Last updated: 02/03/2020 20:00:10

Assessment of asthma-related resources after initiation of an inhaled corticosteroid switch: Observational study

GSK study ID
114941
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Clinicaltrials.gov ID
Not applicable
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: Assessment of asthma-related resources after initiation of an inhaled corticosteroid switch: Observational study
Trial description: Asthma is a leading cause of preventable hospitalizations, and it accounts for an estimated 14 million days of missed school and 100 million days of restricted activity yearly. It has been estimated that regular use of inhaled corticosteroids (ICSs) could reduce asthma hospitalizations by as much as 80%, and that the risk of death from asthma decreases by 21% for each additional ICS canister used. Previous research have shown that the ratio of the number of controller medications to the total number of asthma medications dispensed is a better predictor of subsequent asthma exacerbations than is the prescription of at least one controller medication. However, asthma exacerbations appear to represent a different dimension than chronic asthma symptoms and control.
The primary objective of this study is to examine asthma risk as measured by modified Asthma Medication Ratio (AMR) changes over a 7 year period adjusting for differences in baseline characteristics. The secondary objective is to assess the impact of changes in prescription patterns for ICS/long-acting beta agonist (LABA) on changes in modified AMR. An exploratory analysis will examine asthma risk trends before and after Fluticasone propionate-salmeterol xinafoate combination (FSC) formulary change year (2008). The test hypothesis for this study is that with the increase in the use of ICS/LABA compared to total controllers over time, there is a corresponding increase in asthma medication ratio and a decrease in asthma risk. The null hypothesis is that no difference is observed.
A retrospective cohort design using electronic medical and pharmaceutical claims data from the Sharp Rees-Stealy (SRS) physician group will be used to examine asthma risks in patients using asthma medications. Data from January 1, 2003 to December 31, 2010 will be available and will constitute the study period
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Controller-to-Total asthma medication ratio

Timeframe: quarterly for 7 years

Secondary outcomes:

The impact of increasing or decreasing ICS/LABA market share on changes in modified AMR

Timeframe: For a one year period prior to the index date and a one year period during the study period

Interventions:
  • Drug: controller medication
    • Enrollment:
    0
    Primary completion date:
    2013-31-01
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Richard H. Stanford, Saurabh Nagar, Xiwu Lin, Richard D. O'Connor. Use of ICS/LABA on asthma exacerbation risk in patients within a medical group. J Manag Care Spec Pharm.2015;21(11):1014-1019.
    Medical condition
    Asthma
    Product
    fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
    Collaborators
    Not applicable
    Study date(s)
    June 2012 to January 2013
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    4+ years
    Accepts healthy volunteers
    none
    • At least 4 years of age during the index year
    • Presence of at least one medical claim in the index year with a diagnosis of asthma in any field (International Classification of Disease, Ninth Edition, Clinical Modification (ICD 9 CM): 493.xx) in each year of observation.
    • Presence of at least one medical claim in the index year with a diagnosis of COPD in any field (ICD 9 CM: 490.xx, 491.0, 491.1, 491.20, 491.21, 491.22, 491.8, 491.9, 492.0, 492.8, 496.xx) in each year of observation.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • At least 4 years of age during the index year
    • Presence of at least one medical claim in the index year with a diagnosis of asthma in any field (International Classification of Disease, Ninth Edition, Clinical Modification (ICD 9 CM): 493.xx) in each year of observation.
    • Presence of at least one asthma controller medication or SABA in each year of follow up period
    • Continuous health plan eligibility in 2 years of the study period, 12 months pre and post index.
    Exclusion criteria:
    • Presence of at least one medical claim in the index year with a diagnosis of COPD in any field (ICD 9 CM: 490.xx, 491.0, 491.1, 491.20, 491.21, 491.22, 491.8, 491.9, 492.0, 492.8, 496.xx) in each year of observation.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
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    Scientific result summary
    Available language(s): English
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    Protocol
    Available language(s): English
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    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
    2013-31-01
    Actual study completion date
    2013-31-01

    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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