Glucocorticoid Therapy Impact on the Inflammatory Response and Clinical Evolution in Patients With Severe Bronchiolitis

NCT02571517 | Completed Phase 4

• 2 other identifiers: FSJD-GLUCOBR-20102011-000337-36
• Study Type: interventional
• Target: 94
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to to demonstrate that a 7-day course of systemic glucocorticoids decreases the inflammatory activity of moderate or severe bronchiolitis in paediatric patients compared to the standard treatment. To evaluate the morbidity (regarding to the clinical course: Intensive Pediatric Unit Care unit (PICU) admission, mechanical ventilation, ionotropic support, nosocomial infection, rescue therapy for respiratory failure; duration of PICU stay and hospitalization; and exitus) between the treatment and the control groups.

Conditions

Bronchiolitis, Viral

Keywords

Respiratory viral infection.; Respiratory syncytial virus bronchiolitis; METHYLPREDNISOLONE SODIUM SUCCINATE

Outcome Measures

Primary Outcomes (2)

• Change from Baseline in inflammatory response

  inflammatory response evaluation of the first week of glucocorticoids treatment as assessed by multiple measurements aggregated to arrive at one reported value, which are: the bronchiolitis clinical severity Scale, pediatric mortality Risk scale (PRISM III), the Chest x-ray test, the nasopharyngeal aspiration and analytical exploration (at day 5-7)

  enrollment to one week treatment

• Morbidity episodes

  Morbidity assessment by multiple measurements aggregated to arrive at one reported value which are as follow: necessity of mechanical ventilation, inotropic, presence of nosocomial infection, rescue therapies if respiratory failure occur; days of admission to the Pediatric Intensive Care Unit and hospitalization, in both treatment and control groups

  14 months

Secondary Outcomes (1)

• Number of Side effects estimate

  14 months

Study Arms (2)

Glucocorticoids

EXPERIMENTAL

methylprednisolone intravenous administration of 2mg/kg/day (divided in two doses) and/or oral prednisolone 2,5 mg/kg/day (in two divided doses) during 7 days. Patients younger than 2 year, who required hospitalization, affected by moderate or severe bronchiolitis

Drug: Glucocorticoids

Placebo

PLACEBO COMPARATOR

will receive iv/oral glucose 5% solution as placebo of 2mg/kg/day and/or 2,5 mg/kg/day (divided in two doses) during 7 days. Patients younger than 2 year, who required hospitalization, affected by moderate or severe bronchiolitis.

Other: Placebo

Interventions

Glucocorticoids DRUG

Patients assigned to experimental group (group 1) will receive iv methylprednisolone 2 mg/kg/day (divided in two doses) doses and/or oral prednisolone 2,5 mg/kg/day (divided in two doses) during 7 days.

Also known as: SOLU-MODERIN 125 mg, METHYLPREDNISOLONE SODIUM SUCCINATE, ESTILSONA Gotas

Glucocorticoids

Placebo OTHER

Patients assigned to control group (group 2) will receive iv/oral glucose 5% solution as placebo, 2 mg/kg/day (divided in two doses) during 7 days.

Also known as: glucose 5% solution, Plast-Apyr Glucosado 5%

Placebo

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The study will recruit paediatric patients younger than one year old who require hospitalization for moderate-severe bronchiolitis according to the BRONCHIOLITIS SCORE of Sant Joan de Deu Hospital (HSJD)

You may not qualify if:

• Patients of either gender under one year old with mild bronchiolitis.
• Patients with bronchiolitis in which the principal symptom is apnoea.
• Patients who have received corticotherapy before admission to hospital.
• No consent from parents or tutors.
• Patients with previous acquired or innate immunodepression.
• Patients enrolled in other clinical trials.

Sponsors & Collaborators

• Fundació Sant Joan de Déu: lead

Related Publications (6)

• Bonzel L, Tenenbaum T, Schroten H, Schildgen O, Schweitzer-Krantz S, Adams O. Frequent detection of viral coinfection in children hospitalized with acute respiratory tract infection using a real-time polymerase chain reaction. Pediatr Infect Dis J. 2008 Jul;27(7):589-94. doi: 10.1097/INF.0b013e3181694fb9.

  PMID: 18520973 BACKGROUND

• Ogra PL. Respiratory syncytial virus: the virus, the disease and the immune response. Paediatr Respir Rev. 2004;5 Suppl A:S119-26. doi: 10.1016/s1526-0542(04)90023-1.

  PMID: 14980256 BACKGROUND

• Harris JA, Huskins WC, Langley JM, Siegel JD; Pediatric Special Interest Group of the Society for Healthcare Epidemiology of America. Health care epidemiology perspective on the October 2006 recommendations of the Subcommittee on Diagnosis and Management of Bronchiolitis. Pediatrics. 2007 Oct;120(4):890-2. doi: 10.1542/peds.2007-1305. No abstract available.

  PMID: 17908774 BACKGROUND

• Bueno SM, Gonzalez PA, Pacheco R, Leiva ED, Cautivo KM, Tobar HE, Mora JE, Prado CE, Zuniga JP, Jimenez J, Riedel CA, Kalergis AM. Host immunity during RSV pathogenesis. Int Immunopharmacol. 2008 Oct;8(10):1320-9. doi: 10.1016/j.intimp.2008.03.012. Epub 2008 Apr 14.

  PMID: 18687294 BACKGROUND

• Chatham WW, Kimberly RP. Treatment of lupus with corticosteroids. Lupus. 2001;10(3):140-7. doi: 10.1191/096120301675075008.

  PMID: 11315342 BACKGROUND

• Jat KR, Chawla D. Surfactant therapy for bronchiolitis in critically ill infants. Cochrane Database Syst Rev. 2012 Sep 12;(9):CD009194. doi: 10.1002/14651858.CD009194.pub2.

  PMID: 22972138 BACKGROUND

MeSH Terms

Conditions

Bronchiolitis, Viral

Interventions

Glucocorticoids; Methylprednisolone; Methylprednisolone Hemisuccinate; Glucose; Solutions

Condition Hierarchy (Ancestors)

Bronchiolitis; Bronchitis; Respiratory Tract Infections; Infections; Virus Diseases; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Hexoses; Monosaccharides; Sugars; Carbohydrates; Pharmaceutical Preparations

Study Officials

• Iolanda Jordán, MD

  UCIP H Sant Joan de Déu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2015
• First Posted: October 8, 2015
• Study Start: November 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 8, 2015

Record last verified: 2015-10