks prios to the study
• Severe disease that needs treatment in the intensive care unit or oxygen saturation below 92% despite of additional oxygen and frequent salbutamol inhalations

Sponsors & Collaborators

• University of Turku: lead
• Academy of Finland: collaborator

Study Sites (1)

Turku University Hospital

Turku, 20520, Finland

RECRUITING

Related Publications (4)

• Forsstrom V, Toivonen L, Homil K, Waris M, Pedersen CT, Bonnelykke K, Jartti T, Peltola V. Association of Asthma Risk Alleles With Acute Respiratory Tract Infections and Wheezing Illnesses in Young Children. J Infect Dis. 2023 Oct 18;228(8):990-998. doi: 10.1093/infdis/jiad075.

  PMID: 36967681 DERIVED

• Hurme P, Homil K, Lehtinen P, Turunen R, Vahlberg T, Vuorinen T, Camargo CA Jr, Gern JE, Jartti T. Efficacy of inhaled salbutamol with and without prednisolone for first acute rhinovirus-induced wheezing episode. Clin Exp Allergy. 2021 Sep;51(9):1121-1132. doi: 10.1111/cea.13960. Epub 2021 Jun 19.

  PMID: 34062027 DERIVED

• Lukkarinen M, Koistinen A, Turunen R, Lehtinen P, Vuorinen T, Jartti T. Rhinovirus-induced first wheezing episode predicts atopic but not nonatopic asthma at school age. J Allergy Clin Immunol. 2017 Oct;140(4):988-995. doi: 10.1016/j.jaci.2016.12.991. Epub 2017 Mar 25.

  PMID: 28347734 DERIVED

• Lukkarinen M, Lukkarinen H, Lehtinen P, Vuorinen T, Ruuskanen O, Jartti T. Prednisolone reduces recurrent wheezing after first rhinovirus wheeze: a 7-year follow-up. Pediatr Allergy Immunol. 2013 May;24(3):237-43. doi: 10.1111/pai.12046. Epub 2013 Feb 3.

  PMID: 23373881 DERIVED

MeSH Terms

Conditions

Respiratory Sounds; Virus Diseases

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infections

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Tuomas Jartti, MD

  Turku University Hospital

  PRINCIPAL INVESTIGATOR

• Olli Ruuskanen, MD

  Turku University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tuomas Jartti, MD

CONTACT

+358 2 313 0000; tuomas.jartti@utu.fi

Olli Ruuskanen, MD

CONTACT

+358 2 313 0000; olli.ruuskanen@tyks.fi

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 29, 2007
• First Posted: July 2, 2007
• Study Start: September 1, 2000
• Study Completion: May 1, 2008
• Last Updated: July 2, 2007

Record last verified: 2007-06

Locations

FI (1)