An observational study in Asthma, sponsored by GlaxoSmithKline. Completed. Open to participants aged 4 Years and older. Per ClinicalTrials.gov, last updated 2017-05-30.
Sponsored by GlaxoSmithKline · Observational
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 101,437 is above the median of 150 across 970 observational studies indexed under Asthma.
Browse Asthma studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study intends to identify subjects at least 4 years of age with asthma and using asthma medications
Exclusion Criteria:
Pediatric participants (age 4 to 17) with a diagnosis of asthma
Drug: Asthma treatment with an asthma-related medication and at least one asthma controller medication
Adult participants (age 18 and older) with a diagnosis of asthma
Drug: Asthma treatment with an asthma-related medication and at least one asthma controller medication
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.
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
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
| Milestone | Pediatric Participants Diagnosed With Asthma | Adult Participants Diagnosed With Asthma |
|---|---|---|
| Started | 41753 | 59684 |
| Completed | 41753 | 59684 |
| Not completed | 0 | 0 |
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.
| ratio | Pediatric Participants Diagnosed With Asthma | Adult Participants Diagnosed With Asthma |
|---|---|---|
| 3 months, n=40419, 59016 | 0.57 ± 0.34 | 0.66 ± 0.34 |
| 6 months, n=40525, 59091 | 0.66 ± 0.26 | 0.71 ± 0.29 |
| 12 months, n=40659, 59174 | 0.63 ± 0.26 | 0.70 ± 0.29 |
The number of albuterol canisters dispensed is a marker that is well established in predicting future asthma events in an adult population.
| canisters | Pediatric Participants Diagnosed With Asthma | Adult Participants Diagnosed With Asthma |
|---|---|---|
| 3 months | 1.03 ± 0.90 | 1.04 ± 1.06 |
| 6 months | 1.24 ± 1.18 | 1.28 ± 1.57 |
| 12 months | 1.72 ± 1.86 | 1.82 ± 2.71 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pediatric Participants Diagnosed With Asthma | — | — | — |
| Adult Participants Diagnosed With Asthma | — | — | — |
| Age, Continuous(Years) | Pediatric Participants Diagnosed With Asthma | Adult Participants Diagnosed With Asthma | Total |
|---|---|---|---|
| Mean | 10.1 ± 4.0 | 43.6 ± 13.3 | 29.8 ± 19.5 |
| Sex: Female, Male(Participants) | Pediatric Participants Diagnosed With Asthma | Adult Participants Diagnosed With Asthma | Total |
|---|---|---|---|
| Female | 18339 | 38211 | 56550 |
| Male | 23414 | 21473 | 44887 |
No study locations are listed for this record.
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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