Steroids Helping Albuterol Responders Exclusively (SHARE)

December 5, 2014 updated by: University Hospitals Cleveland Medical Center

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals of Cleveland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 weeks to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diagnosis of bronchiolitis
  • Respiratory Distress Assessment Index score of 4 or more

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Responders/Placebo
Albuterol responders being given placebo
Drug: placebo
oral or IV placebo
Active Comparator: Responders/Steroids
albuterol responders being given steroids
Drug: prednisolone or methylprednisolone
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
Other Names:
  • Solu-Medrol
  • corticosteroids
  • Orapred
Placebo Comparator: Non-responders/placebo
non-albuterol responders being given placebo
Drug: placebo
oral or IV placebo
Active Comparator: non-responders/steroids
non-albuterol responders being given steroids
Drug: prednisolone or methylprednisolone
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
Other Names:
  • Solu-Medrol
  • corticosteroids
  • Orapred

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
respiratory rate and respiratory distress score
Time Frame: 4 hours
4 hours
length of hospitalization (actual and until meets "ready for discharge" criteria)
Time Frame: variable, likely no more than 2 weeks
variable, likely no more than 2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
need for increased respiratory support (intubation, CPAP, BiPAP)
Time Frame: variable, likely up to 2 weeks
variable, likely up to 2 weeks
amount of oxygen used during hospitalization
Time Frame: variable, likely less than 2 weeks
variable, likely less than 2 weeks
number of doses of bronchodilators used during hospitalization
Time Frame: variable, likely no more than 2 weeks
variable, likely no more than 2 weeks
total duration of symptoms
Time Frame: variable, likely no more than 3 weeks
variable, likely no more than 3 weeks
need for unanticipated medical care after discharge
Time Frame: variable, likely no more than 3 weeks
variable, likely no more than 3 weeks
tachycardia and/or hypertension during hospitalization
Time Frame: variable, likely no more than 2 weeks
variable, likely no more than 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Cleveland Medical Center

Investigators

  • Principal Investigator: Steven L Shein, MD, University Hospitals Cleveland Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 25, 2008

First Submitted That Met QC Criteria

November 25, 2008

First Posted (Estimate)

November 26, 2008

Study Record Updates

Last Update Posted (Estimate)

December 9, 2014

Last Update Submitted That Met QC Criteria

December 5, 2014

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHC 07-08-36

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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