Last updated: 11/07/2018 04:54:50

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

GSK study ID
112607
See study documents
Clinicaltrials.gov ID
NCT01346852
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Predictive Ability of Therapeutic Risk Factors in Pediatric and Adult Asthma Patients
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Mean ratio of controller medication to total asthma medication

Timeframe: January 1, 2004 to June 30, 2006: 3, 6, and 12 month follow-up periods

Secondary outcomes:

Mean number of short-acting beta-agonist (SABA) canisters used

Timeframe: January 1, 2004 to June 30, 2006: 3, 6, and 12 month follow-up periods

Interventions:
  • Drug: Asthma treatment with an asthma-related medication and at least one asthma controller medication
    • Enrollment:
    101437
    Primary completion date:
    2010-01-05
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Stanford, Shah, D'Souza, Schatz. Predicting Asthma Outcomes in Patients within Commerically- insured and Medicaid Populations. Am J Manag Care. 2013;19(1):60-67.
    Medical condition
    Asthma
    Product
    fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
    Collaborators
    GSK
    Study date(s)
    July 2009 to May 2010
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    4+ years
    Accepts healthy volunteers
    No
    • Subjects with asthma as determined by ICD-9 codes and asthma drug use
    • at least 4 years of age
    • Subjects with COPD or treatment for COPD
    Inclusion and exclusion 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

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2010-01-05
    Actual study completion date
    2010-01-05

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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