Bronchiolitis, ViralPhase 4NCT02571517
Glucocorticoid Therapy Impact on the Inflammatory Response and Clinical Evolution in Patients With Severe Bronchiolitis
A Phase 4 study testing Glucocorticoids in people with Bronchiolitis, Viral, run by Fundació Sant Joan de Déu.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 12 months
- Conditions the study is for
- Bronchiolitis, Viral
- What is being tested?
- Glucocorticoids
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- No sites listed yet
- Study dates
- Nov 2011to Dec 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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.
About this study
Official title: Impact of the Administration of Systemic Glucocorticoids on Inflammatory Response and Clinical Evolution of Patients Diagnosed With Moderate- Severe Bronchiolitis
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.
Read the 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.
- Conditions
- Bronchiolitis, Viral
- Being tested
- Glucocorticoids, Placebo
- Keywords
- Respiratory viral infection., Respiratory syncytial virus bronchiolitis, METHYLPREDNISOLONE SODIUM SUCCINATE
- Medical subject headings
- Bronchiolitis, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucocorticoidsDrug
Also called SOLU-MODERIN 125 mg, METHYLPREDNISOLONE SODIUM SUCCINATE, ESTILSONA Gotas
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.
PlaceboOther
Also called glucose 5% solution, Plast-Apyr Glucosado 5%
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 14 months
Secondary outcomes (1)
Number of Side effects estimate
Number of Side effects estimate by comparing the experimental group to the control group
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study startNov 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Bronchiolitis, ViralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació Sant Joan de Déu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Iolanda Jordán, MD, Principal investigator, UCIP H Sant Joan de Déu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02571517
- Sponsor's protocol ID
- FSJD-GLUCOBR-2010
- Other IDs
- 2011-000337-36
- Status last verified
- Oct 2015
- First submitted
- 29 Sep 2015
- Last updated
- 8 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 18520973Ogra 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.
PubMed 14980256Harris 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.
PubMed 17908774Bueno 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.
PubMed 18687294Chatham WW, Kimberly RP. Treatment of lupus with corticosteroids. Lupus. 2001;10(3):140-7. doi: 10.1191/096120301675075008.
PubMed 11315342Jat 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.
PubMed 22972138
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Administration of Systemic Glucocorticoids on Inflammatory Response and Clinical Evolution of Patients Diagnosed With Moderate- Severe Bronchiolitis
- ClinicalTrials.gov ID
- NCT02571517
- Acronym / sponsor ID
- FSJD-GLUCOBR-2010
- Conditions
- Bronchiolitis, Viral
- Keywords
- Respiratory viral infection., Respiratory syncytial virus bronchiolitis, METHYLPREDNISOLONE SODIUM SUCCINATE
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Fundació Sant Joan de DéuUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 8 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glucocorticoids | Experimental | Drug: Glucocorticoidsmethylprednisolone 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 |
| Placebo | Placebo comparator | Other: Placebowill 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. |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlucocorticoidsAlso: SOLU-MODERIN 125 mg, METHYLPREDNISOLONE SODIUM SUCCINATE, ESTILSONA GotasPatients 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. | Drug | Glucocorticoids |
| PlaceboAlso: glucose 5% solution, Plast-Apyr Glucosado 5%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 | Placebo |
Primary outcome
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)
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
1 secondary outcome
Number of Side effects estimate
Time frame: 14 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2015.
- Background: PubMed 18520973Bonzel 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.
- Background: PubMed 14980256Ogra 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.
- Background: PubMed 17908774Harris 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.
- Background: PubMed 18687294Bueno 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.
- Background: PubMed 11315342Chatham WW, Kimberly RP. Treatment of lupus with corticosteroids. Lupus. 2001;10(3):140-7. doi: 10.1191/096120301675075008.
- Background: PubMed 22972138Jat 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.
Related trials for Bronchiolitis, Viral
Recruiting
Respiratory Physiotherapy and Hospitalization in Infants With Bronchiolitis
Acute Viral Bronchiolitis
Not yet recruitingObservational study
Internal Jugular Vein Respiratory Variability as a Marker of Disease Severity in Infant Bronchiolitis
Acute Bronchiolitis, Viral Bronchiolitis
Active, not recruitingObservational study
Effectiveness of Immunization in Preventing Severe Acute Respiratory Infection RSV in Children Under 6 Months in Bogotá
Respiratory Syncytial Virus Infections, Severe Acute Respiratory Infection
Not yet recruitingObservational study
Gut Microbiome and Immune Response in Severe RSV Infection in Vietnamese Infants
Respiratory Syncytial Virus Infection, Bronchiolitis
Active, not recruiting
Eliminating Monitor Overuse Trial (EMO Trial)
Bronchiolitis Acute Viral
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iolanda Jordán, MD principal investigator
UCIP H Sant Joan de Déu
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Glucocorticoids in people with Bronchiolitis, Viral, run by Fundació Sant Joan de Déu.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in inflammatory response (time frame: enrollment to one week treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02571517, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2015; AzTrials last refreshed its copy on 6 Nov 2026.