BronchiolitisSHARENCT00798616
Steroids Helping Albuterol Responders Exclusively
A study testing prednisolone or methylprednisolone in people with Bronchiolitis, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
The purpose of the study is to determine whether corticosteroids are beneficial to children with bronchiolitis whose breathing gets better after being given a breathing treatment with albuterol. Read more about this study
- Who is it for?
- Ages 4 weeks to 24 months
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- prednisolone or methylprednisolone
- 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
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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 4 weeks to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- diagnosis of bronchiolitis
- Respiratory Distress Assessment Index score of 4 or more
Who cannot join
- prior prescription of bronchodilators or inhaled corticosteroids
- birth at <36 weeks gestation
- chronic cardiac disease
- chronic pulmonary disease (including asthma)
- immunodeficiency
- non-topical steroid use in the prior week
Show all 12Show fewer
- parents that don't understand English
- baseline systolic blood pressure >118 mmHg
- home oxygen use
- evidence of systemic fungal or varicella infection
- bronchodilator use in the prior week
- allergy to albuterol or corticosteroids
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals of Cleveland
Cleveland, Ohio, 44106
About this study
Official title: Are Steroids Efficacious in Hospitalized Patients With Bronchiolitis Who Show an Objective Clinical Improvement After Albuterol ("Albuterol Responders")?
The purpose of the study is to determine whether corticosteroids are beneficial to children with bronchiolitis whose breathing gets better after being given a breathing treatment with albuterol.
- Conditions
- Bronchiolitis
- Being tested
- prednisolone or methylprednisolone, placebo
- Keywords
- bronchiolitis, steroids, corticosteroids, albuterol, child, infant, pediatric
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prednisolone or methylprednisoloneDrug
Also called corticosteroids, Solu-Medrol, Orapred
either prednisolone 2mg/kg PO once daily or methylprednisolone 1.6mg/kg IV once daily (if IV access is present) for length of hospitalization, for a maximum of seven days
placeboDrug
oral or IV placebo
| Study group | Role | What they receive |
|---|---|---|
| Responders/Placebo | Placebo comparator | Albuterol responders being given placebo Receives: Drug: placebo |
| Responders/Steroids | Active comparator | albuterol responders being given steroids Receives: Drug: prednisolone or methylprednisolone |
| Non-responders/placebo | Placebo comparator | non-albuterol responders being given placebo Receives: Drug: placebo |
| non-responders/steroids | Active comparator | non-albuterol responders being given steroids Receives: Drug: prednisolone or methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
respiratory rate and respiratory distress score
Measured: 4 hours
length of hospitalization (actual and until meets "ready for discharge" criteria)
Measured: variable, likely no more than 2 weeks
Secondary outcomes (6)
need for increased respiratory support (intubation, CPAP, BiPAP)
Measured: variable, likely up to 2 weeks
amount of oxygen used during hospitalization
Measured: variable, likely less than 2 weeks
number of doses of bronchodilators used during hospitalization
Measured: variable, likely no more than 2 weeks
total duration of symptoms
Measured: variable, likely no more than 3 weeks
need for unanticipated medical care after discharge
Measured: variable, likely no more than 3 weeks
tachycardia and/or hypertension during hospitalization
Measured: variable, likely no more than 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2008 (estimated)
Why it stopped: We were unable to enroll a sufficient number of patients due to manpower.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Steven L Shein, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00798616
- Sponsor's protocol ID
- UHC 07-08-36
- Acronym
- SHARE
- Status last verified
- Oct 2010
- First submitted
- 25 Nov 2008
- Last updated
- 9 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
American Academy of Pediatrics Subcommittee on Diagnosis and Management of Bronchiolitis. Diagnosis and management of bronchiolitis. Pediatrics. 2006 Oct;118(4):1774-93. doi: 10.1542/peds.2006-2223.
PubMed 17015575Shay DK, Holman RC, Newman RD, Liu LL, Stout JW, Anderson LJ. Bronchiolitis-associated hospitalizations among US children, 1980-1996. JAMA. 1999 Oct 20;282(15):1440-6. doi: 10.1001/jama.282.15.1440.
PubMed 10535434Stang P, Brandenburg N, Carter B. The economic burden of respiratory syncytial virus-associated bronchiolitis hospitalizations. Arch Pediatr Adolesc Med. 2001 Jan;155(1):95-6. doi: 10.1001/archpedi.155.1.95. No abstract available.
PubMed 11177073Wang EE, Law BJ, Boucher FD, Stephens D, Robinson JL, Dobson S, Langley JM, McDonald J, MacDonald NE, Mitchell I. Pediatric Investigators Collaborative Network on Infections in Canada (PICNIC) study of admission and management variation in patients hospitalized with respiratory syncytial viral lower respiratory tract infection. J Pediatr. 1996 Sep;129(3):390-5. doi: 10.1016/s0022-3476(96)70071-9.
PubMed 8804328Schweich PJ, Hurt TL, Walkley EI, Mullen N, Archibald LF. The use of nebulized albuterol in wheezing infants. Pediatr Emerg Care. 1992 Aug;8(4):184-8. doi: 10.1097/00006565-199208000-00003.
