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

April 15, 2011
September 15, 2011
July 2009
April 2010   (final data collection date for primary outcome measure)
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.
asthma related exacerbations [ Time Frame: over 1 year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01346852 on ClinicalTrials.gov Archive Site
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.
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Predictive Ability of Therapeutic Risk Factors in Pediatric and Adult Asthma Patients
Predictive Ability of Therapeutic Risk Factors in Pediatric and Adult Asthma Patients

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.

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Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Probability Sample

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

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.
  • Pediatric participants
    Pediatric participants (age 4 to 17) with a diagnosis of asthma
    Intervention: Drug: Asthma treatment with an asthma-related medication and at least one asthma controller medication
  • Adult participants
    Adult participants (age 18 and older) with a diagnosis of asthma
    Intervention: Drug: Asthma treatment with an asthma-related medication and at least one asthma controller medication
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
101437
April 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
4 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT01346852
112607
No
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP