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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

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ClinicalTrials.gov Identifier: NCT01328964
Recruitment Status : Completed
First Posted : April 5, 2011
Results First Posted : May 5, 2011
Last Update Posted : July 6, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
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 or disease Intervention/treatment
Asthma Drug: Fluticasone propionate Drug: Budesonide Drug: Montelukast

Study Type : Observational
Actual Enrollment : 9906 participants
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
Study Start Date : June 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]
    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 :
  1. 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 ]
    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.

  2. 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 ]
    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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Ages Eligible for Study:   4 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01328964


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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01328964     History of Changes
Other Study ID Numbers: 112608
First Posted: April 5, 2011    Key Record Dates
Results First Posted: May 5, 2011
Last Update Posted: July 6, 2017
Last Verified: June 2017

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
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
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action