PubMed 1513726Kristjansson S, Lodrup Carlsen KC, Wennergren G, Strannegard IL, Carlsen KH. Nebulised racemic adrenaline in the treatment of acute bronchiolitis in infants and toddlers. Arch Dis Child. 1993 Dec;69(6):650-4. doi: 10.1136/adc.69.6.650.
PubMed 8285776Gadomski AM, Bhasale AL. Bronchodilators for bronchiolitis. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD001266. doi: 10.1002/14651858.CD001266.pub2.
PubMed 16855963Dobson JV, Stephens-Groff SM, McMahon SR, Stemmler MM, Brallier SL, Bay C. The use of albuterol in hospitalized infants with bronchiolitis. Pediatrics. 1998 Mar;101(3 Pt 1):361-8. doi: 10.1542/peds.101.3.361.
PubMed 9480998Patel H, Platt R, Lozano JM, Wang EE. Glucocorticoids for acute viral bronchiolitis in infants and young children. Cochrane Database Syst Rev. 2004;(3):CD004878. doi: 10.1002/14651858.CD004878.
PubMed 15266547Garrison MM, Christakis DA, Harvey E, Cummings P, Davis RL. Systemic corticosteroids in infant bronchiolitis: A meta-analysis. Pediatrics. 2000 Apr;105(4):E44. doi: 10.1542/peds.105.4.e44.
PubMed 10742365Kuzik BA, Al-Qadhi SA, Kent S, Flavin MP, Hopman W, Hotte S, Gander S. Nebulized hypertonic saline in the treatment of viral bronchiolitis in infants. J Pediatr. 2007 Sep;151(3):266-70, 270.e1. doi: 10.1016/j.jpeds.2007.04.010. Epub 2007 Jun 29.
PubMed 17719935Leader S, Kohlhase K. Recent trends in severe respiratory syncytial virus (RSV) among US infants, 1997 to 2000. J Pediatr. 2003 Nov;143(5 Suppl):S127-32. doi: 10.1067/s0022-3476(03)00510-9.
PubMed 14615711Rodriguez WJ, Gruber WC, Groothuis JR, Simoes EA, Rosas AJ, Lepow M, Kramer A, Hemming V. Respiratory syncytial virus immune globulin treatment of RSV lower respiratory tract infection in previously healthy children. Pediatrics. 1997 Dec;100(6):937-42. doi: 10.1542/peds.100.6.937.
PubMed 9374560Hartling L, Wiebe N, Russell K, Patel H, Klassen TP. A meta-analysis of randomized controlled trials evaluating the efficacy of epinephrine for the treatment of acute viral bronchiolitis. Arch Pediatr Adolesc Med. 2003 Oct;157(10):957-64. doi: 10.1001/archpedi.157.10.957.
PubMed 14557155Wainwright C, Altamirano L, Cheney M, Cheney J, Barber S, Price D, Moloney S, Kimberley A, Woolfield N, Cadzow S, Fiumara F, Wilson P, Mego S, VandeVelde D, Sanders S, O'Rourke P, Francis P. A multicenter, randomized, double-blind, controlled trial of nebulized epinephrine in infants with acute bronchiolitis. N Engl J Med. 2003 Jul 3;349(1):27-35. doi: 10.1056/NEJMoa022226.
PubMed 12840089
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Steroids Efficacious in Hospitalized Patients With Bronchiolitis Who Show an Objective Clinical Improvement After Albuterol ("Albuterol Responders")?
- ClinicalTrials.gov ID
- NCT00798616
- Acronym / sponsor ID
- SHARE / UHC 07-08-36
- Conditions
- Bronchiolitis
- Keywords
- bronchiolitis, steroids, corticosteroids, albuterol, child, infant, pediatric
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We were unable to enroll a sufficient number of patients due to manpower.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- First posted
- 26 Nov 2008 (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 the study is to determine whether corticosteroids are beneficial to children with bronchiolitis whose breathing gets better after being given a breathing treatment with albuterol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Responders/Placebo | Placebo comparator | Drug: placeboAlbuterol responders being given placebo |
| Responders/Steroids | Active comparator | Drug: prednisolone or methylprednisolonealbuterol responders being given steroids |
| Non-responders/placebo | Placebo comparator | Drug: placebonon-albuterol responders being given placebo |
| non-responders/steroids | Active comparator | Drug: prednisolone or methylprednisolonenon-albuterol responders being given steroids |
Who may qualify
- Ages
- 4 weeks to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- diagnosis of bronchiolitis
- Respiratory Distress Assessment Index score of 4 or more
Key exclusion criteria (12 listed)
- prior prescription of bronchodilators or inhaled corticosteroids
- birth at <36 weeks gestation
- chronic cardiac disease
- chronic pulmonary disease (including asthma)
- immunodeficiency
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 |
|---|---|---|
| prednisolone or methylprednisoloneAlso: corticosteroids, Solu-Medrol, Orapredeither prednisolone 2mg/kg PO once daily or methylprednisolone 1.6mg/kg IV once daily (if IV access is present) for length of hospitalization, for a maximum of seven days | Drug | Responders/Steroids, non-responders/steroids |
| placebooral or IV placebo | Drug | Non-responders/placebo, Responders/Placebo |
Primary outcome
respiratory rate and respiratory distress score
Time frame: 4 hours
length of hospitalization (actual and until meets "ready for discharge" criteria)
Time frame: variable, likely no more than 2 weeks
6 secondary outcomes
need for increased respiratory support (intubation, CPAP, BiPAP)
Time frame: variable, likely up to 2 weeks
amount of oxygen used during hospitalization
Time frame: variable, likely less than 2 weeks
number of doses of bronchodilators used during hospitalization
Time frame: variable, likely no more than 2 weeks
total duration of symptoms
Time frame: variable, likely no more than 3 weeks
need for unanticipated medical care after discharge
Time frame: variable, likely no more than 3 weeks
tachycardia and/or hypertension during hospitalization
Time frame: variable, likely no more than 2 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2014.
