Asthma
Conditions
Keywords
fluticasone/propionate salmeterol combination, hospitalization, emergency department, asthma
Brief summary
The objective of this study is to compare readmission to the emergency department for asthma in asthma patients who receive treatment with fluticasone propionate and salmeterol oral inhaler after an initial emergency department visit using a retrospective observational cohort study design.
Interventions
DRUGFluticasone propionate/salmeterol combination ED MD
Receipt of fluticasone propionate/salmeterol combination from the ED physician
DRUGFluticasone propionate/salmeterol combination OP MD
Receipt of fluticasone propionate/salmeterol combination from the OP physician
Sponsors
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with asthma as determined by ICD-9 codes and asthma drug use * at least 12 years of age * discharged from an initial Emergency Department visit within 12 months
Exclusion criteria
* Subjects with COPD or treatment for COPD
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With an Asthma-related Event Occurring Between 1 and 6 Months Following the Index Event | Data were collected during a 4-year period from January 1, 2004 to December 31, 2008. | 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. |
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 6,139 |
| Total | 6,139 |
Baseline characteristics
| Characteristic | Total Population |
|---|---|
| Age, Continuous | 22.36 Years STANDARD_DEVIATION 17.3 |
| Charlson Comorbidity Index Scores | 1.14 scores on a scale STANDARD_DEVIATION 0.57 |
| Sex: Female, Male Female | 3392 Participants |
| Sex: Female, Male Male | 2747 Participants |
| Type of Index Event Emergency Department Visit | 4808 visits |
| Type of Index Event Inpatient hospitalizations | 1331 visits |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Number of Participants With an Asthma-related Event Occurring Between 1 and 6 Months Following the Index Event
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Total Population | Number of Participants With an Asthma-related Event Occurring Between 1 and 6 Months Following the Index Event | 915 participants |
p-value: <0.000195% CI: [1.56, 2.46]Regression, Cox
p-value: <0.000195% CI: [1.42, 2.25]Regression, Cox
p-value: <0.000195% CI: [1.005, 1.011]Regression, Cox