Last updated: 11/07/2018 04:55:04

Comparison of Asthma-related Outcomes and Costs in Pediatric Subjects that Received Fluticasone Propionate, Budesonide or Montelukast in a Large Managed Care Population

GSK study ID
112608
Clinicaltrials.gov ID
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: Comparison of Asthma-related Outcomes and Costs in Pediatric Subjects that Received Fluticasone Propionate, Budesonide or Montelukast in a Large Managed Care Population
Trial description: The objective of this study is to compare asthma-related exacerbations (emergency department (ED) or inpatient (IP) visit) and related cost in pediatric patients aged 4-11 years that received either fluticasone propionate 44 mcg (FP44) or budesonide (BUD) or montelukast (MON). This retrospective observational cohort analysis utilizes a large managed care database with linked pharmacy and medical claims. Patients with ≥ 1 pharmacy claim FP44 or BUD or MON between January 1, 2000 through June 30, 2008 (4-11 years old at time of index) with ≥ 1 diagnosis for asthma (ICD-9 493.xx) in the pre-index period and continuously eligible to receive healthcare services for 1-year pre-index and at least 30 days post-index. Dose of each inhaled corticosteroid was not known in the database. Follow-up was defined for each patient as the period beginning with the index date and ending with the last date of continuous claims history, switch to another asthma controller medication, or claim for an asthma related event (ED/IP visit or OCS use) post-index, whichever occurred first.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of asthma-related hospitalizations, asthma-related emergency department (ED) visits, and combined hospitalizations/ED visits represented per 100 person years

Timeframe: January 1, 2000 to June 30, 2008

Secondary outcomes:

Mean monthly asthma-related costs (pharmacy and medical) during the post-index period

Timeframe: 12 months prior to January 1, 2000 to June 30, 2008

Number of asthma-related hospitalizations, asthma-related emergency department (ED) visits, and combined hospitalizations/ED visits represented per 100 person years

Timeframe: 12 months prior to January 1, 2000 to June 30, 2008

Mean monthly asthma-related costs (pharmacy and medical) during the post-index period

Timeframe: 12 months prior to January 1, 2000 to June 30, 2008

Interventions:
  • Drug: Fluticasone propionate
  • Drug: Budesonide
  • Drug: Montelukast
  • Enrollment:
    9906
    Primary completion date:
    2010-01-04
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Richard H Stanford; Manan Shah; Sham L. Chaudhari. Clinical and Economic Outcomes Associated with Low-Dose Fluticasone Propionate versus Montelukast in Children with Asthma Aged 4 to 11 Years. Open Respir Med J. 2012;6:37-43.
    Medical condition
    Asthma
    Product
    fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
    Collaborators
    Not applicable
    Study date(s)
    June 2009 to April 2010
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    4 - 11 years
    Accepts healthy volunteers
    No
    • ICD-9 code for asthma
    • one or more outpatient pharmacy claims for fluticasone propionate 44mg or budesonide between January 1, 2000 and June 30, 2008
    • diagnosis of Cystic Fibrosis
    • ≥ 1 Rx claim for any asthma controller in the pre-index period

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

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

    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
    2010-01-04
    Actual study completion date
    2010-01-04

    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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