![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
Tracking Information | |||||||||
---|---|---|---|---|---|---|---|---|---|
First Received Date † | October 25, 2006 | ||||||||
Last Updated Date | April 28, 2008 | ||||||||
Start Date † | December 2006 | ||||||||
Current Primary Outcome Measures † |
Median asthma score at 2 hours. [ Time Frame: 2 hours ] [ Designated as safety issue: No ] | ||||||||
Original Primary Outcome Measures † | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT00393367 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures † |
|
||||||||
Original Secondary Outcome Measures † |
|
||||||||
Descriptive Information | |||||||||
Brief Title † | Budesonide Inhalation Suspension for Acute Asthma in Children | ||||||||
Official Title † | Budesonide Inhalation Suspension for Acute Asthma in Children | ||||||||
Brief Summary | The purpose of this study is to determine whether the addition of budesonide inhalation suspension (BIS) to the standard therapy of albuterol, ipratropium bromide, and systemic corticosteroids (SCS) for moderate to severe asthma flares in children reduces asthma severity more rapidly than standard therapy alone. |
||||||||
Detailed Description | Context: Acute asthma is a leading cause of emergency department (ED) visits and hospitalizations. Although standard therapy for acute asthma includes systemic corticosteroids (SCS), these drugs take many hours to have an effect. Recent studies demonstrate that inhaled corticosteroids (ICS) may improve patients' asthma severity more rapidly than SCS and may decrease hospitalizations. Only a few small studies have evaluated ICS added to standard therapy for acute asthma in children. Objective: To determine if adding the nebulized steroid budesonide to standard therapy including SCS improves patients' asthma severity faster than standard therapy alone and leads to fewer hospitalizations. Study Design/Setting/Participants: A double-blind, randomized, controlled trial of budesonide inhalation suspension (BIS) versus placebo for children 2 to 18 years of age who present to a tertiary care, urban pediatric ED with a moderate to severe asthma flare. Intervention: Participants will receive standard therapy including SCS, albuterol, and ipratropium bromide and will be randomly assigned to also receive either nebulized BIS or saline. Study Measures: Differences in asthma scores, vital signs, and the need for hospitalization will be compared between treatment groups. |
||||||||
Study Phase | Phase IV | ||||||||
Study Type † | Interventional | ||||||||
Study Design † | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study | ||||||||
Condition † |
|
||||||||
Intervention † | Drug: Budesonide inhalation suspension (0.5 mg/2mL) | ||||||||
Study Arms / Comparison Groups | Placebo Comparator: standardized treatment with nebulized BIS versus standardized treatment with nebulized saline | ||||||||
Publications * |
|
||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||||||
Recruitment Information | |||||||||
Recruitment Status † | Completed | ||||||||
Enrollment † | 180 | ||||||||
Completion Date | November 2007 | ||||||||
Primary Completion Date | November 2007 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
Gender | Both | ||||||||
Ages | 2 Years to 18 Years | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts †† | |||||||||
Location Countries † | United States | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00393367 | ||||||||
Responsible Party | Cynthia J. Mollen, MD, Children's Hospital of Philadelphia | ||||||||
Secondary IDs †† | |||||||||
Study Sponsor † | Children's Hospital of Philadelphia | ||||||||
Collaborators †† | |||||||||
Investigators † |
|
||||||||
Information Provided By | Children's Hospital of Philadelphia | ||||||||
Verification Date | April 2008 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |