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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01328964
First received: March 4, 2010
Last updated: September 8, 2011
Last verified: August 2011

March 4, 2010
September 8, 2011
June 2009
May 2010   (final data collection date for primary outcome measure)
Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years [ Time Frame: January 1, 2000 to June 30, 2008 ] [ Designated as safety issue: No ]
The number of participants with an asthma-related event was computed during the follow-up period and was standardized by dividing by the total days of follow-up in each cohort since participants had different lengths of follow-up. Per 100 person years is equal to the percent of events that occurred during the observed time period of the study.
asthma related exacerbations [ Time Frame: at least 90 days post exposure ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01328964 on ClinicalTrials.gov Archive Site
  • Mean Monthly Asthma-related Costs (Pharmacy and Medical) During the Post-index Period [ Time Frame: 12 months prior to January 1, 2000 to June 30, 2008 ] [ Designated as safety issue: No ]
    The mean total asthma costs are a sum of pharmacy and medical costs. Costs were determined monthly from the pharmacy and medical encounters recorded in the managed care insurance database. All costs were summed for each participant over the 3-12 month follow-up period (post-index period), and a mean monthly cost was calculated by dividing by the follow-up for each participant.
  • Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years [ Time Frame: 12 months prior to January 1, 2000 to June 30, 2008 ] [ Designated as safety issue: No ]
    The number of participants with an asthma-related event was computed during the follow-up period and was standardized by dividing by the total days of follow-up in each cohort since participants had different lengths of follow-up. Per 100 person years is equal to the percent of events that occurred during the observed time period of the study.
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Comparison of Asthma-related Outcomes and Costs in Pediatric Subjects That Received Fluticasone Propionate, Budesonide or Montelukast in a Large Managed Care Population
Comparison of Asthma-related Outcomes and Costs in Pediatric Subjects That Received Fluticasone Propionate, Budesonide or Montelukast in a Large Managed Care Population

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
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Non-Probability Sample

Claims related to pediatric patients age 4-12 in the database with one or more outpatient pharmacy claims for fluticasone propionate 44 micrograms (FP44) or budesonide (BUD) or montelukast (MON) between January 1, 2000 and June 30, 2008.

Asthma
  • Drug: Fluticasone propionate
    fluticasone propionate 44 mcg
    Other Name: Flovent® is a registered trademark of GlaxoSmithKline
  • Drug: Budesonide
    budesonide
    Other Name: Singulair®is a registered trademark of Merck and Company
  • Drug: Montelukast
    montelukast
    Other Name: Rhinocort® is a registered trademark of AstraZeneca
Children Ages 4-11 with asthma
Children ages 4 to 11 with a diagnosis of asthma receiving a prescription for an asthma therapy
Interventions:
  • Drug: Fluticasone propionate
  • Drug: Budesonide
  • Drug: Montelukast
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9906
May 2010
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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
  • ages 4 to 11 years

Exclusion Criteria:

  • diagnosis of Cystic Fibrosis
  • ≥ 1 Rx claim for any asthma controller in the pre-index period
Both
4 Years to 11 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01328964
112608
No
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
August 2011

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