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

NCT01328964 | Completed Results

• 1 other identifier: 112608
• Study Type: observational
• Target: 9,906
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Asthma

Keywords

pediatric; asthma; outcomes; inhaled cortcosteroids

Outcome Measures

Primary Outcomes (1)

• Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years

  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.

  January 1, 2000 to June 30, 2008

Secondary Outcomes (2)

• Mean Monthly Asthma-related Costs (Pharmacy and Medical) During the Post-index Period

  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

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

Study Arms (1)

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; Drug: Budesonide; Drug: Montelukast

Interventions

Fluticasone propionate DRUG

fluticasone propionate 44 mcg

Also known as: Flovent® is a registered trademark of GlaxoSmithKline

Children Ages 4-11 with asthma

Budesonide DRUG

budesonide

Also known as: Singulair®is a registered trademark of Merck and Company

Children Ages 4-11 with asthma

Montelukast DRUG

montelukast

Also known as: Rhinocort® is a registered trademark of AstraZeneca

Children Ages 4-11 with asthma

Eligibility Criteria

• Age: 4 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• diagnosis of Cystic Fibrosis
• ≥ 1 Rx claim for any asthma controller in the pre-index period

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone; Budesonide; Commerce; montelukast

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnenediones; Pregnenes; Pregnanes; Technology, Industry, and Agriculture

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2010
• First Posted: April 5, 2011
• Study Start: June 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: July 6, 2017
• Results First Posted: May 5, 2011

Record last verified: 2017-06