Trial Outcomes & Findings for Effect of Nebulized Budesonide and Oral Corticosteroids on Wheezing Episode Relapse in Children (NCT NCT00189436)
NCT ID: NCT00189436
Last Updated: 2021-02-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
61 participants
Primary outcome timeframe
3 weeks
Results posted on
2021-02-01
Participant Flow
Participant milestones
| Measure |
Treatment With Budesonide
Subject is treated with nebulized budesonide 0.5 BID for 3 weeks
Nebulized Budesonide: Subject is treated with nebulized budesonide 0.5 BID for 3 weeks
|
Usual Care
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.
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)
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
30
|
|
Overall Study
COMPLETED
|
23
|
25
|
|
Overall Study
NOT COMPLETED
|
8
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Nebulized Budesonide and Oral Corticosteroids on Wheezing Episode Relapse in Children
Baseline characteristics by cohort
| Measure |
Treatment With Budesonide
n=31 Participants
Subject is treated with nebulized budesonide 0.5 BID for 3 weeks
Nebulized Budesonide: Subject is treated with nebulized budesonide 0.5 BID for 3 weeks
|
Usual Care
n=30 Participants
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.
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)
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
4.8 years
STANDARD_DEVIATION 2.0 • n=5 Participants
|
5.4 years
STANDARD_DEVIATION 1.6 • n=7 Participants
|
5.1 years
STANDARD_DEVIATION 0.084 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 weeksThis 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.
Outcome measures
| Measure |
Treatment With Budesonide
n=23 Participants
Subject is treated with nebulized budesonide 0.5 BID for 3 weeks
Nebulized Budesonide: Subject is treated with nebulized budesonide 0.5 BID for 3 weeks
|
Usual Care
n=25 Participants
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.
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)
|
|---|---|---|
|
Wheezing/Asthma/Bronchospasm Relapse Rate
|
8.7 percentage of cases of asthma relapse
|
4.0 percentage of cases of asthma relapse
|
SECONDARY outcome
Timeframe: 3 weeksThis was defined as the mean +/- standard deviation of 12 hour urinary cortisol levels in each group (treatment with budesonide versus usual care).
Outcome measures
| Measure |
Treatment With Budesonide
n=23 Participants
Subject is treated with nebulized budesonide 0.5 BID for 3 weeks
Nebulized Budesonide: Subject is treated with nebulized budesonide 0.5 BID for 3 weeks
|
Usual Care
n=25 Participants
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.
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)
|
|---|---|---|
|
Urinary Cortisol Levels
|
95.4 ng cortisol/mg creatinine
Standard Deviation 35.3
|
141.6 ng cortisol/mg creatinine
Standard Deviation 42.7
|
SECONDARY outcome
Timeframe: 3 weeksThis was defined as the mean +/- standard deviation of FEV1 in each group (treatment with budesonide versus usual care.
Outcome measures
| Measure |
Treatment With Budesonide
n=23 Participants
Subject is treated with nebulized budesonide 0.5 BID for 3 weeks
Nebulized Budesonide: Subject is treated with nebulized budesonide 0.5 BID for 3 weeks
|
Usual Care
n=25 Participants
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.
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)
|
|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1)
|
86.2 % Predicted
Standard Deviation 2.5
|
85.7 % Predicted
Standard Deviation 3.1
|
Adverse Events
Treatment With Budesonide
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
David Skoner, MD
Allegheny Singer Research Institute, WPAHS
Phone: 412-359-4099
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place