Evaluate the Effect of Nebulized Budesonide and Oral Corticosteroids on Wheezing Episode Relapse in Children Following Discharge From the ER/Outpatient Care Facility
Information source: Allegheny General Hospital
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Nebulized Budesonide (Drug); Usual care (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Allegheny General Hospital Official(s) and/or principal investigator(s):
David Skoner, MD, Principal Investigator, Affiliation: Allegheny General Hospital
Overall contact:
Jennifer Koehrsen, MS, CCRC, Phone: 412-359-6988, Email: jkoehrse@wpahs.org
Summary
Subjects aged 1-8 years who have been discharged from the emergency department/outpatient
care facility with a diagnosis of asthma/bronchospasm/wheezing after usual standard care will
be enrolled into this open-label, randomized, parallel-group study to compare the efficacy of
nebulized budesonide and oral corticosteroids in preventing asthma exacerbation relapse rates
during the 21-day follow-up period. Secondary outcomes include urinary cortisol-creatinine
rations, symptom severity scores and peak flow rates.
Clinical Details
Official title: A Pilot Study to Evaluate the Effect of Nebulized Budesonide and Oral Corticosteroids on Wheezing Episode Relapse in Pediatric Patients Following Discharge From the Emergency Department/Outpatient Care Facility
Study design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Wheezing/Asthma/Bronchospasm relapse rate
Secondary outcome: Urinary CortisolSpirometry readings
Eligibility
Minimum age: 1 Year.
Maximum age: 8 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Children ages 1-8 years old
- Discharge from emergency department/outpatient clinic with a diagnosis of asthma
exacerbation after usual standard care
- Subjects must be able to show efficient use with a jet nebulizer
Exclusion Criteria:
- Subjects requiring hospitalization
- Subjects receiving oral steroids 1 week prior to presentation to emergency
department.
- Subjects with FEV1 < 50% of predicted
- Subjects with co-morbid medical conditions (renal or cardiovascular disease)
- Subjects with reported history of HIV
- Subjects unable to follow up for study visits
- Subjects who are frequently enuretic
Locations and Contacts
Jennifer Koehrsen, MS, CCRC, Phone: 412-359-6988, Email: jkoehrse@wpahs.org
Allegheny General Hospital, Pittsburgh, Pennsylvania 15212, United States; Recruiting
Jennifer Koehrsen, MS, Phone: 412-359-6988, Email: jkoehrse@wpahs.org
David Skoner, MD, Principal Investigator
Bellevue Pediatric Associates, Bellevue, Pennsylvania 15202, United States; Recruiting
Timothy Kesslar, Phone: 412-761-1190, Email: tkesslar@wpahs.org
Gregory Hoyson, MD, Sub-Investigator
Additional Information
Starting date: March 2003
Ending date: December 2010
Last updated: October 23, 2008
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