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

NCT ID: NCT01346852

Last Updated: 2017-05-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

101437 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Pediatric participants

Pediatric participants (age 4 to 17) with a diagnosis of asthma

Asthma treatment with an asthma-related medication and at least one asthma controller medication

Intervention Type DRUG

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.

Adult participants

Adult participants (age 18 and older) with a diagnosis of asthma

Asthma treatment with an asthma-related medication and at least one asthma controller medication

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

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112607

Identifier Type: -

Identifier Source: org_study_id

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