N/A
Completed N=9,906
Comparison of Asthma-related Outcomes and Costs in Pediatric Subjects That Received Fluticasone Propionate, Budesonide or Montelukast in a Large Managed Care Population
Source: ClinicalTrials.gov NCT01328964 ↗Enrolled (actual)
9,906
Serious AEs
—
Results posted
May 2011
Primary outcomePrimary: Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years — 0.89; 0.61; 3.35; 5.30 asthma events per 100 person years — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years |
0.71; 0.62; 3.40; 4.76; 4.07; 5.29 | 0.0495 sig |
| SECONDARY Mean Monthly Asthma-related Costs (Pharmacy and Medical) During the Post-index Period |
26; 27; 21; 48; 48; 75 | <0.0001 sig |
| SECONDARY Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years |
0.71; 0.62; 3.40; 4.76; 4.07; 5.29 | 0.0495 sig |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01328964). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.