- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02571517
Glucocorticoid Therapy Impact on the Inflammatory Response and Clinical Evolution in Patients With Severe Bronchiolitis
Impact of the Administration of Systemic Glucocorticoids on Inflammatory Response and Clinical Evolution of Patients Diagnosed With Moderate- Severe Bronchiolitis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A Prospective, randomised, double blind and placebo controlled study. Patients assigned to experimental group (group 1) will receive iv methylprednisolone 2 mg/kg/day (in two divided doses) and/or oral prednisolone 2,5 mg/kg/day (in two divided doses) every 12 hours, during 7 days.
Patients assigned to control group (group 2) will receive iv/oral glucose 5% solution as placebo, at the same dose and time as the experimental group. A total of 50 (initially 39, but it was extended to 50 by Protocol Amendment) patients per group are recruited.
Bronchiolitis is the most common infection of the lower respiratory tract. It is defined as, the first episode of bronchospasm, dyspnea, expiratory difficulty, feed refusal, tachypnea greater than 50 rpm and radiological evidence of hyperinflation, in less than 24 months.
It is a very prevalent disease, Respiratory syncytial virus (RSV) infects 70% of children under one year and 100% of children under 2 years and generates a major health impact on epidemic period (especially from December to February) . It is the most frequent cause of hospitalization in children under one year during the winter and up to 10% of those admitted will need intensive care, of which up to 60% required intubation and mechanical ventilation. The estimated disease in healthy children, mortality ranges from 0.005% to 0.02%, while in hospitalized children becomes between 1% and 3%.
In recent years, there have been numerous studies, mainly in RSV bronchiolitis, to analyze the immunological basis of the disease, as discussed complex, in order to perform a prophylaxis and treatment of more optimal infection.
Inflammatory response in bronchiolitis results in activation of cytokines and chemokines that generates a viral clearance. However, if the inflammatory response is disproportionate, the pathogenesis of the disease can lead to a worse clinical evolution.
Corticosteroids are drugs having inhibitory effects on specific immune response, mediated both T cells and the B cell, and are potent inhibitors of phagocyte function. These drugs are effective in the management of multiple forms of secondary inflammatory diseases or immune disorders and may also be useful in the management of bronchiolitis.
The treatment of bronchiolitis is mainly based on supportive therapy: oxygen therapy, proper hydration and aspiration of nasal secretions. Many treatments have been tried that have tried to lessen the severity of the infection, such as the use of bronchodilators and / or corticosteroids, although with controversial results.
In the literature review conducted in PubMed, the investigators found about 110 related bronchiolitis, as MeSH Terms, publications using the words "bronchiolitis" [All Fields] AND ("child" [MeSH Terms].
Only three of these articles shows results of clinical trials, although none in relation to the usefulness of steroids in bronchiolitis.
There is just a case report describing the use of intravenous corticosteroids in infants with severe bronchiolitis, in combination with therapies such as extracorporeal oxygenation.
One of the important aspects that the investigators took in consideration is that rhinovirus bronchiolitis is one of the most involved cause in the development of asthma, and just one of the etiologies of bronchiolitis who could benefit from treatment with corticosteroids.
Prednisolone and methylprednisolone are also well known and used drugs, whose side effects are often dose and duration dependent.
The identification and recruitment of patients will take place during the admission in the Intensive Pediatric Unit Care unit at the Hospital Sant Joan de Deu.
Treatment of patients starts on days 0 and 3 of hospitalization. The patient treatment duration is 7 days, after that starts the follow-up phase, which duration is one month from the date of the baseline visit and until the hospital discharge.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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)
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Glucocorticoids
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 |
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.
Other Names:
|
Placebo Comparator: Placebo
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. |
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in inflammatory response
Time Frame: enrollment to one week treatment
|
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
Time Frame: 14 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Side effects estimate
Time Frame: 14 months
|
Number of Side effects estimate by comparing the experimental group to the control group
|
14 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Iolanda Jordán, MD, UCIP H Sant Joan de Déu
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- Chatham WW, Kimberly RP. Treatment of lupus with corticosteroids. Lupus. 2001;10(3):140-7. doi: 10.1191/096120301675075008.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Bronchial Diseases
- Lung Diseases, Obstructive
- Bronchitis
- Bronchiolitis
- Bronchiolitis, Viral
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Neuroprotective Agents
- Protective Agents
- Prednisolone
- Methylprednisolone Acetate
- Methylprednisolone
- Methylprednisolone Hemisuccinate
- Prednisolone acetate
- Prednisolone hemisuccinate
- Prednisolone phosphate
- Glucocorticoids
Other Study ID Numbers
- FSJD-GLUCOBR-2010
- 2011-000337-36 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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