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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01346852
• Other study ID #: 112607
• Status: Completed
• Phase: N/A
• First received: April 15, 2011
• Last updated: May 25, 2017
• Start date: July 2009
• Est. completion date: April 2010

Study information

• Verified date: May 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101437
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	January 1, 2004 to June 30, 2006: 3, 6, and 12 month follow-up periods
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.	January 1, 2004 to June 30, 2006: 3, 6, and 12 month follow-up periods