Asthma
Conditions
Keywords
pediatrics, Medicaid, asthma, outcomes, asthma medication ratio
Brief summary
The purpose of this study is to assess the predictive ability of three asthma risk markers: the ratio of controller medication to total asthma medication, an albuterol only marker, and an oral corticosteroid use marker, as well as to compare the precision of these tools between adult and pediatric patient populations. This retrospective longitudinal analysis will use 2 different databases: a large managed care database and a large fee for service Medicaid database.
Interventions
participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol.
Sponsors
Study design
Eligibility
Inclusion criteria
* Subjects with asthma as determined by ICD-9 codes and asthma drug use * at least 4 years of age * use of at least 1 controller or at least 5 albuterol prescriptions in 12 months
Exclusion criteria
* Subjects with COPD or treatment for COPD
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Ratio of Controller Medication to Total Asthma Medication | January 1, 2004 to June 30, 2006: 3, 6, and 12 month follow-up periods | The ratio of controller medication (CM) to total asthma medication (AM), which is well established in predicting future asthma events in adults, was calculated as the ratio of the units of CMs used during the defined period divided by the sum of the units of CMs plus the units of inhaled short-acting beta-agonists used during the same period. A CM is defined as any inhaled corticosteroid containing medication, methylxanthines, leukotriene receptor antagonists, or cromolyn sodium. The ratio is calculated using all CM. Asthma controllers are medications used to treat asthma on a regular basis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Number of Short-acting Beta-agonist (SABA) Canisters Used | January 1, 2004 to June 30, 2006: 3, 6, and 12 month follow-up periods | The number of albuterol canisters dispensed is a marker that is well established in predicting future asthma events in an adult population. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pediatric Participants Diagnosed With Asthma Pediatric (4-17 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known. | 41,753 |
| Adult Participants Diagnosed With Asthma Adult (\>=18 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known. | 59,684 |
| Total | 101,437 |
Baseline characteristics
| Characteristic | Pediatric Participants Diagnosed With Asthma | Adult Participants Diagnosed With Asthma | Total |
|---|---|---|---|
| Age, Continuous | 10.1 Years STANDARD_DEVIATION 4 | 43.6 Years STANDARD_DEVIATION 13.3 | 29.8 Years STANDARD_DEVIATION 19.5 |
| Sex: Female, Male Female | 18339 Participants | 38211 Participants | 56550 Participants |
| Sex: Female, Male Male | 23414 Participants | 21473 Participants | 44887 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Mean Ratio of Controller Medication to Total Asthma Medication
The ratio of controller medication (CM) to total asthma medication (AM), which is well established in predicting future asthma events in adults, was calculated as the ratio of the units of CMs used during the defined period divided by the sum of the units of CMs plus the units of inhaled short-acting beta-agonists used during the same period. A CM is defined as any inhaled corticosteroid containing medication, methylxanthines, leukotriene receptor antagonists, or cromolyn sodium. The ratio is calculated using all CM. Asthma controllers are medications used to treat asthma on a regular basis.
Time frame: January 1, 2004 to June 30, 2006: 3, 6, and 12 month follow-up periods
Population: Ingenix Impact National Managed Care Database members who had \>=1 ICD-9 code for asthma and had \>= 1 controller medication or \>=5 albuterol canisters dispensed identified in the database during the 12-month identification period (pre-index). We tested 3 different capture/follow-up periods; thus, sample sizes varied depending capture period used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pediatric Participants Diagnosed With Asthma | Mean Ratio of Controller Medication to Total Asthma Medication | 12 months, n=40659, 59174 | 0.63 ratio | Standard Deviation 0.26 |
| Pediatric Participants Diagnosed With Asthma | Mean Ratio of Controller Medication to Total Asthma Medication | 6 months, n=40525, 59091 | 0.66 ratio | Standard Deviation 0.26 |
| Pediatric Participants Diagnosed With Asthma | Mean Ratio of Controller Medication to Total Asthma Medication | 3 months, n=40419, 59016 | 0.57 ratio | Standard Deviation 0.34 |
| Adult Participants Diagnosed With Asthma | Mean Ratio of Controller Medication to Total Asthma Medication | 6 months, n=40525, 59091 | 0.71 ratio | Standard Deviation 0.29 |
| Adult Participants Diagnosed With Asthma | Mean Ratio of Controller Medication to Total Asthma Medication | 12 months, n=40659, 59174 | 0.70 ratio | Standard Deviation 0.29 |
| Adult Participants Diagnosed With Asthma | Mean Ratio of Controller Medication to Total Asthma Medication | 3 months, n=40419, 59016 | 0.66 ratio | Standard Deviation 0.34 |
Mean Number of Short-acting Beta-agonist (SABA) Canisters Used
The number of albuterol canisters dispensed is a marker that is well established in predicting future asthma events in an adult population.
Time frame: January 1, 2004 to June 30, 2006: 3, 6, and 12 month follow-up periods
Population: Ingenix Impact National Managed Care Database members who had \>=1 ICD-9 code for asthma and had \>= 1 controller medication or \>=1 albuterol canister dispensed during the 12-month pre-index period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pediatric Participants Diagnosed With Asthma | Mean Number of Short-acting Beta-agonist (SABA) Canisters Used | 3 months | 1.03 canisters | Standard Deviation 0.9 |
| Pediatric Participants Diagnosed With Asthma | Mean Number of Short-acting Beta-agonist (SABA) Canisters Used | 6 months | 1.24 canisters | Standard Deviation 1.18 |
| Pediatric Participants Diagnosed With Asthma | Mean Number of Short-acting Beta-agonist (SABA) Canisters Used | 12 months | 1.72 canisters | Standard Deviation 1.86 |
| Adult Participants Diagnosed With Asthma | Mean Number of Short-acting Beta-agonist (SABA) Canisters Used | 3 months | 1.04 canisters | Standard Deviation 1.06 |
| Adult Participants Diagnosed With Asthma | Mean Number of Short-acting Beta-agonist (SABA) Canisters Used | 6 months | 1.28 canisters | Standard Deviation 1.57 |
| Adult Participants Diagnosed With Asthma | Mean Number of Short-acting Beta-agonist (SABA) Canisters Used | 12 months | 1.82 canisters | Standard Deviation 2.71 |