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
  Purpose

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.


Condition Intervention
Asthma
Drug: Fluticasone propionate
Drug: Budesonide
Drug: Montelukast

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 9906
Study Start Date: June 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Children Ages 4-11 with asthma
Children ages 4 to 11 with a diagnosis of asthma receiving a prescription for an asthma therapy
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

  Eligibility

Ages Eligible for Study:   4 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01328964

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01328964     History of Changes
Other Study ID Numbers: 112608
Study First Received: March 4, 2010
Results First Received: April 8, 2011
Last Updated: September 8, 2011
Health Authority: United States: No Health Authority

Keywords provided by GlaxoSmithKline:
pediatric
asthma
outcomes
inhaled cortcosteroids

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Budesonide
Montelukast
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Leukotriene Antagonists
Hormone Antagonists

ClinicalTrials.gov processed this record on October 01, 2014