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

Completed

• Conditions: Asthma
• Interventions: Drug: Asthma treatment with an asthma-related medication and at least one asthma controller medication

• Registration Number: NCT01346852
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Study First Submitted: 2011-04-15
• Study First Submitted QC: 2011-05-02
• Study First Posted: 2011-05-03
• Results First Submitted: 2011-05-05
• Results First Submitted QC: 2011-05-05
• Results First Posted: 2011-06-01
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-25
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101437

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pediatric participants	Asthma treatment with an asthma-related medication and at least one asthma controller medication	Pediatric participants (age 4 to 17) with a diagnosis of asthma
Adult participants	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.