Steroids Helping Albuterol Responders Exclusively (SHARE)

University Hospitals (UH)

Status: Withdrawn

Conditions: Bronchiolitis

Treatments: Drug: placebo; Drug: prednisolone or methylprednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT00798616

UHC 07-08-36

Details and patient eligibility

About

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.

Sex: All

Ages: 4 weeks to 24 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 4 patient groups, including a placebo group

Responders/Placebo

Placebo Comparator group

Description:

Albuterol responders being given placebo

Treatment:

Drug: placebo

Responders/Steroids

Active Comparator group

Description:

albuterol responders being given steroids

Treatment:

Drug: prednisolone or methylprednisolone

Non-responders/placebo

Placebo Comparator group

Description:

non-albuterol responders being given placebo

Treatment:

Drug: placebo

non-responders/steroids

Active Comparator group

Description:

non-albuterol responders being given steroids

Treatment:

Drug: prednisolone or methylprednisolone