- Background: PubMed 17015575American Academy of Pediatrics Subcommittee on Diagnosis and Management of Bronchiolitis. Diagnosis and management of bronchiolitis. Pediatrics. 2006 Oct;118(4):1774-93. doi: 10.1542/peds.2006-2223.
- Background: PubMed 10535434Shay DK, Holman RC, Newman RD, Liu LL, Stout JW, Anderson LJ. Bronchiolitis-associated hospitalizations among US children, 1980-1996. JAMA. 1999 Oct 20;282(15):1440-6. doi: 10.1001/jama.282.15.1440.
- Background: PubMed 11177073Stang P, Brandenburg N, Carter B. The economic burden of respiratory syncytial virus-associated bronchiolitis hospitalizations. Arch Pediatr Adolesc Med. 2001 Jan;155(1):95-6. doi: 10.1001/archpedi.155.1.95. No abstract available.
- Background: PubMed 8804328Wang EE, Law BJ, Boucher FD, Stephens D, Robinson JL, Dobson S, Langley JM, McDonald J, MacDonald NE, Mitchell I. Pediatric Investigators Collaborative Network on Infections in Canada (PICNIC) study of admission and management variation in patients hospitalized with respiratory syncytial viral lower respiratory tract infection. J Pediatr. 1996 Sep;129(3):390-5. doi: 10.1016/s0022-3476(96)70071-9.
- Background: PubMed 1513726Schweich PJ, Hurt TL, Walkley EI, Mullen N, Archibald LF. The use of nebulized albuterol in wheezing infants. Pediatr Emerg Care. 1992 Aug;8(4):184-8. doi: 10.1097/00006565-199208000-00003.
- Background: PubMed 8285776Kristjansson S, Lodrup Carlsen KC, Wennergren G, Strannegard IL, Carlsen KH. Nebulised racemic adrenaline in the treatment of acute bronchiolitis in infants and toddlers. Arch Dis Child. 1993 Dec;69(6):650-4. doi: 10.1136/adc.69.6.650.
- Background: PubMed 16855963Gadomski AM, Bhasale AL. Bronchodilators for bronchiolitis. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD001266. doi: 10.1002/14651858.CD001266.pub2.
- Background: PubMed 9480998Dobson JV, Stephens-Groff SM, McMahon SR, Stemmler MM, Brallier SL, Bay C. The use of albuterol in hospitalized infants with bronchiolitis. Pediatrics. 1998 Mar;101(3 Pt 1):361-8. doi: 10.1542/peds.101.3.361.
- Background: PubMed 15266547Patel H, Platt R, Lozano JM, Wang EE. Glucocorticoids for acute viral bronchiolitis in infants and young children. Cochrane Database Syst Rev. 2004;(3):CD004878. doi: 10.1002/14651858.CD004878.
- Background: PubMed 10742365Garrison MM, Christakis DA, Harvey E, Cummings P, Davis RL. Systemic corticosteroids in infant bronchiolitis: A meta-analysis. Pediatrics. 2000 Apr;105(4):E44. doi: 10.1542/peds.105.4.e44.
- Background: PubMed 17719935Kuzik BA, Al-Qadhi SA, Kent S, Flavin MP, Hopman W, Hotte S, Gander S. Nebulized hypertonic saline in the treatment of viral bronchiolitis in infants. J Pediatr. 2007 Sep;151(3):266-70, 270.e1. doi: 10.1016/j.jpeds.2007.04.010. Epub 2007 Jun 29.
- Background: PubMed 14615711Leader S, Kohlhase K. Recent trends in severe respiratory syncytial virus (RSV) among US infants, 1997 to 2000. J Pediatr. 2003 Nov;143(5 Suppl):S127-32. doi: 10.1067/s0022-3476(03)00510-9.
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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.
Steven L Shein, MD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prednisolone or methylprednisolone in people with Bronchiolitis, run by University Hospitals Cleveland Medical Center at 1 site in United States.
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 2 inclusion and 12 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: withdrawn, as of the sponsor's last update on 9 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
respiratory rate and respiratory distress score (time frame: 4 hours). 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 NCT00798616, which also lists 19 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 9 Dec 2014.