Trial Outcomes & Findings for Use of Fluticasone Propionate/Salmeterol Combination Post Emergency Department Visit (NCT NCT01332357)
NCT ID: NCT01332357
Last Updated: 2017-07-06
Results Overview
A subsequent asthma-related inpatient (IP) visit or emergency department (ED) visit were defined as visits within 6 months of the index event. The index event was defined as an asthma-related hospitalization or ED visit occuring between 2004 and 2008.
COMPLETED
6139 participants
Data were collected during a 4-year period from January 1, 2004 to December 31, 2008.
2017-07-06
Participant Flow
Participants were not recruited for, nor enrolled in, this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymized and used to develop a cohort. All diagnoses and treatments are recorded in the course of routine medical practice.
Participant milestones
| Measure |
Total Population
Adult and pediatric participants with persistent asthma were identified from commercially-insured and Medicaid health plan members with both medical and pharmacy benefits who had data in one of two healthcare claims databases.
|
|---|---|
|
Overall Study
STARTED
|
6139
|
|
Overall Study
COMPLETED
|
6139
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of Fluticasone Propionate/Salmeterol Combination Post Emergency Department Visit
Baseline characteristics by cohort
| Measure |
Total Population
n=6139 Participants
Adult and pediatric participants with persistent asthma were identified from commercially-insured and Medicaid health plan members with both medical and pharmacy benefits who had data in one of two healthcare claims databases.
|
|---|---|
|
Age, Continuous
|
22.36 Years
STANDARD_DEVIATION 17.30 • n=93 Participants
|
|
Sex: Female, Male
Female
|
3392 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
2747 Participants
n=93 Participants
|
|
Type of Index Event
Inpatient hospitalizations
|
1331 visits
n=93 Participants
|
|
Type of Index Event
Emergency Department Visit
|
4808 visits
n=93 Participants
|
|
Charlson Comorbidity Index Scores
|
1.14 scores on a scale
STANDARD_DEVIATION 0.57 • n=93 Participants
|
PRIMARY outcome
Timeframe: Data were collected during a 4-year period from January 1, 2004 to December 31, 2008.Population: Adult and pediatric participants with persistent asthma were identified from commercially-insured and Medicaid health plan members with both medical and pharmacy benefits who had data in one of two healthcare claims databases.
A subsequent asthma-related inpatient (IP) visit or emergency department (ED) visit were defined as visits within 6 months of the index event. The index event was defined as an asthma-related hospitalization or ED visit occuring between 2004 and 2008.
Outcome measures
| Measure |
Total Population
n=6139 Participants
Adult and pediatric participants with persistent asthma were identified from commercially-insured and Medicaid health plan members with both medical and pharmacy benefits who had data in one of two healthcare claims databases.
|
|---|---|
|
Number of Participants With an Asthma-related Event Occurring Between 1 and 6 Months Following the Index Event
|
915 participants
|
Adverse Events
Total Population
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER