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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01346852
First received: April 15, 2011
Last updated: September 15, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention
Asthma
Drug: Asthma treatment with an asthma-related medication and at least one asthma controller medication

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Predictive Ability of Therapeutic Risk Factors in Pediatric and Adult Asthma Patients

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    The number of albuterol canisters dispensed is a marker that is well established in predicting future asthma events in an adult population.


Enrollment: 101437
Study Start Date: July 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   4 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01346852

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01346852     History of Changes
Other Study ID Numbers: 112607
Study First Received: April 15, 2011
Results First Received: May 5, 2011
Last Updated: September 15, 2011
Health Authority: United States: No Health Authority

Keywords provided by GlaxoSmithKline:
pediatrics
Medicaid
asthma
outcomes
asthma medication ratio

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014