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

May 25, 2017 updated by: GlaxoSmithKline
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

101437

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study intends to identify subjects at least 4 years of age with asthma and using asthma medications

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pediatric participants
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
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Ratio of Controller Medication to Total Asthma Medication
Time Frame: 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.
January 1, 2004 to June 30, 2006: 3, 6, and 12 month follow-up periods

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Number of Short-acting Beta-agonist (SABA) Canisters Used
Time Frame: 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.
January 1, 2004 to June 30, 2006: 3, 6, and 12 month follow-up periods

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

April 15, 2011

First Submitted That Met QC Criteria

May 2, 2011

First Posted (Estimate)

May 3, 2011

Study Record Updates

Last Update Posted (Actual)

May 30, 2017

Last Update Submitted That Met QC Criteria

May 25, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 112607

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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