AsthmaPhase 4BudERNCT00189436
Effect of Nebulized Budesonide and Oral Corticosteroids on Wheezing Episode Relapse in Children
A Phase 4 study testing Nebulized Budesonide in people with Asthma, run by Deborah Gentile at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 8 years
- Conditions the study is for
- Asthma
- What is being tested?
- Nebulized Budesonide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2003to Jan 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 year to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Bellevue Pediatric Associates
Bellevue, Pennsylvania, 15202
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
About this study
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
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.
Read the detailed description
Secondary outcomes include urinary cortisol-creatinine rations, symptom severity scores and peak flow rates.
- Conditions
- Asthma
- Being tested
- Nebulized Budesonide, Usual care (albuterol with or without oral steroid)
- Keywords
- Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebulized BudesonideDrug
Subject is treated with nebulized budesonide 0.5 BID for 3 weeks
Usual care (albuterol with or without oral steroid)Drug
Subject is treated with usual care as prescribed by the doctor (normally albuterol with or without oral steroid)
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Budesonide | Active comparator | Subject is treated with nebulized budesonide 0.5 BID for 3 weeks Receives: Drug: Nebulized Budesonide |
| Usual care | Active comparator | Subject is treated with usual care as provided by the doctor. Usual care normally consists of treatment with albuterol with or without an oral steroid. Receives: Drug: Usual care (albuterol with or without oral steroid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wheezing/Asthma/Bronchospasm Relapse Rate
This was defined as the percentage of subjects in each group (treatment with budesonide versus usual care) having an unscheduled acute visit to primary care, urgent care or an emergency department during the study period.
Measured: 3 weeks
Secondary outcomes (2)
Urinary Cortisol Levels
This was defined as the mean +/- standard deviation of 12 hour urinary cortisol levels in each group (treatment with budesonide versus usual care).
Measured: 3 weeks
Forced Expiratory Volume in 1 Second (FEV1)
This was defined as the mean +/- standard deviation of FEV1 in each group (treatment with budesonide versus usual care.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startMar 2003
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deborah Gentile
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor-investigator, Deborah Gentile, West Penn Allegheny Health System
- Investigators
- David Skoner, MD, Principal investigator, West Penn Allegheny Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00189436
- Sponsor's protocol ID
- BUD ER 3425
- Other IDs
- RC - 3425
- Acronym
- BudER
- Status last verified
- Jan 2021
- First submitted
- 12 Sep 2005
- Last updated
- 1 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00189436
- Acronym / sponsor ID
- BudER / BUD ER 3425
- Conditions
- Asthma
- Keywords
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Deborah GentileUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Mar 2003
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Posted 4 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Secondary outcomes include urinary cortisol-creatinine rations, symptom severity scores and peak flow rates.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with Budesonide | Active comparator | Drug: Nebulized BudesonideSubject is treated with nebulized budesonide 0.5 BID for 3 weeks |
| Usual care | Active comparator | Drug: Usual care (albuterol with or without oral steroid)Subject is treated with usual care as provided by the doctor. Usual care normally consists of treatment with albuterol with or without an oral steroid. |
Who may qualify
- Ages
- 1 year to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Nebulized BudesonideSubject is treated with nebulized budesonide 0.5 BID for 3 weeks | Drug | Treatment with Budesonide |
| Usual care (albuterol with or without oral steroid)Subject is treated with usual care as prescribed by the doctor (normally albuterol with or without oral steroid) | Drug | Usual care |
Primary outcome
Wheezing/Asthma/Bronchospasm Relapse Rate
Time frame: 3 weeks
This was defined as the percentage of subjects in each group (treatment with budesonide versus usual care) having an unscheduled acute visit to primary care, urgent care or an emergency department during the study period.
2 secondary outcomes
Urinary Cortisol Levels
Time frame: 3 weeks
Forced Expiratory Volume in 1 Second (FEV1)
Time frame: 3 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David Skoner, MD principal investigator
West Penn Allegheny Health System
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nebulized Budesonide in people with Asthma, run by Deborah Gentile at 2 sites 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Wheezing/Asthma/Bronchospasm Relapse Rate (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Feb 2021.