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Predictive Ability of Therapeutic Risk Factors in Pediatric and Adult Asthma Patients

Predictive Ability of Therapeutic Risk Factors in Pediatric and Adult Asthma Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01346852
Enrollment
101437
Registered
2011-05-03
Start date
2009-07-31
Completion date
2010-04-30
Last updated
2017-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

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

DRUGAsthma 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.

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
4 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Mean Ratio of Controller Medication to Total Asthma MedicationJanuary 1, 2004 to June 30, 2006: 3, 6, and 12 month follow-up periodsThe 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

MeasureTime frameDescription
Mean Number of Short-acting Beta-agonist (SABA) Canisters UsedJanuary 1, 2004 to June 30, 2006: 3, 6, and 12 month follow-up periodsThe 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

ArmCount
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
Total101,437

Baseline characteristics

CharacteristicPediatric Participants Diagnosed With AsthmaAdult Participants Diagnosed With AsthmaTotal
Age, Continuous10.1 Years
STANDARD_DEVIATION 4
43.6 Years
STANDARD_DEVIATION 13.3
29.8 Years
STANDARD_DEVIATION 19.5
Sex: Female, Male
Female
18339 Participants38211 Participants56550 Participants
Sex: Female, Male
Male
23414 Participants21473 Participants44887 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Pediatric Participants Diagnosed With AsthmaMean Ratio of Controller Medication to Total Asthma Medication12 months, n=40659, 591740.63 ratioStandard Deviation 0.26
Pediatric Participants Diagnosed With AsthmaMean Ratio of Controller Medication to Total Asthma Medication6 months, n=40525, 590910.66 ratioStandard Deviation 0.26
Pediatric Participants Diagnosed With AsthmaMean Ratio of Controller Medication to Total Asthma Medication3 months, n=40419, 590160.57 ratioStandard Deviation 0.34
Adult Participants Diagnosed With AsthmaMean Ratio of Controller Medication to Total Asthma Medication6 months, n=40525, 590910.71 ratioStandard Deviation 0.29
Adult Participants Diagnosed With AsthmaMean Ratio of Controller Medication to Total Asthma Medication12 months, n=40659, 591740.70 ratioStandard Deviation 0.29
Adult Participants Diagnosed With AsthmaMean Ratio of Controller Medication to Total Asthma Medication3 months, n=40419, 590160.66 ratioStandard Deviation 0.34
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
Pediatric Participants Diagnosed With AsthmaMean Number of Short-acting Beta-agonist (SABA) Canisters Used3 months1.03 canistersStandard Deviation 0.9
Pediatric Participants Diagnosed With AsthmaMean Number of Short-acting Beta-agonist (SABA) Canisters Used6 months1.24 canistersStandard Deviation 1.18
Pediatric Participants Diagnosed With AsthmaMean Number of Short-acting Beta-agonist (SABA) Canisters Used12 months1.72 canistersStandard Deviation 1.86
Adult Participants Diagnosed With AsthmaMean Number of Short-acting Beta-agonist (SABA) Canisters Used3 months1.04 canistersStandard Deviation 1.06
Adult Participants Diagnosed With AsthmaMean Number of Short-acting Beta-agonist (SABA) Canisters Used6 months1.28 canistersStandard Deviation 1.57
Adult Participants Diagnosed With AsthmaMean Number of Short-acting Beta-agonist (SABA) Canisters Used12 months1.82 canistersStandard Deviation 2.71

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026